#Preclinical Assets Market Share | Explore Tumblr posts and blogs

cavixorg · 2 years ago

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Using its unique expanded genetic code technology platform, Ambrx Biopharma Inc.(AMAM stock) , a clinical-stage biologics firm, discovers and creates tailored precision biologics. Its lead product candidate, ARX788, is an anti-HER2-drug conjugate (ADC) that is being studied in numerous clinical trials to treat of breast cancer, stomach junction cancer, as well as other solid tumors. These trials, which are currently in Phase 2 and Phase 3, are also being conducted for the treatment of gastric and breast cancers that have metastasized and are HER2-positive. The company is also working on two earlier-stage product candidates: ARX305, an anti-CD70 ADC in investigational new chemical studies for the treatment of kidney cell carcinoma and other cancers. And ARX517, an anti-PSMA ADC in a Phase 1 clinical trial for the therapy of prostate cancer and other tumors. It is also creating additional multiple product candidates with an eye toward immuno-oncology applications, such as ARX102, an immuno-oncology IL-2 path agonist that targets and gamma receptors on cytotoxic T cells to activate the patient's own immune system, and ARX822, a fab-small macromolecular bispecific that is used in preclinical phase for cancers. Bristol Myers Squibb Company, AbbVie Inc., BeiGene, Sino Biopharmaceutical Co., Ltd., NovoCodex, and Elanco Animal Health are all partners of Ambrx Biopharma Inc. The business was founded in 2003, and its main office is in La Jolla, California. Who Are The Major Owners Of AMAM Stock? 17 investment banks and fund managers owned AMAM stock in Ambrx Biopharma over the previous two years. Fosun International Ltd ($37.88M), Adage Capital Partners GP L.L.C. ($17.37M), BlackRock Inc. ($11.75M), FMR LLC ($10.22M), Octagon Capital Advisors LP ($8.82M), Suvretta Capital Management LLC ($6.15M), and Millennium Management LLC ($2.82M) were the institutional investors with the largest investments. AMAM stock is held by institutions 44.21% of the time. In the past 24 months, institutional investors have purchased 9,197,182 shares altogether. This volume of purchases entails about $158.86M in transactions. In the past 24 months, investment banks have sold 274,909 shares in total. This share sale volume equates to roughly $1.55M in business. Institutional shareholders Cormorant Asset Management LP ($0.15M), BlackRock Inc. ($48.46K), Tudor Investment Corp Et Al ($39.86K), Ghisallo Capital Management LLC ($25K), and Renaissance Technologies LLC ($11.60K) all sold shares of Ambrx Biopharma in the past 24 months. Short Sellers Of Ambrx Biopharma? November saw a decrease in short interest in Ambrx Biopharma. 3,800 shares totaled short interest as of November 15th, which is a decrease of 20.8% from the 4,800 share total as of October 31st. The days-to-cover ratio is currently 0.1 days based on an average daily trading volume of 30,600 shares. Short sales of the company's shares make up about 0.0% of the total. Any online trading account can be used to buy shares of AMAM stock. WeBull, Vanguard Brokerage Services, TD Ameritrade, E*TRADE, Robinhood, Fidelity, and Charles Schwab are a few well-known online brokerages providing access to the American stock market. Competitors Of AMAM The top rivals of Ambrx Biopharma include Elevation Oncology (ELEV), Cortexyme, Idera Pharmaceuticals (IDRA), Rubius Therapeutics (RUBY), Jasper Therapeutics (JSPR), Entera Bio (ENTX), AIM ImmunoTech (AIM), ERYTECH Pharma (ERYP), Genetic Technologies (GENE), Surrozen (SRZN), and (CRTX). All of these businesses fall under the "medical" category. Ambrx Biopharma is not as well-liked by analysts as other Medical companies. AMAM stock has a consensus rating of Moderate Buy, whereas the typical consensus rating for healthcare firms is Buy. Ambrx Biopharma is disliked by customers more than other Medical businesses. Ambrx Biopharma had an outperform vote from 52.38% of people, versus an average of 66.26% for medical firms. Entera Bio And Ambrx Biopha

rma? Compared to Ambrx Biopharma, Entera Bio has smaller revenue but larger earnings. Shares in Ambrx Biopharma are held by institutions 44.2% of the time. Comparatively, institutional investors own 17.1% of the shares in Entera Bio. Shares of Ambrx Biopharma are held by company insiders to a 5.1% stake. Comparatively, insiders own 5.2% of the shares in Entera Bio. Solid organizational ownership is a sign that endowments, hedge funds, and big money managers are betting on a company's long-term ability to outperform the market. Compared to Entera Bio's profit income of -1,796.49%, Ambrx Biopharma has a net margin of 0.00%. Entera Bio's return on equity was beaten by Ambrx Biopharma's equity return of 0.00%. When compared by users, Entera Bio earned 157 more votes for outperformance than Ambrx Biopharma. Similarly, while just 52.38% of people gave Ambrx Biopharma an outstanding vote, 66.14% of users awarded Entera Bio an outperform rating. With a beta of 1.34, AMAM stock price is 34% less volatile than that of the S&P 500. Compared to the S&P 500, Entera Bio's share price is 84% more unpredictable with a beta of 1.84. Ambrx Biopharma received 48 more media mentions than Entera Bio in the past week. Ambrx Biopharma received 49 mentions according to us, while Entera Bio received just one. Shares Of Ambrx Rise After Promoting Early Safety Preliminary safety and effectiveness findings from the Phase 2 ACE-Breast-03 study were released by Ambrx Biopharma Inc. (NASDAQ: AMAM), which encouraged early safety data from the breast cancer candidate. In patients with HER2-positive mBC who are resistant or refractory to T-DM1, the data showed a 51.7% overall response rate (ORR) and a 100% disease control rate (DCR) after therapy with ARX788. Patients received therapy for a median of 7.2 months, as treatment is still ongoing. In China, Amrbrx's partner NovoCodex Biopharmaceuticals is currently conducting two Phase 3 trials so one registration-enabled Phase 2 study with ARX788, with readouts expected in 2023. The last check Friday's premarket session saw AMAM shares up 180.6% to $1.15. How Simple Is It For Ambrx Biopharma To Raise Money? Many people may be thinking that Ambrx Biopharma has to raise more money in the future because its income is falling and its operating cash flow is rising. Companies have the option of raising capital through debt or equity. Publicly traded corporations benefit greatly from the ability to sell investors shares in order to raise capital and finance expansion. By comparing a company's cash burn to its market capitalization, we may determine how much investors would be affected if the business had to issue capital to pay for the cash burn for an additional year. Ambrx Biopharma seems to have a market value of $20 million and spent $7 million last year, or 350% of its market value. We believe there is a substantial risk of financial hardship given how big that expenditure is in comparison to the company's market value, and we would be extremely cautious about keeping the AMAM stock. What Are The Average Rating And Price Objective For Ambrx Biopharma? Based on the current 1 controlled transaction and 1 buy rating for AMAM, the consensus opinion for AMAM stock is Moderate Buy, according to the 2 analysts who have issued ratings in the past year. Ambrx Biopharma's average 12-month price objective is $4.00, with a premium price target of $4.00 and a low cost target of $4.00. According to two Wall Street experts who have predicted the price of AMAM for the next year, the average price target is $11.00, with the maximum prediction for the company being $16.00 and the lowest prediction being $6.00. By April 2023, according to the majority of Wall Street analysts, the share price of Ambrx Biopharma might be $11.00. Is AMAM A Successful Business? The cash burn for AMAM is $70163000. It has at least a year's worth of coverage in the form of cash and short-term investments. AMAM has cash and short-term investments of

$111.72 million. This is sufficient to fund its $70.16M yearly cash burn. AMAM has a small 0.28 debt to equity ratio. On the balance sheet of AMAM, short-term assets outnumber long-term liabilities. On the balance sheet of AMAM, short-term assets exceed short-term liabilities. Cons: Over the past year, AMAM's profit margin has decreased from 325.6% to 1.729.9%. According to our examination of Ambrx Biopharma's cash position, its cash runway was comforting, but the ratio of its cash burn to market value has us a little concerned. We have very little faith in the company's capacity to control its cash burn after taking all the data stated in this article into account, and we predict it will need additional money. The Basics Of Ambrx Biopharma The value of AMAM stock is 43, which is higher than the average for the Biotechnology sector. Currently, 3 out of 7 due diligence tasks are being passed by AMAM. AMAM's Financials rating is 0, which is the same as the industry average for the Biotechnology sector. AMAM stock is presently failing 0 of 7 checks for due diligence. The AMAM stock forecast score is 0, which is the same as the sector average for biotechnology. AMAM stock is presently failing 0 of 9 checks for due diligence. The Performance score for AMAM stock is 71, which is higher than the industry average for biotechnology. Five out of ten due diligence checks are passing for AMAM. We disregard this dimension because Ambrx Biopharma has little or no historical dividend history. Recommendations Most Recent From AMAM Analysts On May 24, 2022, a Goldman Sachs analyst decreases their price objective for AMAM stock from $6 to $4 while maintaining a hold rating. On April 7, 2022, Joel Beatty, a high 17% analyst from Baird, commences covering on AMAM with a buy recommendation and publishes their $16.00 price target. On February 28, 2022, Corinne Jenkins of Goldman Sachs, a top 48% analyst, announces the beginning of covering on AMAM with such a hold recommendation and a $6.00 price target. In 2022, Should I Buy Or Sell Ambrx Biopharma Stock? In the past year, Ambrx Biopharma has received "buy," "hold," and "sell" evaluations from 2 Wall Street research analysts. For the stock, there is presently 1 hold rating and 1 buy rating. Wall Street research experts generally agree that investors should "buy" AMAM stock. On Friday, June 18th 2021, (AMAM) raised $126 million through an initial public offering. At a price of $17.00–$19.00 per share, the corporation issued 7,000,000 shares. The underwriters for the initial public offering were Goldman Sachs, BofA Securities, and Cowen. The time it would take for a corporation to exhaust its cash on hand at its current cash burn rate is known as its cash runway. Ambrx Biopharma had 111 million dollars in cash and no debt as of June 2022. Looking back at the previous year, the business spent $70 million. So, starting in June 2022, AMAM stock forecast had a financial runway of about 19 months. This is not too bad, and unless cash burn substantially decreases, it is safe to assume the financial runway is coming to an end. Ambrx Biopharma Stock Forecast 2022 While it is not anticipated that AMAM stock forecast annual earnings rate of growth of N/A will surpass the statistically important earnings growth rate of 9.29% for the US biotechnology industry, neither is it anticipated to surpass the average AMAM stock forecast earnings rate of growth of 70.08% for the US market. The revenue for AMAM stock forecast in 2022 is -$90,558,000. One Wall Street analyst predicted that AMAM stock forecast earnings would be -$75,691,975 on average in 2022, with the highest AMAM earnings prediction being -$75,691,975 and the top AMAM stock forecast being -$75,691,975. The current Earnings Per Share (EPS) for Ambrx Biopharma is $6.72. Analysts expect AMAM stock forecast EPS to be -$0.28 on average for 2022, with the lowest and highest estimates both coming in at -$0.28. Ambrx Biopharma Stock Forecast

2023 AMAM stock forecast is anticipated to make -$67,582,121 in 2023, with the smallest earnings estimate being -$67,582,121 and the actual figure being -$67,582,121. By April 7, 2023, analysts on Wall Street believe the share price of Ambrx Biopharma might reach $11.00. From the present share price of $4.54 for AMAM, the average AMAM stock forecast predicts a possible increase of 142.29%. AMAM stock forecast EPS is anticipated to be negative $0.25 in 2023.

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stocklivemarket · 2 years ago

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kritikarehani · 3 years ago

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Is TSLP a new game-changer for Severe Uncontrolled Asthma?

Severe Uncontrolled Asthma Highlights

Key Points

Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation

Tezspire helps in stopping inflammation at the source and has the potential to treat a broad population of severe asthmatic patients

Thymic stromal lymphopoietin (TSLP), which was primarily identified in 1994 as a cytokine produced by thymic stromal cells, a short-chain four α-helical bundle type I interleukin-2 (IL-2) family cytokine shares its homology with IL-7. It was observed to be quite similar to IL-25 and IL-33. Its ability to differentiate naïve CD4+ T lymphocytes in type 2 cells, produce IL-4, IL-5, and IL-13, and reduce the expression of interferon γ (IFN-γ) related to type 1 cells is well known. The expression of TSLP increases in the asthmatic airways and correlates with the expression of type 2-attracting chemokines and the severity of the disease.

In December 2021, AstraZeneca and Amgen’s Tezspire/tezepelumab got approval by the USA FDA as an add-on therapy for the treatment of patients affected with severe asthma. Tezspire acts at the top of the inflammatory cascade by targeting TSLP and was approved following a Priority Review by the USA FDA and based on the results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated dominance across every primary and key secondary endpoint in patients with severe asthma compared with placebo while adding to standard therapy.

Furthermore, it is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase II and III clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts allergic status, and fractional exhaled nitric oxide (FeNO). It is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

“The essential function of TSLP in immunological homeostasis and modulating inflammatory responses at mucosal barriers may explain why tezepelumab is so effective in treating severe uncontrolled asthma”

In May 2022, the data presented at the American Thoracic Society (ATS) International Conference 2022 showed based on a study that patients with severe, uncontrolled asthma demonstrated a higher proportion of substantial clinical responses to tezepelumab. The study uses data from the completed phase III, double-blind, placebo-controlled NAVIGATOR trial to conduct an on-treatment analysis of responses to tezepelumab (NCT03347279).

In the analysis, 51% of the patients received tezepelumab vs. placebo. Across response criteria, the proportion of responders was higher in the tezepelumab as compared with the placebo group for exacerbation reduction i.e. 85.4% vs. 67.5%; Asthma Control Questionnaire (ACQ)-6 total score (86.9% vs. 76.6%); an improvement from baseline pre-bronchodilator forced expiratory volume in one second (FEV1) i.e. 60.3% vs. 49.9%; and in Clinical Global Impression of Change (CGI-C) score (81.5% vs. 67.7%). The proportion of complete responders (those who achieved significant improvement on all measures) in the tezepelumab group as compared with the placebo cohort was double.

New novel approaches that are capable of blocking TSLP such as fully human single-chain fragment variables against TSLP, bi-functional drugs that combine anti-IL-13 monoclonal antibodies with an anti-TSLP mAb, a fusion protein consisting of the ectodomains of TSLPR and IL-7Ra that extend into the extracellular space which is also known as a TSLP-trap, fragments capable of upsetting the TSLP/TSLPR complex are also expected to enter the market. Some assets are under preclinical investigation e.g. Zweimab (monovalent bispecific) and Doppelmab (bivalent bispecific) which are novel highly potent bispecific anti-TSLP/IL13 antibodies. It has also been observed that Zweimab and Doppelmab have a stronger affinity to the human targets compared to parental antibody formats.

Both TSLP and IL-13 have arisen as important players in cellular signaling in asthma which is categorized by Th2 inflammation. According to DelveInsights’s analysis of the Severe Asthma market, Tezespire is expected to reach sales close to $2Bn for the 7 major markets by 2032. So far biological treatments appear to be a more preferred long-term treatment against type 2 inflammation in severe asthma to reduce OCS exposure. Although there have been no head-to-head comparisons of biologic medicines for asthma to date, the findings of these studies imply that tezepelumab is as effective as other treatments at reducing exacerbations.

For more detailed analysis, visit the Severe Asthma market.

To know more on Severe Uncontrolled Asthma Highlights, visit @ Severe Asthma Market Highlights.

#ATS conference 2022 #severe uncontrolled asthma #asthma #controlled asthma\#delveinsight #conferences 2022

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wiseguyreport1222 · 3 years ago

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your-dietician · 3 years ago

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Can-Fite Reports Second Quarter 2021 Financial Results & Provides Clinical Update

New Post has been published on https://depression-md.com/can-fite-reports-second-quarter-2021-financial-results-provides-clinical-update/

Can-Fite Reports Second Quarter 2021 Financial Results & Provides Clinical Update

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended June 30, 2021.

Corporate and Clinical Development Highlights Include:

Can-Fite Entered into Development and Commercialization Agreement in $3 Billion Veterinary Osteoarthritis Market – Can-Fite entered into a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use. The canine osteoarthritis market is projected to reach $3 billion by 2024.

Can-Fite Received a Notice Allowance in China for its NASH Patent – During the second quarter, Can-Fite received a Notice Allowance in China for its patent titled “An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation”. This patent, which has subsequently been issued to Can-Fite, addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, to reduce liver fat particularly in patients with NASH.

Patent Filed for A3AR-based Cannabis Compounds in the Treatment of Liver Diseases – Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis, which is associated with NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Phase III Psoriasis Study Nears Completion of Enrollment – The Phase III Comfort™ study completed enrollment of 75% of planned patients during the second quarter, with full enrollment expected in the coming weeks. The study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla®) in patients with moderate to severe plaque psoriasis. Topline results are expected Q1 2022.

Phase II COVID-19 Study Expands into Europe – Can-Fite’s ongoing Phase II study, under a U.S. FDA protocol, has been enrolling patients in Israel and expanded enrollment into Europe during the second quarter. The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in 40 patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.

Phase IIb NASH Study Receives Clearance from Israeli Ministry of Health – Can-Fite received clearance from the Israeli Ministry of Health to commence a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. Patient enrollment is expected to commence Q3 2021, ahead of the prior expected start date of Q4 2021. The Company expects to expand the study to additional clinical sites in Europe. A prior Phase IIa clinical trial of Namodenoson in the treatment of NASH met study endpoints showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has completed preparatory work for its pivotal Phase III study and plans to submit its study protocol and plans to Institutional Review Boards (IRBs) at potential clinical sites. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival.

Fortified Balance Sheet

On June 30, 2021 Can-Fite had approximately $7.5 million in cash, cash equivalents, and short-term deposits. The Company closed an additional $10 million registered direct offering in August 2021.

“We expect multiple milestones in the coming months including topline results from our Phase III psoriasis study, in addition to the commencement of our pivotal Phase III in liver cancer and Phase IIb in NASH. We believe positive topline results may lead to further expansion of our global distribution strategy which has included significant non-dilutive funding,” stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2021 were $0.39 million compared to revenues of $0.40 million during the six months ended June 30, 2020. The decrease is considered immaterial.

Research and development expenses for the six months ended June 30, 2021 were $3.81 million compared with $7.05 million for the same period in 2020. Research and development expenses for the first half of 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first six months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first six months of 2021. We expect research and development expenses will increase through 2021 and beyond.

General and administrative expenses were $1.89 million for the six months ended June 30, 2021 compared to $1.45 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees. We expect general and administrative expenses will remain at the same level through 2021.

Financial income, net for the six months ended June 30, 2021 was $0.20 million compared to financial expense, net of $0.12 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investment.

Can-Fite’s net loss for the six months ended June 30, 2021 was $5.09 million compared with a net loss of $8.23 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of June 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $7.53 million as compared to $8.26 million at December 31, 2020. The decrease in cash during the six months ended June 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma which were offset by Company’s operating activity.

The Company’s consolidated financial results for the six months ended June 30, 2021 are presented in accordance with US GAAP Reporting Standards.

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

June 30,

December

2021

31, 2020

Unaudited

Audited

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

1,025

8,268

Short-term deposits

6,512

–

Other receivable and prepaid expenses

1,745

1,057

Short-term investment

271

Total current assets

9,553

9,400

NON-CURRENT ASSETS:

Operating lease right of use assets

Property, plant and equipment, net

Total long-term assets

127

123

Total assets

9,680

9,523

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

June 30,

December

2021

31, 2020

Unaudited

Audited

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables

1,005

561

Current maturity of operating lease liability

Deferred revenues

1,002

334

Other accounts payable

309

331

Total current liabilities

2,359

1,269

NON-CURRENT LIABILITIES:

Long – term operating lease liability

Deferred revenues

3,341

2.156

Total long-term liabilities

3,366

2,180

CONTINGENT LIABILITIES AND COMMITMENTS

SHAREHOLDERS’ EQUITY:

Ordinary shares of NIS 0.25 par value – Authorized: 5,000,000,000 and 1,000,000,000 shares at June 30, 2021 and December 31, 2020, respectively; Issued and outstanding: 515,746,293 shares as of June 30, 2021; 463,769,463 shares as of December 31, 2020

37,008

33,036

Additional paid-in capital

96,386

97,380

Accumulated other comprehensive income

1,127

Accumulated deficit

(130,566

)

(125,469

)

Total equity

3,955

6,074

Total liabilities and shareholders’ equity

9,680

9,523

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

Six months ended

June 30,

2021

2020

Unaudited

Revenues

398

402

Research and development expenses

(3,810

)

(7,054

)

General and administrative expenses

(1,892

)

(1,455

)

Operating loss

(5,304

)

(8,107

)

Total financial income (expenses), net

207

(128

)

Net loss

(5,097)

(8,235

)

Total comprehensive loss

(5,097

)

(8,235

)

Deemed dividend

–

(715

)

Net loss attributed to ordinary shareholders

(5,097

)

(8,950

)

Basic and diluted net loss per share

(0.01

)

(0.04

)

Weighted average number of ordinary shares used in computing basic and diluted net loss per share

500,010,114

254,940,675

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

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jesse-pinkman123 · 4 years ago

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Immunotherapy Drugs Market Size, Trends, Shares, Insights and Forecast – 2018-2026

The market players in the Immunotherapy Drugs Market are actively seeking collaborations and partnerships for the development of novel immunotherapy drugs. For instance, in April 2018, Bristol-Myers Squibb Company (BMS) and Illumina Inc. collaborated to utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of BMS oncology portfolio. The collaboration helped to develop a diagnostic version of Illumina’s TruSight Oncology 500 assay, including tumor mutation burden (TMB), and microsatellite instability for immunotherapies.

Immunotherapy is the management of a disease by enhancing, suppressing, or inducing an immune response. Some immunotherapies are designed to magnify or elicit an immune response. They are known as activation immunotherapies. However, some immunotherapies that suppress or reduce the immune response are known as suppression immunotherapies. Cell-based immunotherapies are useful for some types of cancers. Immune effector cells including macrophages, dendritic cells, lymphocytes, cytotoxic T lymphocytes (CTL), natural killer cells (NK Cell), etc., work collectively to protect the body against cancer by aiming at abnormal antigens articulated on the facade of the tumor cells. Therapies including granulocyte colony-stimulating factor (G-CSF), imiquimod, interferons as well as parts of cellular membrane from bacteria are approved for medical use. Some of the others such as IL-7, IL-2, IL-12, synthetic cytosine phosphate-guanosine (CpG) oligodeoxynucleotides and glucans anda variety of chemokines are involved in preclinical and clinical studies.

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An increase in the prevalence of cancer and a number of autoimmune diseases, the demand for immunotherapy drugs is likely to increase. The impact of these diseases can be ascertained from the fact that cancer caused 9.6 million deaths in 2018, as reported by the World Health Organization (WHO). The organization further stated that around 70% of deaths from cancer occur in low and middle-income countries. Moreover, with the rising need for mAbs, the immunotherapy drugs market is anticipated to have a positive outlook till the end of the forecast period 2019-2027. MAbs have a high affinity towards the specific disease cells as well as areas that require treatment. Accordingly, they can be utilized for therapies such as antibody-directed enzyme prodrug therapy and radio immunotherapy. The increased use of these antibodies in the drug development process is likely to boost the market’s revenue making capacity over the forecast period.

Another important factor driving the growth prospects of the global immunotherapy drugs market is the materialization of biosimilars. Dissimilar to generic drugs that have active pharmaceutical ingredients like original drugs, biosimilars are nearly identical to their creator biologic compounds. In view of the fact that biosimilars are less expensive than biologics therefore the sale of biosimilars among the patients and hospitals is likely to rise considerably during the forecast period. This is expected to augment the overall growth of the immunotherapy drugs market.

On the basis of therapy area, the cancer segment is likely to hold the maximum market share in 2018. The large share along with the high growth of this segment is due to the high predilection for immunotherapy as a first line of treatment in the management of cancer thereby leading to rising demand for the global immunotherapy drugs. On the basis of product type, the mAbs segment accounted for the maximum share of the market. The improvement of new drugs as well as the entry of new molecules such as zanolimumab, elotuzumab, onartuzumab, and obinutuzumab into the market will drive the growth of the global immunotherapy drugs market over the forecast period.

Increasing prevalence of cancer and rise in demand from the Asia Pacific region will drive the overall immunotherapy drugs market

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According to National Cancer Institute, around 1,685,210 new cases of cancer are likely to be diagnosed in the U.S. in 2016 and about 595,690 people are estimated to die from the disease. Since immunotherapy is used as a first line of treatment in the management of cancer, the market immunotherapy drugs market will grow accordingly. North America is the largest region in the global immunotherapy drugs market and is expected to retain its dominance over the forecast period. Asia Pacific is likely to be the fastest-growing market over the forecast period. The elevated growth of this region can mainly be attributed to low cost of manufacturing of these drugs in the region, rising pricing and reimbursement scenario for immunotherapy drugs on the universal level and for major countries such as the Belgium, the U.K., France, Italy, Spain, Japan, China, and Australia. For instance, reimbursement scenario in the U.K. has impacted the cost of the drugs. Keytruda is an immunotherapy drug used for the treatment of melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), urothelial carcinoma, gastric cancer, and cervical cancer. Keytruda generally costs up to US$ 84,000 to the patients. To reduce the cost of this drug, the National Health Service (NHS) England, a publicly funded national healthcare system, and Merck & Co. Inc. entered into an agreement in June 2018, to reimburse the cost of this drug and provide it for routine use as per the National Institute for Health and Care Excellence (NICE) recommendations. NICE recommends NHS to provide reimbursements for this drug and make it affordable for the patients.

Similarly, in April 2018, Pfizer Inc. and Allogene Therapeutics Inc. entered into an asset contribution agreement to use Pfizer’s portfolio related to allogeneic CAR-T therapy, an investigational immune cell therapy, for cancer. This agreement acted as an attractive opportunity for Pfizer Inc. to continue the development of CAR-T therapy.

Some of the companies operating in the immunotherapy drugs market in the current scenario are GlaxoSmithKline, F. Hoffmann-La Roche AG, AbbVie, In., Merck & Co., Inc. Amgen, Inc., Bristol-Myers Squibb, Eli Lilly and Company, Novartis International AG, AstraZeneca plc and Johnson & Johnson.

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#Immunotherapy Drugs Market Size #Immunotherapy Drugs Maket

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ericvick · 4 years ago

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Moderna Coronavirus Vaccine Receives Third Regulatory Nod, Gritstone Rallies On Hedge Fund Stake, aTyr's COVID-19 Drug Data

Here’s a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Jan. 4)

ABIOMED, Inc. (NASDAQ: ABMD)

Arvinas Inc (NASDAQ: ARVN)

Atea Pharmaceuticals, Inc. (NASDAQ: AVIR)

Bioanalytical Systems, Inc. (NASDAQ: BASI)

BioNano Genomics Inc (NASDAQ: BNGO) (said its subsidiary Lineagen’s genetic tests identified novel variants in known autism risk genes)

BridgeBio Pharma Inc (NASDAQ: BBIO)

Clearpoint Neuro Inc (NASDAQ: CLPT)

Curis, Inc. (NASDAQ: CRIS)

DiaMedica Therapeutics Inc (NASDAQ: DMAC)

Eidos Therapeutics Inc (NASDAQ: EIDX) (proxy advisory firm Institutional Shareholder Services recommended Eidos merger with BridgeBio)

Endo International PLC (NASDAQ: ENDP)

Fulgent Genetics Inc (NASDAQ: FLGT)

I-Mab ADR (NASDAQ: IMAB)

Jaguar Health Inc (NASDAQ: JAGX)

Masimo Corporation (NASDAQ: MASI)

Ocugen Inc (NASDAQ: OCGN) (reacted to its Indian partner receiving conditional approval for coronavirus vaccine in the Indian market)

Organogenesis Holdings Inc (NASDAQ: ORGO)

Otonomy Inc (NASDAQ: OTIC)

PMV Pharmaceuticals Inc (NASDAQ: PMVP)

PRA Health Sciences Inc (NASDAQ: PRAH)

Precigen Inc (NASDAQ: PGEN)

Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN)

TRACON Pharmaceuticals Inc (NASDAQ: TCON)

United Therapeutics Corporation (NASDAQ: UTHR)

Vincera Pharma Inc (NASDAQ: VINC)

Vistagen Therapeutics Inc (NASDAQ: VTGN)

X T L Biopharmaceuticals Ltd (ASDAQ: XTLB)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 4)

4D Molecular Therapeutics Inc (NASDAQ: FDMT)

Aprea Therapeutics Inc (NASDAQ: APRE)

Calithera Biosciences Inc (NASDAQ: CALA) (reported adverse outcome for the Phase 2 study of telaglenastat in patients with advanced or metastatic renal cell carcinoma)

Intercept Pharmaceuticals Inc (NASDAQ: ICPT)

Vivos Therapeutics Inc (NASDAQ: VVOS)

Stocks In Focus Moderna Gets Israeli Regulatory Nod For Coronavirus Vaccine Candidate

Moderna Inc (NASDAQ: MRNA) announced that Israel’s Ministry of Health has given authorization to import Moderna’s mRNA-1273, its vaccine candidate against the novel coronavirus.

Story continues

“This is the third regulatory authorization for the COVID-19 Vaccine Moderna, and its first outside of North America,” said Stéphane Bancel, CEO of Moderna.

“We hope to continue to see authorizations in additional markets in the coming days, weeks and months.”

Israel has secured 6 million doses of mRNA-1273 and first deliveries are expected to begin shortly, the company said.

The stock was up 1.14% to $113 in premarket trading.

Roche’s Cancer Drug Combo Gets Breakthrough Therapy Designation For Lung Cancer

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said the FDA granted breakthrough therapy designation for tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, in combination with Tecentriq for the first-line treatment of people with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations

The stock edged up 0.22% to $44 in after-hours trading.

Gritstone Oncology Rallies On Insider, Fund Buying

Gritstone Oncology Inc (NASDAQ: GRTS) shares rallied in reaction to a filing which revealed that biotech-focused hedge fund EcoR1 Capital, LLC built up a 9.9% stake in the company.

A separate filing showed Thomas Woiwode, a member of the company’s board of directors, bought 1.35 million shares in the company at $3.71 each.

The stock was jumping 19.16% higher to $4.85 premarket Tuesday.

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

Tonix to Collaborate With Massachusetts General Hospital For Organ Transplant Rejection Treatment

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced the signing of a second research collaboration agreement with Massachusetts General Hospital to develop TNX-1500, a humanized monoclonal antibody that targets the CD40-ligand for the prevention and treatment of organ transplant rejection.

In premarket trading Tuesday, Tonix shares were jumping 8.39% to 78 cents.

Marker Announces Lifting of Clinical Hold On Acute Myeloid Leukemia Study

Marker Therapeutics, Inc. (NASDAQ: MRKR) said the FDA lifted the partial clinical hold on its Phase 2 trial investigating the safety and efficacy of MT-401, its lead, multi-tumor-associated, antigen-specific T cell product candidate for the treatment of post-transplant acute myeloid leukemia.

BioXcel Says BXCL501 Aces Phase 1b/2 Study In Treating Dementia-Related Agitation

BioXcel Therapeutics Inc (NASDAQ: BTAI) said its BXCL501, an orally dissolving thin film formulation of dexmedetomidine, met the primary and secondary endpoints of the TRANQUILITY Phase 1b/2 trial that evaluated the pipeline asset at the 60 mcg dose level for treating agitation related to dementia, including Alzheimer’s disease.

Topline results from the evaluated doses showed that BXCL501 was generally well-tolerated, with rapid and durable reductions observed in measures of acute agitation with the 60 mcg dose.

The stock was moving up 7.77% to $56.31 in premarket trading Tuesday.

Myovant’s Recently Approved Prostate Cancer Treatment Now Available In US

Myovant Sciences Ltd (NYSE: MYOV) announced the U.S. commercial availability of Orgovyx, the first and only oral gonadotropin-releasing hormone receptor antagonist approved by the FDA, for the treatment of adult patients with advanced prostate cancer.

In premarket trading Tuesday, Myovant shares were adding 3.06% to $25.59.

Checkmate Names Pharma Industry Veteran Robert Dolski As CFO

Checkmate Pharmaceuticals Inc (NASDAQ: CMPI) announced the appointment of biopharma industry veteran Robert Dolski as its chief financial officer.

The company also said it recently strengthened its leadership team by naming Katherine Eade as General Counsel.

aTyr’s Lead Candidate Aces Midstage Study In Hospitalized COVID-19 Patients

aTyr Pharma Inc (NASDAQ: LIFE) announced positive topline results from its Phase 2 clinical trial of its lead therapeutic candidate, ATYR1923, in hospitalized COVID-19 patients with severe respiratory complications who do not require mechanical ventilation.

The trial met its primary endpoint of safety, demonstrating that a single, intravenous dose of ATYR1923 was generally safe and well-tolerated in both the 1.0 and 3.0 mg/kg treatment groups, with no drug-related serious adverse events, the company said.

“We are very encouraged by the signal of clinical activity seen in the 3.0 mg/kg cohort of ATYR1923. The relatively faster time to recovery seen by adding a single dose of ATYR1923 to standard of care treatment and the greater proportion of patients recovering within a week compared to placebo give us further confidence in this signal,” said Sanjay Shukla, CEO of aTyr.

The stock was up 6.8% premarket at $4.24.

Zosano Requests FDA Meeting On Migraine Drug Application

Zosano Pharma Corp (NASDAQ: ZSAN) said on Dec. 30 that the company requested a Type A meeting with the FDA.

The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the NDA for its migraine treatment candidate Qtrypta following the complete response letter received on Oct. 20.

The FDA typically responds to a sponsor’s request for a Type A meeting, if granted, with a meeting scheduled within 30 days from the receipt of the request.

Zosano shares were trading 42.93% higher at 83 cents premarket Tuesday.

Cerecor Announces Positive Results Phase 2 Study Of CERC-002 In Hospitalized COVID-19 Patients

Cerecor Inc (NASDAQ: CERC) announced positive results from its exploratory, Phase 2 U.S.-based proof of concept trial of the human anti-LIGHT monoclonal antibody CERC-002 in hospitalized patients with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome.

The trial demonstrated robust improvement in the primary endpoint — the proportion of patients alive and free of respiratory failure over the 28-day study period — compared to placebo.

The stock was jumping 24.62% to $3.29 in premarket trading Tuesday.

ImmunoGen Insiders Buy Shares

ImmunoGen, Inc. (NASDAQ: IMGN) shares moved to the upside after a series of filings revealed purchase of the company’s shares by company insiders.

In after-hours trading, the stock gained 5.93% to $6.88.

Puma Biotechnology Shares Drop On Insider Selling

Puma Biotechnology Inc (NASDAQ: PBYI) shares came under pressure after a SEC filing on Form 4 revealed that its CEO Alan Auerbach sold 355 shares in the company at $11.656 per share. A separate filing showed that Richard Bryce, the company’s chief medical and scientific officer sold 92 shares at a price of $11.65 per share.

The stock shed 5.52% to $9.76 in after-hours trading.

Offerings

Generation Bio Co (NASDAQ: GBIO) said in a filing it plans to offer 7.5 million shares of its common stock in a follow-on offering.

In after-hours trading, the stock slipped 4.42% to $28.75.

Fate Therapeutics Inc (NASDAQ: FATE) said it has commenced an underwritten public offering of $350 million in shares of common stock.

The company said it intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies of its product candidates, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, the conduct of preclinical R&D, and for general corporate purposes.

The stock was down 4.10% to $86 in after-hours trading.

Prelude Therapeutics Inc (NASDAQ: PRLD) said it has commenced a public offering of 1.75 million shares of its common stock in a follow-on offering. All shares of common stock to be sold in the offering will be sold by the company.

NGM Biopharmaceuticals Inc (NASDAQ: NGM) said it has commenced an underwritten public offering of $100 million in shares of its common stock. All of the shares in the proposed offering will be sold by the company.

In after-hours trading, the stock fell 2.63% to $28.48.

On The Radar Clinical Readouts

Mersana Therapeutics Inc (NASDAQ: MRSN) is scheduled to release updated data from the ovarian cancer cohort of the Phase 1 expansion study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b. The presentation is due at the company’s virtual analyst and investor event.

Related Link: SVB Leerink Bullish On Silverback Therapeutics, Sees Diverse Pipeline

See more from Benzinga

#aTyrs #Coronavirus #COVID19 #data #Drug #Fund #Gritstone #Hedge #Moderna #nod #Rallies #receives #Regulatory #Stake #Vaccine

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supermarkettrends · 5 years ago

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Choroideremia Treatment Market Strategic Insights and key Business Influencing Factors | Major Players – Copernicus Therapeutics, Inc, Wize Pharma Inc, Spark Therapeutics, Inc, PIXIUM VISION, Retina Implant AG.

Choroideremia Treatment Market is also known as choroidal sclerosis is a rare, degenerative, X-linked inherited retinal disorder characterized by progressive degeneration of the choroid, retinal pigment epithelium (RPE) and retina due to Mutations in the CHM gene. This CHM gene required to produce Rab escort protein-1 (REP-1). The condition gets its name from the distinctive sweet odor of affected infant’s urine and is also c, a protein that takes part in targeting vesicles (small sacs of substances) into, out of, and within cells.

Global choroideremia treatment market is expected to grow at a steady CAGR in the forecast period of 2019-2026. Increase in strategic alliances between the pharmaceuticals companies and high demand of disease specific novel therapies are the key factors that fueling the market growth.

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Competitive Analysis: Global Choroideremia Treatment Market

Few of the major competitors currently working in the global choroideremia treatment market are Biogen, 4D Molecular Therapeutics, Copernicus Therapeutics, Inc, Wize Pharma Inc, Spark Therapeutics, Inc, PIXIUM VISION, Retina Implant AG, F. Hoffmann-La Roche Ltd and others

Key Pointers Covered in the Global Choroideremia Treatment Market Trends and Forecast to 2026

Global Choroideremia Treatment Market New Sales Volumes

Global Choroideremia Treatment Market Replacement Sales Volumes

Global Choroideremia Treatment Market Installed Base

Global Choroideremia Treatment Market By Brands

Global Choroideremia Treatment Market Size

Global Choroideremia Treatment Market Procedure Volumes

Global Choroideremia Treatment Market Product Price Analysis

Global Choroideremia Treatment Market Healthcare Outcomes

Global Choroideremia Treatment Market Cost of Care Analysis

Global Choroideremia Treatment Market Regulatory Framework and Changes

Global Choroideremia Treatment Market Prices and Reimbursement Analysis

Global Choroideremia Treatment Market Shares in Different Regions

Recent Developments for Global Choroideremia Treatment Market Competitors

Global Choroideremia Treatment Market Upcoming Applications

Global Choroideremia Treatment Market Innovators Study

Get Detailed TOC:

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Key Developments in the Market:

In June 2019, Biogen has acquired Nightstar Therapeutics for USD 800 million approximately. With this acquisition, Biogen will take the responsibility of two mid- to late-stage clinical assets, as well as preclinical programs in ophthalmology including NSR-REP1 for the treatment of choroideremia.

In November 2018, 4D Molecular Therapeutics received an Orphan Drug designation from the FDA for to 4D-110, an intravitreal injection AAV gene therapy agent for the treatment of choroideremia. With this designation company enables to obtain marketing exclusivity upon approval of the product in the designated indication.

Scope of the Choroideremia Treatment Market

Global Choroideremia Treatment Market By Treatment Type (Gene Therapy, Surgery), Route of Administration (Oral, Injectable), End- Users (Hospitals, Homecare, Specialty Clinics, Ophthalmic Clinics and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) - Industry Trends and Forecast to 2026

Choroideremia is also known as choroidal sclerosis is a rare, degenerative, X-linked inherited retinal disorder characterized by progressive degeneration of the choroid, retinal pigment epithelium (RPE) and retina due to Mutations in the CHM gene. This CHM gene required to produce Rab escort protein-1 (REP-1). The condition gets its name from the distinctive sweet odor of affected infant’s urine and is also c, a protein that takes part in targeting vesicles (small sacs of substances) into, out of, and within cells.

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Key insights in the report:

Complete and distinct analysis of the market drivers and restraints

Key Market players involved in this industry

Detailed analysis of the Market Segmentation

Competitive analysis of the key players involved

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Browse Related Report Here:

Ischemic Cerebral Stroke Market

Nocturnal Leg Cramps Treatment Market

#Choroideremia Treatment Market #Choroideremia Treatment Market share #Choroideremia Treatment Market size #Choroideremia Treatment Market trends #Choroideremia Treatment Market news #Choroideremia Treatment Market report #Choroideremia Treatment Market growth

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cavixorg · 2 years ago

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stocklivemarket · 2 years ago

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latestmarketreport · 5 years ago

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Medical Device Testing Services Market Profile Dynamics and Key Players Forecast To 2028

Global Medical Device Testing Services Market is estimated to stretch to US$ 13.4 billion by the year 2025. Growing expenditure in preclinical stage of medical devices, combined with increasing percentage of subcontracting is expected to benefit the market, in achieving important grip. The Medical Device Testing Services industry is expected to develop by the CAGR of 11.5% for the duration of the prediction.

Gushing demand for in-vitro test is moreover expected to trigger the demand for testing services such as a lot of CROs are evolving innovative in-vitro procedures to substitute outdated in-vivo systems, which have need of animal testing. Developments in processes for improvement and regularization of innovative in vitro test procedures, mainly for irritation, sensitization and cytotoxicity are too functioning in support of the market.

This Research will help you to understand the Volume, growth with Impacting Trends. Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) @ https://www.millioninsights.com/industry-reports/medical-device-testing-services-market/request-sample

The Medical Device Testing Services market on the source of Type of Phase could span Clinical, Preclinical. With reference to type of phase, the subdivision of preclinical testing detained the biggest stake of the market in 2016. The subdivision will carry on to take over the market during the course of the prediction, responsible for around two third of the general profits through 2025.

The Medical Device Testing Services industry on the source of Type of Service could span Certification Services, Testing Services Inspection Services, Environment Services, Asset Integrity Management Services, Technical Assistance & Training Services, Auditing Services, Quality-Safety-Health Services, Project Management Services, Consulting Services. Additional services are Antimicrobial Activity Testing, Pyrogen & Endotoxin testing, Microbiology & Sterility Testing, Biocompatibility Tests, Sterility Test & Validation, Bioburden Determination, Chemistry Test.

The subdivision of “chemistry test” is expected to display the speedy development for the duration of the prediction. The Medical Device Testing Services market on the source of Type of Technology could span Vascular Medical Device, Ophthalmic Medical Device, Non-Active Medical Device, Active Implant Medical Device, Orthopedic and Dental Medical Device, In-Vitro Diagnostic Medical Device, Active medical Device. Likewise, additional Medical Device Technologies are Medical Devices Utilizing Animal Origin, Mobile Devices, Medical Device with Ancillary Medicinal Substances.

The market report addresses the following queries related to the Medical Device Testing Services Market:

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· Which end-use industry is expected to hold the maximum market share in the Medical Device Testing Services Market?

· What are the recent mergers and acquisitions that have taken place in the Medical Device Testing Services Market?

Regional Analysis For Medical Device Testing Services Market:

For comprehensive understanding of market dynamics, the global Medical Device Testing Services Market is analyzed across key geographies namely: North America, Europe, Asia-Pacific, Latin America and Africa. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Potential and niche segments/regions exhibiting promising growth.

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bharatiyamedia-blog · 6 years ago

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Scholar Rock readies inventory providing - Scholar Rock Holding Company (NASDAQ:SRRK)

http://tinyurl.com/y5qo6ton Scholar Rock Holding (NASDAQ:SRRK) has commenced public providing 3M frequent shares. Underwriters over-allotment is an extra 0.45M frequent shares. Internet proceeds can be used to fund the preclinical actions for different pipeline packages, in addition to for working capital and different common company functions. Supply: Press Release window.SA = {"App":{"name":"SA","fullName":"Seeking Alpha","type":"regular","host":"https://seekingalpha.com","emailHost":"https://email.seekingalpha.com","pro":false,"proPlus":false,"contributorCenter":false,"realHostName":"https://seekingalpha.com","isCms":false,"cancelPV":false,"isSharkPreview":false,"usersOnSite":"7,523,450","assetHosts":["https://static.seekingalpha.com","https://static1.seekingalpha.com","https://static2.seekingalpha.com","https://static3.seekingalpha.com"],"moneData":{},"assetHost":"https://static.seekingalpha.com","userEchoHost":"https://feedback.seekingalpha.com","env":{"dev":false,"staging":false,"production":true,"test":false},"gaAccountId":"UA-1466493-1","comscoreAccountId":8500672,"fbAppId":"624608951014846","twitterAccountName":"SeekingAlpha","rollbarToken":"5edf110be2fc4cecb32637fc421111e2","perimeterXAppId":"PXxgCxM9By","embedlyKey":"a6da93fdfc49472099ce63260954716b","mp":false,"chat":{"host":"https://rc.seekingalpha.com"}},"pageConfig":{"Refresher":{"active":false},"Data":{"mc":{"id":3472265,"title":"Scholar Rock readies stock offering","primaryTicker":"srrk","primaryIsCrypto":false,"twitContent":"$SRRK - Scholar Rock readies stock offering https://seekingalpha.com/news/3472265-scholar-rock-readies-stock-offering?source=tweet","isSp500":false,"tags":["healthcare","small-cap"],"closest_trading_day":"2019-06-19","publishDate":"2019/06/18"},"pageType":"single_news","primaryTicker":"srrk","indexTickers":{}},"Ads":{"slots":[{"container":"news-left-slot-1","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{"tile":160},"size":[[160,600],"fluid"],"str":"160x600,fluid"},"cls":"mb25"},{"container":"news-right-slot-1","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{"tile":1},"size":[[300,250],[300,600],"fluid"],"str":"300x250,300x600,fluid"},"cls":"mb25","flex":true},{"container":"news-right-slot-2","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{"tile":100},"size":[[300,100]],"str":"300x100"},"cls":"mb25"},{"container":"news-right-slot-3","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{"tile":2},"size":[[300,252],"fluid"],"str":"300x252,fluid"},"cls":"mb25","native":true},{"container":"news-middle-slot","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{},"size":[[640,40]],"str":"640x40"},"cls":"mb25"},{"container":"news-bottom-slot","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{"tile":728},"size":[[728,90]],"str":"728x90"},"delay":true,"delta":500},{"container":"instream_recommendation_ad","data":{"name":"/6001/sek.news/single-post","disable_collapse_empty_div":false,"targeting":{"tile":50},"size":["fluid"],"str":"fluid"},"delay":true,"delta":500}],"testScroll":true,"disabled":false,"kvs":{"d":"news","t":["single-post","healthcare-news"],"mcid":[true,3472265],"tickerbundle":"zacks","cnt":["oil","14","fed","bny","fnk1","port"],"s":"SRRK"}},"Paths":{"int":{"adsAPI":{"src":"https://static3.seekingalpha.com/assets/api/ads-0cf8a56f1d93653afa4e33f67b12af5def2cb05353be15eeceffef0ad3d63d2f.js","id":"sa-ads-api"}},"ext":[{"src":"https://js-sec.indexww.com/ht/p/183642-162053219843577.js","id":"ie"},{"src":"https://www.googletagservices.com/tag/js/gpt.js","id":"gpt"},{"src":"https://pub.doubleverify.com/pub.js?ctx=818052u0026cmp=DV157324","id":"doubleverify"},{"src":"https://sb.scorecardresearch.com/beacon.js","id":"sb"},{"src":"https://ssl.google-analytics.com/ga.js","id":"ga"},{"src":"https://connect.facebook.net/en_US/sdk.js","id":"facebook-jssdk"}]},"lastRequested":"2019-06-19 00:07:16 -0400","SlugsPrices":{"disabled":false},"proOpenHouse":{"active":false,"end_date":"2017-03-20T06:00:00.000-04:00"},"proFlashSale":{"active":false,"end_date":"2017-03-23T00:00:00.000-04:00"},"saSource":null,"name":null,"useSQuoteBackup":null,"inFreeArticleTest":false,"featureCampaignVersion":null,"featureCampaignFlow":null,"skipAdoricFeatures":true},"headerConfig":{"noNotificationsMenu":null,"nonFixed":null,"tabless":null,"activeTab":"market-news"},"modules":{},"requires":[],"trackq":[],"exceptions":[],"gptInit":false}; Source link

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isiawgr-blog · 6 years ago

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Global Ulcerative Colitis Market Recent Trends, Growth Opportunities, Forecast by Application and Types to 2022

Ulcerative Colitis Market – Overview

The Market for Ulcerative Colitis is growing due to increasing demand for biologics for treating bowel disorders such as ulcerative collates and is propelling the overall market growth of global ulcerative market. Higher inclination for symptomatic therapeutic and drugs over surgeries, increase in patient assistance programs, better treatment and management of inflammatory bowel diseases, the arrival of advanced drugs in the market owing to healthier investments in R&D programs are some of the key trends governing the market.

Moreover, drug manufacturers are actively focusing on advanced products having higher efficiency. The growing patient population is an additional factor anticipated to influence the market growth between 2016 and 2022. Also, the increase in patient assistance programs is a major driver of the market. The provision of these programs by vendors will upsurge the preference for branded drugs because the out-of-pocket burdens would be less as the drugs are obtained at lower costs.

Ulcerative Colitis Market - Key Players

Key players profiled in the report are Allergan, Inc., AbbVie Inc., Takeda Pharmaceutical Company Limited, and Bayer AG, UCB S.A., Perrigo Company plc, Pfizer Inc., Johnson & Johnson Services, Inc., Ferring B.V., Janssen Biotech, and Merck

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Key Developments:

Companies are continuously developing new products to capture the market globally. Thus, major players invest more in research and development activity, in order to lead the global market. In this regard, market players undertake various strategic approaches.

Johnson & Johnson Services Inc.

September 2016: Acclarent Inc., a subsidiary of Johnson & Johnson, received FDA approval for ACCLARENT AERA Eustachian Tube Balloon Dilation System. It is a first FDA-approved device to treat Eustachian Tube Dysfunction effectively.

March 2016: Ethicon, a medical device company of the Johnson & Johnson, acquired NeuWave Medical, Inc.

June 2015: Verb Surgical Company was created by the collaboration of Ethicon and Verily.

March 2015: Ethicon, a medical device company of the Johnson & Johnson, enter into a collaboration with Google, Inc.

Pfizer Inc.

Pfizer Inc. is a leading research-based bio pharmaceutical organization. Pfizer apply science and our worldwide assets to convey inventive treatments that develop and essentially enhance lives. Pfizer makes medicines and vaccines that help individuals when they are sick and keep them from becoming sick in any case, and additionally a portion of some of the world’s best-known consumer healthcare brands.

August 2016: FDA approves Pfizer's TROXYCA ER extended-release capsules CII for pain management. This drug is used for abuse-deterrent properties for the management of pain and will help Pfizer to improve their goodwill and sales with this new product

July 2016: Bind Therapeutics entered into an asset purchase agreement with Pfizer Inc. Bind Therapeutics Inc. entered into an asset purchase agreement with Pfizer, Inc. On July 26, 2016, company amended the stalking horse agreement. The acquisition is expected to close on or about August 1, 2016.

July 2016: Pfizer and Western Oncolytics announce immuno-oncology research collaboration. This collaboration has the aim to investigate novel oncolytic virus technology. Under terms of agreement, Pfizer and Western Oncolytics will collaborate on preclinical, clinical development of WO-12 through Phase I trials. Financial terms of agreement are not disclosed

June 2016: Pfizer completed the acquisition of Anacor Pharmaceuticals. This acquisition has a motive for Pfizer, so that the company can accelerate their shared commitment to help patients with inflammatory disease, an area of high unmet medical need

Merck:

January 2017: Merck Acquired BioControl to Strengthen Position in Food Safety Testing

August 2012: Merck Acquired Cell Culture Media Specialist Biochrom AG

Allergan

November 2017- Allergan plc company announced its data will be presented at the annual American Academy of Ophthalmology (AAO) meeting in New Orleans, Louisiana, U.S. Allergan has a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. The company is an industry leader in Open Science, a model of research and development, which defines company's approach to identifying and developing ideas and innovation for better patient care.

August 2016- Allergan acquired eye care company ForSight VISION5 which added peri-ocular ring technology to Company's leading portfolio of innovative eye health products. Allergan has been a leader in the development and introduction of novel treatments for underserved eye conditions, including glaucoma, chronic dry eye disease and other ocular conditions. According to company reports, this acquisition of this ring technology that has profoundly change the way patients receive treatment. The ring is a preservative-free, non-invasive peri-ocular product that rests on the surface of the eye. It is inserted by an Ophthalmologist or Optometrist, and releases medication (bimatoprost) over multiple months to lower elevated IOP in glaucoma and ocular hypertensive patients.

Ulcerative Colitis Market - Segmentation

Global Ulcerative Colitis Market is segmented on the basis of types and medication. Based on types, the market is segmented as ulcerative proctitis, proctosigmoiditis, left-sided colitis, pancolitis or universal colitis, and fulminant colitis. Ulcerative proctitis is expected to command the largest market share during the forecast period. Further on the basis of medication the market is classified into 5-aminosalicylates, steroids, purine analogs, immunomodulators, and biologics. Biologics are expected to command the largest market. Steroids drugs are expected to grow at the highest CAGR during the forecast period.

Browse Complete 85 Pages Premium Research Report Enabled with Tables and Figures @https://www.marketresearchfuture.com/reports/ulcerative-colitis-market-2354

Global Ulcerative Colitis Market - Regional Analysis

The market of ulcerative colitis is much higher in the Americas region. In Americas, North America commands the largest market share of global ulcerative colitis market and is expected to grow at the same pace. Asia Pacific shows sufficient cases recoded for the disease due to lack of infrastructure and awareness and is expected to be the fastest growing segment with the highest CAGR due to continuous improvement in healthcare sector and increasing awareness among people. According to the US Center for Disease Control, there is an ulcerative colitis prevalence of 238 per 100,000 adults. The number of ulcerative colitis patients is increasing in emerging economies as per the development in technology, these developing or emerging economies are expected to account for the larger market share in coming future.

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At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services.

In order to stay updated with technology and work process of the industry, MRFR often plans & conducts meet with the industry experts and industrial visits for its research analyst members.

Contact: Market Research Future Office No. 528, Amanora Chambers Magarpatta Road, Hadapsar, Pune – 411028 Maharashtra, India +1 646 845 9312 Email: [email protected]

#Ulcerative Colitis Market

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niteshagrawals-blog · 6 years ago

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Tumor Necrosis Factor Alpha Market Estimation of Top Key Players Shares, Revenue, Analysis and Forecasts Till 2023

Market Scenario:

The tumor necrosis factor alpha (TNF-a) inhibitors represent one of the major treatment methods for inflammatory diseases. Globally, this drug class is known to be the most successful drugs in the overall pharmaceutical industry. Several conditions such as inflammations, rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and seronegative spondyloarthropathies, can be treated with the help of these drugs. The total sales of the top three blockbuster TNF-alpha inhibitors namely Remicade, Enbrel, and Humira had surpassed USD 32 billion in 2016.

Xalud’s lead product XT-150 harnesses the power of the body’s potent anti-inflammatory protein IL-10 to treat inflammatory diseases of the central nervous system (CNS) and joints. XT-150 is in the stage of the preclinical trials for multiple sclerosis, neuropathic pain, and osteoarthritis. In leading rodent model study for neuropathic pain XT-150 has been highly efficacious. Single injection delivers it into the fluid surrounding the spinal cord ensuring that the therapy reaches its target.

In the present scenario, developing countries have stringent regulatory requirements for approval of a new drug. It is a difficult task for marketing authorization application to get single regulatory for a new drug product which belongs to various categories of drugs such as NCE, biologicals, controlled drugs, etc. Therefore, the knowledge of precise and detailed regulatory requirements for market authorization application of different categories of drugs should be known to establish a suitable regulatory strategy. There is a need for pronounce and a fine balance between the persistence of gaining market access to pharmaceuticals, to protect the public health and facilitate healthy growth of pharmaceutical manufacturers.

Get Exclusive Report with Current Market Trend @ https://www.marketresearchfuture.com/sample_request/5538

Industry News:

In May 2016, Pfizer acquires Anacor for its inflammatory & immunology portfolio. Anacor is a biopharmaceutical company focused on small molecule therapeutics from its boron chemistry platform, and its asset Crisaborole is in FDA review if approved will be a first-line treatment option for patients with atopic dermatitis. They have entered into a definitive merger agreement under which Pfizer will acquire Anacor for approximately $5.2 billion which assumes the conversion of Anacor’s outstanding convertible notes. Anacor will be a strong fit with Pfizer’s innovative business due to the strategic focus on inflammation and immunology and is expected to enhance near-term revenue growth for the innovative business.

Key Players for Tumor Necrosis Factor Alpha Market:

AbbVie Inc. (U.S.), Ablynx (Belgium), Apogenix GmBH (Germany), AryoGen Biopharma (U.S.), Bionovis (Brazil), CASI Pharmaceuticals (U.S.), Celltrion Healthcare (South Korea.), Celgene Corporation (U.S.), Delenex Therapeutics (Switzerland), Dexa Medica (Indonesia), EPIRUS Biopharmaceuticals (U.S.), Janssen Biotech (U.S.), GlaxoSmithKline Inc. (U.S.), HanAll Biopharma (South Korea.), Intas Pharmaceuticals (India), LEO Pharma (Denmark), LG Life Sciences (U.S.), MedImmune (U.S.), Momenta Pharmaceuticals (U.S.), Novartis AG (Switzerland), Sanofi-Aventis (France), Zydus Cadila (India), and others.

Intended Audience

Tumor Necrosis Factor Alpha Inhibitors Drug Suppliers

Tumor Necrosis Factor Alpha Inhibitors Drug Manufacturers

Research and Development (R&D) Companies

Medical Research Laboratories

Academic Medical Institutes and Universities

Research Methodology

Global Tumor Necrosis Factor Alpha Market: Segmentation

The global tumor necrosis factor alpha inhibitors market is segmented on the basis of the drug, disorder type, route of administration, stage of clinical trials, and application.

On the basis of the drug, the global tumor necrosis factor alpha inhibitors market is segmented into Humira, Enbrel, Remicade, and others

On the basis of the disease type, the global tumor necrosis factor alpha inhibitors market is segmented into Alzheimer's diseases, Parkinson's diseases, ischemic stroke, multiple sclerosis, and others.

By the route of administration, the global tumor necrosis factor alpha inhibitors market is segmented into oral, subcutaneous, intravenous, and others.

On the basis of the stage of clinical trials, the global tumor necrosis factor alpha inhibitors market is segmented into the preclinical trial, phase 1 clinical trial, phase 2 clinical trial, phase 3 clinical trial, and phase 4 clinical trial.

On the basis of the application, the global tumor necrosis factor alpha inhibitors market is segmented into medicine, scientific research, and others.

Global Tumor Necrosis Factor Alpha Market: Regional Analysis

The global tumor necrosis factor alpha inhibitors market is segmented as the Americas, Europe, Asia Pacific and the Middle East and Africa.

The Americas is projected to hold the largest share of the global tumor necrosis factor alpha inhibitors market. P2D Biosciences, a US-based company, received $ 2.3 million funding from NIH (National Institutes of Health) with four grants. The grants include the development of new drugs for the treatment of acute leukemia and Alzheimer's disease and a new drug to improve stem cell transplant therapy for treating leukemia and lymphomas, which will help P2D to develop medical advances that improve the lives and health of people who are affected with these diseases.

Europe is expected to capture the second lead in this market in the coming five years owing to substantial technological advancements. In 2016, LEO Pharma, a Denmark based company entered biologics through a strategic partnership with AstraZeneca. The partnership will help LEO Pharma enhance their product portfolio. A strategic alliance with a healthcare giant will help LEO pharma expand their geographic presence and become a world leader in dermatology segment.

Moreover, Asia Pacific is expected to witness the fastest growth rate over the forecast period. The Middle East and Africa are also expected to show healthy growth in the coming five years.

Get Amazing Discount on Report @ https://www.marketresearchfuture.com/check-discount/5538

Some Brief Table of Contents of Report

Chapter 1. Report Prologue

Chapter 2. Market Introduction

2.1 Definition

2.2 Scope Of The Study

2.2.1 Research Objective

2.2.2 Assumptions

2.2.3 Limitations

Chapter 3. Research Methodology

3.1 Introduction

3.2 Primary Research

3.3 Secondary Research

3.4 Market Size Estimation

Chapter 4. Market Dynamics

4.1 Drivers

4.2 Restrains

4.3 Opportunities

4.4 Challenges

4.5 Macroeconomic Indicators

4.6 Technology Trends & Assessment

TOC Continued…

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At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Statistical Report, Continuous-Feed Research (CFR), and Market Research & Consulting Services.

Market Research Future

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Maharashtra, India

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#news #health

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otcsocialnetwork · 6 years ago

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Reply To: Stock Ticker Competition (Watchlist Format)

$CVSI add to watchlist. https://cvsciences.com/ https://pluscbdoil.com/ https://www.facebook.com/CVSciences/ CV Sciences, Inc. is a life science company that operates through two segments, specialty pharmaceuticals and consumer products. CV Sciences’ Consumer Products Division is engaged in the development, manufacturing, marketing and sale of consumer products containing plant-based CBD, which is refined into its own proprietary branded products. PlusCBD Oil is the top-selling brand of hemp-derived CBD oil for consumers in the natural products industry with a track record of excellence. PlusCBD Oil has built a reputation on product quality, safety and efficacy – offering the most diverse and largest supply of hemp-derived CBD oil on hand in the United States. Currently distributed nationally in health food stores, health care provider’s offices and online, each consumer products brand is backed by a formal safety review, growing body of case reports, and physician’s recommendations. Their products are in close to 2000 stores. CV Sciences’ Pharmaceutical Division is developing synthetically-formulated cannabidiol-based medicine, pursuing the approval of the U.S. Food and Drug Administration (FDA) for drugs with specific indications utilizing cannabidiol as the active pharmaceutical ingredient. CV Sciences has achieved promising preclinical results in the development of cannabinoid medicines for treatment of a range of medical conditions. CV Sciences initial drug candidate (CVSI-007) is a chewing gum that combines CBD and nicotine, which the Company believes has the potential to effectively treat smokeless tobacco use and addiction. The market for cessation of smokeless tobacco use and addiction is estimated at $2 billion, growing to over $4 billion in the next 5-6 years. SHARE STRUCTURE: OS: 92M Float: 76M AS: 190M No preferred shares issued. Balance sheet per Q1: Cash/AR/Restr.cash : $5.2 mln (includes $3.1 mln cash on hand) Total Assets: $23 mln Company fully repaid in cash ALL remaining outstanding convertible debt during Q1. Remaining debt balance of $850k is due in May 2019. This debt is NOT convertible. They expect to repay this debt from cash flow over the next several quarters. REVENUE: Total Revenue of 2016: $11 mln Total Revenue of 2017: $21 mln (almost 100% growth YoY) Q1 2017: $3.8 mln Q2 2017: $4.1 mln Q3 2017: $5.6 mln Q4 2017: $7.2 mln Q1 2018: $8.1 mln (over 100% growth from Q1 2017) Gross profit : $5.5 mln (you are not going to find stock in this industry with better margin) POSITIVE NET PROFIT of $620k CVSI NEWS and developments in the industry: CV Sciences, Inc. to Host Second Quarter 2018 Financial Results Conference Call on Wednesday August 1, 2018 CV Sciences, Inc. Files Application for Up-Listing to the NASDAQ Capital Market LAS VEGAS, July 23, 2018 (GLOBE NEWSWIRE) — CV Sciences, Inc. (OTCQB:CVSI), preeminent supplier and manufacturer of hemp-derived phytocannabinoids including cannabidiol (CBD) oil and developer of specialty pharmaceutical therapeutics, announced that it has submitted its application to list the Company’s common stock in the U.S. on the Nasdaq Capital Market. “We believe up-listing from the OTC Market to the Nasdaq Capital Market will increase corporate visibility, improve liquidity, and broaden awareness in the financial markets,” stated Joseph Dowling, Chief Executive Officer of CV Sciences. “An up-list will open the investment opportunity to a larger pool of investors and help create greater shareholder value. We have made significant progress in strengthening our financial performance and liquidity, positioning the Company for future growth and profitability. A listing on the Nasdaq Capital Market is a natural progression for the Company and our shareholders.” More article: https://globenewswire.com/news-release/2018/07/23/1540604/0/en/CV-Sciences-Inc-Files-Application-for-Up-Listing-to-the-NASDAQ-Capital-Market.html CV Sciences, Inc. Expands Retail Store Count of its Industry-Dominating Brand, PlusCBD Oil,™ in the Natural Products Industry LAS VEGAS, July 17, 2018 (GLOBE NEWSWIRE) — CV Sciences, Inc. (OTCQB:CVSI), preeminent supplier and manufacturer of hemp-derived phytocannabinoids including cannabidiol (CBD) oil and developer of specialty pharmaceutical therapeutics, announced that its flagship brand, PlusCBD Oil,™ continues to expand its distribution in the natural, healthy, and organic industry. The Company today announced that its brand of #1 selling hemp CBD products (according to SPINS® scan data) are currently available in 1968 natural and organic health food stores as of June 30, 2018. This represents an 11.1% sequential increase over the Company’s retail store count as of March 31, 2018. https://globenewswire.com/news-release/2018/07/17/1538322/0/en/CV-Sciences-Inc-Expands-Retail-Store-Count-of-its-Industry-Dominating-Brand-PlusCBD-Oil-in-the-Natural-Products-Industry.html Proper coding/labeling Regulation in Indiana – PlusCBD on news as a example of proper product labeling. https://www.wthr.com/article/new-labeling-rules-now-effect-all-cbd-oil-sold-indiana on June 28 U.S. Senate passed legislation (Farm Bill) that would legalize hemp as an agricultural commodity. The bill would legalize hemp, removing it from the federal list of controlled substances and allowing it to be sold as an agricultural commodity. The Senate’s farm bill still needs to be merged with a competing version from the House before it can be sent to the White House for President Trump’s signature. http://thehill.com/policy/finance/394741-senate-passes-legislation-to-legalize-hemp-as-agricultural-commodity FDA approved first CBD drug at the end of June. It is likely that the DEA will reclassify CBD in the next 90 days, says Stephanie Yip, an analyst at Informa Pharma Intelligence. (Epidiolex manufacturer GW Pharmaceuticals has said the same.) Most likely, according to Yip, it will be changed to Schedule IV or Schedule V, which are schedules that include other anti-seizure medications and anxiety drugs like Xanax and Klonopin. https://www.theverge.com/2018/6/29/17518424/epidiolex-cbd-cannabis-fda-drugs-policy-law-health CV Sciences, Inc. Issues Letter to Shareholders LAS VEGAS, June 27, 2018 (GLOBE NEWSWIRE) — CV Sciences, Inc., (OTCQB:CVSI) (the “Company,” “CV Sciences,” “our” or “we”), preeminent manufacturer and distributor of the industry-dominating brand of hemp extract products, PlusCBD Oil™, announced today that it has issued a letter to its shareholders, providing an update on the Company’s recent progress and upcoming objectives. Highlights of the Letter Include: •Summary of its record breaking and profitable first quarter of 2018 which included record revenue, gross profit, cash flow, adjusted EBITDA and net income. •Expansion of the Company’s footprint in the CBD product market with its PlusCBD Oil™ hemp-based CBD products rated #1 in the natural products retailer sales channel. This market opportunity is forecasted at $2.5 billion by 2022. •Updates on its drug development efforts, its proprietary patent-pending drug candidate (CVSI-007) to treat smokeless tobacco addiction, a $2 billion market opportunity. •Corporate developments that include deleveraging the Company’s balance sheet and positioning for future growth. •Details of CV Sciences’ upcoming annual general meeting (AGM) to be held on August 4, 2018 at the Company’s new San Diego headquarters. •Initiatives for 2018, focusing on operational efficiencies, sales growth, distribution channels, large drug development milestones that include investigational new drug application submission and clinical trials, and uplisting our stock to a major national exchange. The Company’s Chief Executive Officer, Joseph Dowling, commented, “Our uplist initiative to a major national exchange is an important Company objective. The national exchanges require that a listed company’s stock price trade at certain levels for acceptance. We have included a proposal for shareholder vote at our AGM on August 4, 2018 for a reverse stock split, which has as its sole purpose clearing a pathway for the Company to “uplist” to a major national exchange. The Company will effectuate the reverse split only in connection with an application to uplist to a major exchange, and only if necessary.” CV Sciences, Inc. Announces Landmark Publication on the Toxicology and Safety Assessment of Base Material of its PlusCBD Oil™ LAS VEGAS, June 15, 2018 (GLOBE NEWSWIRE) — CV Sciences, Inc. (OTCQB:CVSI) (the “Company”, “CV Sciences”, “our” or “we”) announced today the June 7, 2018 publication of the toxicology and safety results of an extract from the base raw materials used in its market leading PlusCBD Oil™ consumer products. The Company contracted respected scientific and regulatory consulting firm, AIBMR Life Sciences, Inc, to conduct the battery of toxicological studies to investigate the safety of oral consumption of the Company’s hemp cannabidiol (CBD) oil and to support a Generally Recognized as Safe (GRAS) Independent Conclusion. The investment in this toxicological assessment demonstrates CV Sciences’ commitment in furthering the science behind the ingredient. AIBMR’s Chief Scientific Officer, John Endres, ND, comments, “Until today, there have been no comprehensive toxicological safety assessments completed on hemp CBD oil for 38 years. The completion and publication of these safety studies on this ingredient in a peer-reviewed academic journal specializing in toxicology is a monumental step forward in putting competent and reliable science behind a product. The public should applaud this effort as well as the time and expense it required.” The Company’s Chief Executive Officer, Joseph Dowling, echoed this sentiment. “We are thrilled to advance phytocannabinoid science and are very pleased with the safety results from this landmark study. This is an important milestone in our pursuit of GRAS status,” he remarked. “As an organization, our commitment to safety remains paramount. We look forward to setting the bar for all hemp extract manufacturers in the market and encourage them to conduct similar toxicological assessments on their own base raw materials.” http://dlvr.it/QgRZ4T

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