MENLO PARK, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, announced today that its Chief Executive Officer, Steven Engle, will present a company update at the BIO Investor Forum, being held virtually on October 13-15, 2020. This presentation will be available on demand for BIO Investor attendees.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the worlds largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

About CohBar

CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics, an emerging class of drugs for the treatment of chronic and age-related diseases. Mitochondria based therapeutics originate from the discovery by CohBars founders of a novel group of naturally occurring peptide sequences within the mitochondrial genome,some of whichhave been shown tohave the potential to regulatekey processes inmultiplesystems andorgans in the body. To date, the company has discovered more than 100 mitochondrial derived peptides and generated over 1,000 analogs. CohBars efforts focus on the development of these peptides into therapeutics that offer the potential to address a broad range of diseasesbecause of the underlying impact of mitochondrial dysfunction. The companys lead compound, CB4211, is in the Phase 1b stage of a Phase 1a/1b clinical trial for NASH and obesity. In addition, CohBarhas four preclinical programs: CB5138 Analogs for fibrotic diseases,CB5064 Analogs for COVID-19 associated ARDS, MBT5 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.

For additional company information, please visit http://www.cohbar.com.

Forward-Looking Statements

This news release contains forward-looking statements which are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as believe, may, will, estimate, continue, anticipate, intend, could, should, would, project, plan, expect, goal, seek, future, likely or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to statements regarding anticipated outcomes of research and clinical trials for our mitochondria based therapeutic (MBT) candidates; expectations regarding the growth of MBTs as a significant future class of drug products; and statements regarding anticipated therapeutic properties and potential of our mitochondrial peptide analogs, MBTs and other potential therapies. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include: our ability to successfully advance drug discovery and development programs, including the delay or termination of ongoing clinical trials; our possible inability to mitigate the prevalence and/or persistence of the injection site reactions, receipt of unfavorable feedback from regulators regarding the safety or tolerability of CB4211 or the possibility of other developments affecting the viability of CB4211 as a clinical candidate or its commercial potential; results that are different from earlier data results including less favorable than and that may not support further clinical development; our ability to raise additional capital when necessary to continue our operations; our ability to recruit and retain key management and scientific personnel; the risk that our intellectual property may not be adequately protected; our ability to establish and maintain partnerships with corporate and industry partners; and risks related to the impact on our business of the COVID-19 pandemic or similar public health crises. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website, and at http://www.sec.gov orwww.sedar.com.

You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Contacts: Jordyn TaraziDirector of Investor RelationsCohBar, Inc.(650) 445-4441Jordyn.tarazi@cohbar.com

Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com

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CohBar to Present at the BIO Investor Forum - GlobeNewswire

Provention Bio Inc (PRVB) is near the top in its industry group according to InvestorsObserver. PRVB gets an overall rating of 68. That means it scores higher than 68 percent of stocks. Provention Bio Inc gets a 86 rank in the Biotechnology industry. Biotechnology is number 27 out of 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Provention Bio Inc (PRVB) stock is trading at $14.48 as of 2:24 PM on Monday, Oct 5, a rise of $1.12, or 8.38% from the previous closing price of $13.36. The stock has traded between $13.37 and $14.70 so far today. Volume today is less active than usual. So far 362,155 shares have traded compared to average volume of 632,466 shares.

Click Here to get the full Stock Score Report on Provention Bio Inc (PRVB) Stock.

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Should You Buy Provention Bio Inc (PRVB) in Biotechnology Industry? - InvestorsObserver

The 64 rating InvestorsObserver gives to Vericel Corp (VCEL) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 78 percent of stocks in the Biotechnology industry, VCELs 64 overall rating means the stock scores better than 64 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 64 would rank higher than 64 percent of all stocks.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

Vericel Corp (VCEL) stock is trading at $20.20 as of 2:12 PM on Monday, Oct 5, a rise of $0.74, or 3.8% from the previous closing price of $19.46. The stock has traded between $19.47 and $20.38 so far today. Volume today is less active than usual. So far 340,432 shares have traded compared to average volume of 550,330 shares.

Click Here to get the full Stock Score Report on Vericel Corp (VCEL) Stock.

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Is Vericel Corp (VCEL) a Winner in the Biotechnology Industry? - InvestorsObserver

A rating of 30 puts Ionis Pharmaceuticals Inc (IONS) near the bottom of the Biotechnology industry according to InvestorsObserver. Ionis Pharmaceuticals Inc's score of 30 means it scores higher than 30% of stocks in the industry. Ionis Pharmaceuticals Inc also received an overall rating of 38, putting it above 38% of all stocks. Biotechnology is ranked 27 out of the 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 38 would rank higher than 38 percent of all stocks.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Ionis Pharmaceuticals Inc (IONS) stock is trading at $46.79 as of 1:16 PM on Monday, Oct 5, an increase of $1.13, or 2.49% from the previous closing price of $45.65. The stock has traded between $46.04 and $47.20 so far today. Volume today is 1,079,820 compared to average volume of 926,841.

Click Here to get the full Stock Score Report on Ionis Pharmaceuticals Inc (IONS) Stock.

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Where Does Ionis Pharmaceuticals Inc (IONS) Stock Fall in the Biotechnology Field? - InvestorsObserver

A rating of 40 puts Vanda Pharmaceuticals Inc. (VNDA) near the middle of the Biotechnology industry according to InvestorsObserver. Vanda Pharmaceuticals Inc.'s score of 40 means it scores higher than 40% of stocks in the industry. Vanda Pharmaceuticals Inc. also received an overall rating of 43, putting it above 43% of all stocks. Biotechnology is ranked 27 out of the 148 industries.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Vanda Pharmaceuticals Inc. (VNDA) stock is trading at $10.18 as of 11:43 AM on Monday, Oct 5, a gain of $0.41, or 4.2% from the previous closing price of $9.77. The stock has traded between $9.87 and $10.19 so far today. Volume today is light. So far 112,006 shares have traded compared to average volume of 663,335 shares.

Click Here to get the full Stock Score Report on Vanda Pharmaceuticals Inc. (VNDA) Stock.

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Is Vanda Pharmaceuticals Inc. (VNDA) Stock Near the Top of the Biotechnology Industry? - InvestorsObserver

Arcturus Therapeutics Holdings Inc (ARCT) is near the top in its industry group according to InvestorsObserver. ARCT gets an overall rating of 70. That means it scores higher than 70 percent of stocks. Arcturus Therapeutics Holdings Inc gets a 87 rank in the Biotechnology industry. Biotechnology is number 27 out of 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 70 would rank higher than 70 percent of all stocks.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

Arcturus Therapeutics Holdings Inc (ARCT) stock is trading at $49.99 as of 1:11 PM on Monday, Oct 5, a rise of $7.20, or 16.83% from the previous closing price of $42.79. The stock has traded between $43.22 and $50.50 so far today. Volume today is low. So far 326,119 shares have traded compared to average volume of 737,857 shares.

Click Here to get the full Stock Score Report on Arcturus Therapeutics Holdings Inc (ARCT) Stock.

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Where Does Arcturus Therapeutics Holdings Inc (ARCT) Stock Fall in the Biotechnology Field? - InvestorsObserver

Evogene Ltd (EVGN) is near the top in its industry group according to InvestorsObserver. EVGN gets an overall rating of 65. That means it scores higher than 65 percent of stocks. Evogene Ltd gets a 82 rank in the Biotechnology industry. Biotechnology is number 27 out of 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 65 would rank higher than 65 percent of all stocks.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Evogene Ltd (EVGN) stock is trading at $4.30 as of 10:42 AM on Monday, Oct 5, a rise of $0.60, or 16.22% from the previous closing price of $3.70. The stock has traded between $3.81 and $4.38 so far today. Volume today is less active than usual. So far 543,565 shares have traded compared to average volume of 1,332,960 shares.

Click Here to get the full Stock Score Report on Evogene Ltd (EVGN) Stock.

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Is Evogene Ltd (EVGN) Stock Near the Top of the Biotechnology Industry? - InvestorsObserver

Vancouver, British Columbia, Canada - TheNewswire - October 5, 2020 - Global Cannabis Applications Corp. ("GCAC" or the "Company") (CSE:APP) , FSE: 2FA, (OTC:FUAPF), a leading commercial licensor of proprietary Data and AI technologies to the medical cannabis industry, today announced that it has signed a Memorandum of Understanding ("MOU") with Purity-IQ Incorporated of Canada ("Purity-IQ") (http://purity-iq.com/) to integrate the Purity-IQ Cannabis Authenticity and Purity Standard (CAPS) and its Fingerprint(TM) technology with the GCAC efficacy platform; with a focus on the Canadian medical cannabis and adult-use markets, which are forecast to grow to CA$4.1 billion in 20211.

Following on from its TraceLocker announcement on September 3rd, GCAC is attracting key players in the Canadian medical cannabis space. The company's MOU with Purity-IQ is a significant endorsement of the GCAC blockchain compliance and medical efficacy data collection platform. The proposed cooperation integrates GCAC's efficacy-data with Purity-IQ's CAPS Fingerprint(TM) service, a unique genetic and chemical profile of cannabis cultivars.

GCAC's blockchain medical efficacy smartphone app immutably links a specific Purity-IQ CAPS Fingerprint(TM) cultivar directly to a consumer's anonymous efficacy attestations. This is set to revolutionize the traceability of cannabis efficacy and bring it more in line with formal medical-trial information that a traditional dispensing pharmacist would be able to reference.

Purity-IQ can uniquely identify a cultivar based on a metabolite profile using Nuclear Magnetic Resonance (NMR) and DNA chip bioinformatics. The intent is for Purity-IQ Fingerprints to be referenced by GCAC's efficacy platform to verify 'batch-to-batch' consistency in medical cannabis efficacy programs.

GCAC's CEO, Brad Moore "I have no doubt that our smartphone efficacy-data platform is an industry leader for cannabis. Bringing the Purity-IQ scientific fingerprinting of cannabis cultivars, to which our consumers will report their efficacy, really builds a picture of what works for a consumer and what doesn't. This is where medical cannabis needs to get to and, we're bringing it there!"

Brad Moore continued, "With our blockchain truths and efficacy data-sets, medical practitioners, pharmacists, cultivators and processors gain efficacy data previously only found in formal drug trials. We change that and bring the wisdom-of-the-crowd to bear for medical cannabis efficacy."

Under the agreement, GCAC contributions regarding efficacy are the intellectual property ("IP") of GCAC. Securing GCAC's IP creates an inherent difficulty in replicating, or directly competing with, GCAC's medical cannabis solutions, and this is what the company believes makes GCAC one of the most exciting efficacy platforms in the cannabis and RegTech space.

1 https://www.yahoo.com/news/which-pot-stocks-will-survive-cannabis-bankruptcy-risk-131732204.html

About Global Cannabis Applications Corp.

Global Cannabis Applications Corp. is a global leader in designing, developing, marketing and acquiring innovative data technologies for the medical cannabis industry. The Citizen Green platform is the world's first end-to-end - from patient to regulator - medical cannabis data solution. It uses six core technologies: mobile applications, artificial intelligence, regtech, smart databases, blockchain and GCAC smart rewards to qualify candidates for clinical studies. These technologies facilitate the proliferation of digital conversations by like-minded people in the medical cannabis community. Driven by digital and cannabis industry experts, GCAC is focused on viral global expansion by providing the best digital experience in the cannabis market.

For more Company information, please visit http://www.cannappscorp.com, or review its profiles on http://www.sedar.com and on the Canadian Securities Exchange's website (www.thecse.com).

Purity-IQ IncorporatedPurity-IQ is a Canadian biotechnology company based in Mississauga, Ontario. It is committed to innovation in research and development and in the commercialization of practical and affordable validated quality assurance standards and tools, designed to further support brand product claims related to identity, authenticity, and purity. Purity-IQ focuses on commodities and inputs for the food, drug, beverage, natural health products and cannabis industries.

To schedule an interview, please contact: For more information, please contact:

Bradley Moore Corporate Communications

Chief Executive Officer Telephone: +1 (800) 409-5679

Email: bmoore@cannappscorp.com Email: info@cannappscorp.com

Forward-Looking Information

This news release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of GCAC. Forward-looking information is based on certain key expectations and assumptions made by the management of GCAC. Although management of the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because GCAC can give no assurance that they will prove to be correct. Forward-looking statements contained in this news release are made as of the date of this news release. GCAC disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy and accuracy of this information.

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GCAC Strengthens Its Medical Cannabis Efficacy Platform with Purity-IQ Biotechnology to Address a $4.1 Billion Market Opportunity - TheNewswire.ca

The agricultural biotechnologybusiness is anticipated to augment business germination in the projection period of 2020 to 2027 reckoning to USD 74.55 billion by 2027 expanding at an annual growth of 9.94% in the above-mentioned projection years.

The major players covered in the agricultural biotechnology market report areKWS SAAT SE & Co. KGaA, ChemChina, Corteva., Limagrain, MITSUI & CO., LTD., AgPlenus ltd., Biomica, Evogene Ltd., Canonic ltd., Bayer AG, Valent BioSciences LLC, Nufarm Limited, Marrone Bio Innovations., Performance Plants Inc., ADAMA Ltd. among other domestic and global players. Market share data is available for global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Download Sample PDF Copy of Reporthttps://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-agricultural-biotechnology-market

Global Agricultural Biotechnology Market Scope and Market Size

Agricultural biotechnology market is segmented on the basis of type, application, organism type, technology, and product. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

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Insights of the Study

Global Agricultural Biotechnology Market Drivers & Restraints :

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Covid-19 Update:Agricultural Biotechnology Market 2020||To Witness The Highest Growth Globally In Coming Years || MITSUI & CO., LTD., AgPlenus...

Phoenixville Public Library will host a free virtual presentation, Pandemics and the Role of Biotechnology in Vaccine Development, on Thursday, October 1 at 7:00 PM. Yelena Fayvilevich will be the speaker.Join us for a candid exploration by a local scientist of the science behind the Covid-19 pandemic and vaccines. Learn how biotechnology addresses the treatment of viral and bacterial infections. Yelena will touch on the history of pandemics and their reflection in literature and art, while addressing the current situation with Covid-19 and Ebola and the progress of vaccine development for Covid-19. A question-and-answer period will follow.

Yelena Fayvilevich has over 34 years of experience in biotechnology and science education. She is a Senior Chemical Engineer at Merck, and also owns her own company, Biotechnology and Innovation, dedicated to science education and the popularization of science. She has developed STEM programs for private schools, adult senior centers, and summer camps. She has a Master's degree in chemical engineering and biotechnology, and is a member of the American Chemical Society and the International Society of Pharmaceutical Engineers.

This event is free and open to the public, and will be held online/by phone via Zoom. Registration is required at https://ccls.libcal.com/calendar/Phoenixville/biotechnologyor by calling 610-933-3013 x132. For more information, e-mail mpinto@ccls.org.

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Pandemics and the Role of Biotechnology in Vaccine Development - Patch.com

Evogene Ltd (EVGN) is around the top of the Biotechnology industry according to InvestorsObserver. EVGN received an overall rating of 65, which means that it scores higher than 65 percent of all stocks. Evogene Ltd also achieved a score of 80 in the Biotechnology industry, putting it above 80 percent of Biotechnology stocks. Biotechnology is ranked 27 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Evogene Ltd (EVGN) stock is trading at $3.71 as of 2:53 PM on Friday, Oct 2, a drop of -$0.35, or -8.52% from the previous closing price of $4.05. The stock has traded between $3.55 and $3.88 so far today. Volume today is 1,164,778 compared to average volume of 1,291,117.

Click Here to get the full Stock Score Report on Evogene Ltd (EVGN) Stock.

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Is Evogene Ltd (EVGN) the Top Pick in the Biotechnology Industry? - InvestorsObserver

Data published online in Clinical Breast Cancer

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were published in Clinical Breast Cancer. The manuscript appears in the October 5, 2020 online issue accessible at https://www.clinical-breast-cancer.com/article/S1526-8209(20)30258-5/fulltext.

ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive eBC patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. Patients were stratified by hormone receptor status and randomly assigned to one year of treatment with either oral neratinib 240 mg/day or placebo. The primary endpoint of the trial was invasive disease-free survival (iDFS) with overall survival as a key secondary endpoint. Within the European Union, neratinib is approved in patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen.

The manuscript presents data focusing on HR+ patients who initiated treatment within a year of completing an adjuvant trastuzumab containing treatment (HR+ /< 1 yr) and subgroups of clinical interest including patients who did not achieve a pathological complete response (no pCR) after neoadjuvant treatment and therefore were at a high risk of disease recurrence. (HR+/ <1 yr, no pCR)

In the HR+ /< 1 yr patient population, the absolute 5-year invasive disease-free survival benefit versus placebo was 5.1% (HR=0.58, 95% CI 0.410.82) and absolute 8-year overall survival benefit was 2.1%. (HR=0.79, 95% CI 0.551.13). The 5-year cumulative incidence of CNS metastases was 0.7% in the neratinib arm and 2.1% in the placebo arm.

In the HR+/ <1 yr, no pCR subgroup of patients that were at a high risk of disease recurrence the absolute 5-year iDFS benefit in the neratinib arm versus placebo was 7.4% (HR=0.60; 95% CI 0.331.07) and the 8-year overall survival benefit was 9.1% (HR=0.47; 95% CI 0.230.92).

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Most common grade 3 adverse events were diarrhea (39% vs placebo, 1%; without mandatory anti-diarrheal prophylaxis), vomiting (4% vs <1%), and fatigue (2% vs <1%).

Professor Arlene Chan, Vice Chair Breast Cancer Research Centre WA, said, "Deciding on which patients benefit most from a given therapy is an important goal for clinicians. This newly published study provides consistent and durable benefits of neratinib in a subset of HER2-positive early stage breast cancer patients who are considered to be at greater risk of relapse: namely patients with HR+ tumors that did not achieve a pCR after neoadjuvant treatment (no pCR). The benefits demonstrated are meaningful in all endpoints evaluated, including iDFS, OS and CNS recurrence, and thus should help guide future clinical decisions."

Hope S. Rugo, MD, Professor of Medicine, University of California San Francisco Comprehensive Cancer Center, said, "HER2-positive HR+ patients who do not achieve a pCR are at increased risk of recurrence, even after receiving current standard of care treatment. In a descriptive subset analysis, extended adjuvant therapy with neratinib demonstrated a positive benefit in these patients not only in iDFS, but also in OS. In addition, the trend toward lower CNS involvement is a very important consideration, given the profound impact of CNS metastasis on future prognosis. These data coupled with the recently published data from the CONTROL study, which shows improved tolerability with dose escalation, should allow more patients to benefit from this important therapy."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "Although there have been many new treatment options for patients with early stage HER2-positive breast cancer, the risk of disease recurrence remains significant and more must be done. These newly published data demonstrate that neratinib provides a clinically meaningful reduction in the risk of recurrence and provides a very important option for these high risk patients."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade 2 diarrhea that occurs after maximal dose reduction.

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS:

The most common adverse reactions (reported in 5% of patients) were as follows:

NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.

NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and http://www.NERLYNX.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists.

Strong CYP3A4 inhibitors: Avoid concomitant use.

Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use.

Strong or moderate CYP3A4 inducers: Avoid concomitant use.

P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005904/en/

Contacts

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500info@pumabiotechnology.com ir@pumabiotechnology.com

David Schull or Maggie Beller, Russo Partners, +1 212 845 4200david.schull@russopartnersllc.com maggie.beller@russopartnersllc.com

Read more:
Puma Biotechnology Announces Publication of Overall Survival Results from Phase III ExteNET Trial Evaluating Neratinib in HER2-Positive, Hormone...

Here's a roundup of top developments in the biotech space over the last 24 hours.

(Biotech Stocks Hitting 52-week Highs Oct. 1)

(Biotech Stocks Hitting 52-week Lows Oct. 1)

Mesoblast(NASDAQ: MESO) said the FDA issued a complete response letter to its BLA for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease. The FDA has sought the company conduct at least one additional study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

Mesoblast said it will urgently request a Type A meeting with the FDA, which could be held within 30 days, to discuss a potential accelerated approval, with a post-approval condition for an additional study.

The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product's biologic activity, the company said.

The stock was on a T1 trading halt Thursday. In after-hours trading, the stock slumped 42.83% to $10.61.

Sanofi SA (NASDAQ: SNY) said the EMA accepted for review the marketing authorization application for avalglucosidase alfa, as a long-term enzyme replacement therapy for the treatment of patients with Pompe disease. Avalglucosidase alfa is an investigational enzyme replacement therapy, which, if approved, would offer a potential new standard of care for patients with Pompe disease.

The company expects EU approval for the therapy in the second half of 2021.

AstraZeneca plc (NASDAQ: AZN) said its Farxiga has been granted breakthrough therapy designation in the U.S. for patients with chronic kidney disease, with and without type 2 diabetes.

Metacrine Inc (NASDAQ: MTCR) announced new pharmacokinetic and pharmacodynamic data from its MET409 Phase 1b proof-of-concept clinical trial in patients with non-alcoholic steatohepatitis, or NASH, showing robust and sustained FXR activation, which is expected to be key to optimizing therapeutic benefits.

"Combined with a favorable pharmacological and tolerability profile, these results further highlight the therapeutic potential of MET409 for patients with NASH," the company said.

The company is scheduled to present these findings as two posters at the American Association for the Study of Liver Diseases' The Liver Meeting Digital Experience scheduled between Nov. 13 and 15.

The stock rose 4.17% to $10.50 in after-hours trading.

Aduro BioTech Inc (NASDAQ: ADRO) said at a special meeting of shareholders held Oct. 1, its shareholders approved its proposed merger with Chinook Therapeutics.

Following stockholder approval, the company announced a one-for-five reverse stock split. The shares will begin trading on a split-adjusted basis on Nasdaq, effective with the open of the market Friday.

The closing of the merger is anticipated to on or around Oct. 5. Following closing of the merger, the combined company will be renamed Chinook Therapeutics and trade under the trading symbol KDNY, Aduro said.

The stock was up 4.20% to $2.98 in after-hours trading.

Laboratory Corp. of America Holdings (NYSE: LH) said it received emergency use authorization from the FDA for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing. The advancement, the company said, will help improve the speed and efficiency of RT-PCR tests.

Xencor Inc (NASDAQ: XNCR) will present initial data from its Phase 1 dose-escalation study of tidutamab in patients with neuroendocrine tumors.

Exton, Pennsylvania-based Immunome, Inc., which uses its proprietary human memory B cell platform to discover and develop antibody therapeutics, priced its upsized initial public offering, or IPO, of 3.25 million shares of its common stock at $12, at the middle of the estimated price range of $11-$13. The offering is expected to raise gross proceeds of $39 million. The shares will begin trading on the Nasdaq under the ticker symbol IMNM.

Cancer immunotherapy company Oncorus, Inc. priced its 5.8-million-share IPO at $15 apiece, for raising gross proceeds of $87 million. The Cambridge, Massachusetts-based company had earlier estimated a price range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol ONCR.

Watertown, Massachusetts-based C4 therapeutics, Inc. priced its upsized IPO of 9.6 million shares at $19, above the estimated price range of $16-$18. The biopharma that develops therapeutic candidates to destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases, said it expects to raise gross proceeds of $182.4 million from the offering. The shares will commence trading on the Nasdaq under the ticker symbol CCCC.

2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Read more:
The Daily Biotech Pulse: Mesoblast Slumps On FDA Rejection, AstraZeneca's Breakthrough Therapy Designation, 3 IPOs - Benzinga

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Global Agriculture Biotechnology Market 2020 by Manufacturers,Demand,Size,Regions, Type and Application, Forecast to 2026 - Crypto Daily