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Capricor Announces Positive Top-Line Final Results from HOPE-2 Study in Patients with Duchenne Muscular Dystrophy Treated with Lead Candidate CAP-1002…

Posted: May 13, 2020 at 8:51 pm

-One-Year Results from Randomized, Double-Blind, Placebo-Controlled Study Demonstrate Improved Performance of Upper Limb (PUL) 2.0 (p=0.05)-

-First Ever Study in DMD that Correlates Stabilization in Cardiac Function with a Reduction in a Biomarker of Cell Damage-

-Company Planning to Meet with FDA to Discuss Pathway to Approval-

-To Host Conference Call and Webcast Today at 8AM ET-

LOS ANGELES, May 13, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics (Capricor) (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment and prevention of diseases, announced today positive top-line 12-month results of the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles. Boys and young men typically lose their ability to walk in their teens and generally die of cardiac or respiratory complications by the 3rd decade of life. The datashowed improvements in upper limb, cardiac and respiratory function with p-values less than p=0.05 in multiple measures.

The 12-month data from HOPE-2 showed statistically meaningful improvements in the PUL 2.0 in CAP-1002 treated patients (p=0.05) with a mean change of 2.4 points over placebo patients. With the exception of steroids, preservation of function in DMD is uncommon. The placebo patients declined consistent with natural history, but in the treated group, most patients were stable or improved throughout the one-year treatment period.

The performance of the upper limb (PUL) is a clinically validated measure that evaluates upper limb (shoulder, arm, hand) strength in patients who are generally non-ambulant. Retention of upper limb function is important for self-care and preservation of human dignity and has become a focus for physicians and advocates to find treatments to help these later stage patients. The FDA has suggested the use of the updated PUL 2.0 version as the primary efficacy endpoint in support of a Biologics License Application (BLA).

Craig McDonald, M.D., the national principal investigator for the HOPE-2 clinical trial and UC Davis professor and chair of the Department of Physical Medicine and Rehabilitation commented, I am incredibly pleased with the outcome of the HOPE-2 trial which demonstrated clinically relevant benefits of CAP-1002 which resulted in measurable improvements in upper limb, cardiac and respiratory function. This is the first clinical trial which shows benefit to patients in advanced stages of DMD for which treatment options are limited.

The data also showed global improvements in cardiac function as measured by ejection fraction (p=0.004) and indexed volumes (LVESV, p=0.01, LVEDV p=0.07). These are surrogate measures of cardiac function and are considered the gold standard in terms of relevance to long term outcomes. Remarkably, there is also a reduction in the biomarker CK-MB, an enzyme that is only released when there is cardiac muscle cell damage. In normal human subjects, there is typically no CK-MB measurable in the blood. It is well accepted that continuous muscle cell damage in DMD leads to pathologically high enzyme levels associated with cardiac muscle cell loss. HOPE-2 demonstrated a reduction in CK-MB levels as compared to placebo (p=0.006). This is the first ever study in DMD that correlates cardiac functional stabilization with reduction of a biomarker of cell damage.

Linda Marbn, president and CEO of Capricor said, To date, there are no therapies to treat the cardiomyopathy associated with DMD. Based on the statistically and clinically meaningful improvements in these and other measures of skeletal, cardiac and respiratory performance, we have requested an End-of-Phase 2 meeting with FDA to discuss next steps and a pathway to approval of a Biologics License Application for CAP-1002 in DMD.

Phase II HOPE-2 Study Design

HOPE-2 is a randomized, double-blind, placebo-controlled, Phase II clinical trial of the Companys lead investigational therapy, CAP-1002, in boys and young men who are in advanced stages of DMD. Study patients were treated via intravenous delivery with either CAP-1002 (150 million cells per infusion) or placebo every 3 months. Data from a total of 20 patients was analyzed (12 placebo and 8 treated) at the 12-month time-point in the intent to treat (ITT) population. Approximately 80% of the patients were non-ambulant and all patients were on a stable regimen of steroids. Demographic and baseline characteristics were similar between the two treatment groups.

Study Results

Top-Line Efficacy Data:

Mean Change from baseline to 12 months (standard deviation) shown.ITT (intent to treat) population shown P-values are nominal values unadjusted for multiple testing Mixed model repeated measures analysis

Dr. Marban continued, We are delighted with the final data from HOPE-2. It has met our expectations in terms of clinical meaningfulness in this population of patients where treatment options are extremely limited. In HOPE-2, CAP-1002 was delivered by intravenous infusions given quarterly. The data suggests that CAP-1002 could delay the progression of DMD. We are excited to share this data with FDA and discuss next steps towards commercialization. We have had tremendous support from the DMD advocacy community and we are grateful to the patients and families who participated in this study so that we could reveal the impact of CAP-1002 in treating DMD.

Safety Update

CAP-1002 was generally safe and well tolerated throughout the study. With the exception of hypersensitivity reactions which were mitigated with a common pre-medication regimen, no safety signals were identified in the HOPE-2 trial.

The FDA has granted Capricors CAP-1002 RMAT and Orphan Drug Designation, and the FDA has also granted a Rare Pediatric Disease Designation to CAP-1002 for DMD. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted, covers the broad treatment of DMD. If Capricor were to receive market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher. This is the second clinical trial investigating CAP-1002 showing similar results in DMD. Capricor completed the HOPE-Duchenne (Phase I/II) trial published in Neurology, the medical journal of the American Academy of Neurology in 2019.

The Company has initiated a technology transfer with a leading global CMO to prepare for commercial manufacturing of CAP-1002.

Conference Call and Webcast Details

Capricor will host a conference call and webcast with slides today, May 13, 2020, at 8:00 a.m. ET to discuss the top-line results of the HOPE-2 study. To participate in the conference call, please dial 855-327-6838 (domestic) or 604-235-2082 (international) and reference the access code: 10009621.

To participate via a webcast, please visit: http://public.viavid.com/index.php?id=139843 to view the slides. The webcast will be archived for approximately 30 days and will be available at http://capricor.com/news/events/.

Financial Update for the First Quarter of 2020

The Company reported a net loss of approximately $2.1 million, or $0.30 per share, for the first quarter of 2020, compared to a net loss of approximately $2.5 million, or $0.75 per share, for the first quarter of 2019.

As of March 31, 2020, the Companys cash, cash equivalents and marketable securities totaled approximately $13.2 million, compared to approximately $9.9 million on December 31, 2019. As of May 12, 2020, the Company has 12,464,006 shares issued and outstanding.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment and prevention of diseases. Capricors lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. The HOPE-Duchenne trial was funded in part by the California Institute for Regenerative Medicine. For more information,visit http://www.capricor.com and follow the Company on Facebook, Instagram and Twitter.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy is a devastating genetic disorder that causes muscle degeneration and leads to death, generally before the age of 30, most commonly from heart failure. It occurs in one in every 3,600 live male births across all races, cultures and countries. Duchenne muscular dystrophy afflicts approximately 200,000 boys and young men around the world. Treatment options are limited, and there is no cure.

About CAP-1002

CAP-1002 consists of allogeneic off-the-shelf cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune systems activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to approximately 150 human subjects across several clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricors exosome-based candidates have been approved for clinical investigation.

For more information, please contact:

Media Contact:Caitlin KasunichKCSA Strategic Communicationsckasunich@kcsa.com212.896.1241

Investor Contact:Joyce Allaire LifeSci Advisors, LLCjallaire@lifesciadvisors.com617.435.6602

Company Contact:AJ Bergmann, Chief Financial Officerabergmann@capricor.com310.358.3200

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Capricor Announces Positive Top-Line Final Results from HOPE-2 Study in Patients with Duchenne Muscular Dystrophy Treated with Lead Candidate CAP-1002...

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Extracellular Matrix Market to Reap Over US$ 47.46Mn in Revenues by End of 2027 – Cole of Duty

Posted: May 13, 2020 at 8:51 pm

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Life Science, and many more. Trade barriers are further restraining the demand- supply outlook.

Extracellular Matrix Market accounted to US$ 24.30 Mn in 2018 and is expected to grow at a CAGR of 8.2% during the forecast period 2019 2027, to account to US$ 47.46Mn by 2027.

The growth is driven by that countries such as China, Japan, and India which are engaged in conducting several studies. For instance, Australia is also involved in the several studies and also it has held various conferences for the tissue engineering and other application of the extracellular matrix.

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The potential of regenerative medicine that facilitates tissue regeneration in the affected area reduced the requirement of tissue transplant. The extracellular matrix is derived from a readily available tissue source, it can stimulate the growth of tissue in vivo with minimal inflammation, and it is available off the shelf. These advantages of the extracellular matrix enables in the ideal soft tissue replacement treatment procedures to repair contour defects. Therefore, there is increase in the vascular reconstruction or the plastic surgeries are anticipated to grow the extracellular matrix during the forecast period.

The studies for the molecular cell biology of extracellular matrix (ECM) are being conducted across the world. The cell adhesion molecules (CAMs), other properties and advantages of the extracellular matrix are turning out to be beneficial area of discovery with several interesting factors for disease and disorders in animals and humans. These advantages are also include treating of some cancers such as breast cancer, pancreatic cancer, liver cancer and colon cancer.

The globalextracellular matrix marketby raw material segments was led by porcine segment. In 2018, the porcine segment held a largest market share of 41.09% of the extracellular matrix market, by raw material. However, the bovine segment is expected to be the fastest growing segments of the market in 2027 owing to more beneficial properties to treat various conditions which is expected to become the major factor for the growth of the extracellular matrix market.

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Extracellular Matrix Market to Reap Over US$ 47.46Mn in Revenues by End of 2027 - Cole of Duty

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FDA Leaders to Speak at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference – PR Web

Posted: May 13, 2020 at 8:51 pm

ISPE drives industry-wide clarity of new regulations and guidance, advising on potential impact and facilitating practical solutions, seeking harmonization of regulatory expectations where desired and possible.

NORTH BETHESDA, Md. (PRWEB) May 13, 2020

The International Society for Pharmaceutical Engineering (ISPE) announced featured presenters representing the Food and Drug Administration (FDA) at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference. Taking place 12 June 2020, this first of its kind fully interactive digital event features timely and topical presentations and panel discussions from 40+ global experts representing FDA, GSK, Kite Pharma, Novartis, Roche, and more.

Featured FDA presenters will provide updates on regulatory expectations, considerations, and perspectives on biotechnology and biological products.

ISPE drives industry-wide clarity of new regulations and guidance, advising on potential impact and facilitating practical solutions, seeking harmonization of regulatory expectations where desired and possible, said Tim Howard, PE, CPIP, President & CEO, ISPE. It's vital that the biopharmaceutical industry pay close attention to what the regulators have to say and that we continue to develop constructive relationships.

FDA Presenters:

Wilson Bryan, MD, Director, Office of Tissues and Advanced Therapies, FDA/CBERDr. Bryans keynote presentation will provide insights into current developments in regenerative medicine, future trends, and challenges.

Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, FDA/CDERDr. Hughes will share regulatory considerations of innovations in sterile manufacturing and will also join the closing Fireside Chat.

Richard Friedman, Deputy Director, Science & Regulatory Policy, FDA/CDERFriedman will provide updates on sterile products and change management.

Raj Puri, MD, PhD, Director, Division of Cellular & Gene Therapies, FDA/CBERDr. Puri will participate in the closing Fireside Chat featuring global regulatory and industry leaders who are working to frame the strategy for the era ahead.

In addition to regulatory insights, industry experts will share their knowledge and lessons learned on critical topics, including:

To explore the educational agenda and to register, please visit ISPE.org/Bio20.

About ISPEThe International Society for Pharmaceutical Engineering (ISPE) is the worlds largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

For more information, contact: Amy HenryMarketing Communications ManagerInternational Society for Pharmaceutical Engineering (ISPE)Email: ahenry@ispe.org ISPE.org

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Human Embryonic Stem Cells (HESC) Market 2020 Global Share, Growth, Size, Opportunities, Trends, Regional Overview, Leading Company Analysis, And Key…

Posted: May 13, 2020 at 8:51 pm

Los Angeles, United State- The global Human Embryonic Stem Cells (HESC) market is carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the global Human Embryonic Stem Cells (HESC) market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the global Human Embryonic Stem Cells (HESC) Market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Human Embryonic Stem Cells (HESC) market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the global Human Embryonic Stem Cells (HESC) market.

Leading players of the global Human Embryonic Stem Cells (HESC) market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Human Embryonic Stem Cells (HESC) market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Human Embryonic Stem Cells (HESC) market. It also provides useful recommendations for new as well as established players of the global Human Embryonic Stem Cells (HESC) market.

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :https://www.qyresearch.com/sample-form/form/1749373/covid-19-impact-on-human-embryonic-stem-cells-hesc-market

Human Embryonic Stem Cells (HESC) Market Leading Players

ESI BIO, Thermo Fisher, BioTime, MilliporeSigma, BD Biosciences, Astellas Institute of Regenerative Medicine, Asterias Biotherapeutics, Cell Cure Neurosciences, PerkinElmer, Takara Bio, Cellular Dynamics International, Reliance Life Sciences, Research & Diagnostics Systems, SABiosciences, STEMCELL Technologies, Stemina Biomarker Discovery, Takara Bio, TATAA Biocenter, UK Stem Cell Bank, ViaCyte, Vitrolife, etc.

Human Embryonic Stem Cells (HESC) Segmentation by Product

, Totipotent Stem Cells, Pluripotent Stem Cells, Unipotent Stem Cells

Human Embryonic Stem Cells (HESC) Segmentation by Application

, Research, Clinical Trials, Others

Report Objectives

Analyzing the size of the global Human Embryonic Stem Cells (HESC) market on the basis of value and volume.

Accurately calculating the market shares, consumption, and other vital factors of different segments of the global Human Embryonic Stem Cells (HESC) market.

Exploring the key dynamics of the global Human Embryonic Stem Cells (HESC) market.

Highlighting important trends of the global Human Embryonic Stem Cells (HESC) market in terms of production, revenue, and sales.

Deeply profiling top players of the global Human Embryonic Stem Cells (HESC) market and showing how they compete in the industry.

Studying manufacturing processes and costs, product pricing, and various trends related to them.

Showing the performance of different regions and countries in the global Human Embryonic Stem Cells (HESC) market.

Forecasting the market size and share of all segments, regions, and the global market.

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Table of Contents.

1.1 Research Scope1.2 Market Segmentation1.3 Research Objectives1.4 Research Methodology1.4.1 Research Process1.4.2 Data Triangulation1.4.3 Research Approach1.4.4 Base Year1.5 Coronavirus Disease 2019 (Covid-19) Impact Will Have a Severe Impact on Global Growth1.5.1 Covid-19 Impact: Global GDP Growth, 2019, 2020 and 2021 Projections1.5.2 Covid-19 Impact: Commodity Prices Indices1.5.3 Covid-19 Impact: Global Major Government Policy1.6 The Covid-19 Impact on Human Embryonic Stem Cells (HESC) Industry1.7 COVID-19 Impact: Human Embryonic Stem Cells (HESC) Market Trends 2 Global Human Embryonic Stem Cells (HESC) Quarterly Market Size Analysis2.1 Human Embryonic Stem Cells (HESC) Business Impact Assessment COVID-192.1.1 Global Human Embryonic Stem Cells (HESC) Market Size, Pre-COVID-19 and Post- COVID-19 Comparison, 2015-20262.1.2 Global Human Embryonic Stem Cells (HESC) Price, Pre-COVID-19 and Post- COVID-19 Comparison, 2015-20262.2 Global Human Embryonic Stem Cells (HESC) Quarterly Market Size 2020-20212.3 COVID-19-Driven Market Dynamics and Factor Analysis2.3.1 Drivers2.3.2 Restraints2.3.3 Opportunities2.3.4 Challenges 3 Quarterly Competitive Assessment, 20203.1 Global Human Embryonic Stem Cells (HESC) Quarterly Market Size by Manufacturers, 2019 VS 20203.2 Global Human Embryonic Stem Cells (HESC) Factory Price by Manufacturers3.3 Location of Key Manufacturers Human Embryonic Stem Cells (HESC) Manufacturing Factories and Area Served3.4 Date of Key Manufacturers Enter into Human Embryonic Stem Cells (HESC) Market3.5 Key Manufacturers Human Embryonic Stem Cells (HESC) Product Offered3.6 Mergers & Acquisitions, Expansion Plans 4 Impact of Covid-19 on Human Embryonic Stem Cells (HESC) Segments, By Type4.1 Introduction1.4.1 Totipotent Stem Cells1.4.2 Pluripotent Stem Cells1.4.3 Unipotent Stem Cells4.2 By Type, Global Human Embryonic Stem Cells (HESC) Market Size, 2019-20214.2.1 By Type, Global Human Embryonic Stem Cells (HESC) Market Size by Type, 2020-20214.2.2 By Type, Global Human Embryonic Stem Cells (HESC) Price, 2020-2021 5 Impact of Covid-19 on Human Embryonic Stem Cells (HESC) Segments, By Application5.1 Overview5.5.1 Research5.5.2 Clinical Trials5.5.3 Others5.2 By Application, Global Human Embryonic Stem Cells (HESC) Market Size, 2019-20215.2.1 By Application, Global Human Embryonic Stem Cells (HESC) Market Size by Application, 2019-20215.2.2 By Application, Global Human Embryonic Stem Cells (HESC) Price, 2020-2021 6 Geographic Analysis6.1 Introduction6.2 North America6.2.1 Macroeconomic Indicators of US6.2.2 US6.2.3 Canada6.3 Europe6.3.1 Macroeconomic Indicators of Europe6.3.2 Germany6.3.3 France6.3.4 UK6.3.5 Italy6.4 Asia-Pacific6.4.1 Macroeconomic Indicators of Asia-Pacific6.4.2 China6.4.3 Japan6.4.4 South Korea6.4.5 India6.4.6 ASEAN6.5 Rest of World6.5.1 Latin America6.5.2 Middle East and Africa 7 Company Profiles7.1 ESI BIO7.1.1 ESI BIO Business Overview7.1.2 ESI BIO Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.1.3 ESI BIO Human Embryonic Stem Cells (HESC) Product Introduction7.1.4 ESI BIO Response to COVID-19 and Related Developments7.2 Thermo Fisher7.2.1 Thermo Fisher Business Overview7.2.2 Thermo Fisher Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.2.3 Thermo Fisher Human Embryonic Stem Cells (HESC) Product Introduction7.2.4 Thermo Fisher Response to COVID-19 and Related Developments7.3 BioTime7.3.1 BioTime Business Overview7.3.2 BioTime Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.3.3 BioTime Human Embryonic Stem Cells (HESC) Product Introduction7.3.4 BioTime Response to COVID-19 and Related Developments7.4 MilliporeSigma7.4.1 MilliporeSigma Business Overview7.4.2 MilliporeSigma Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.4.3 MilliporeSigma Human Embryonic Stem Cells (HESC) Product Introduction7.4.4 MilliporeSigma Response to COVID-19 and Related Developments7.5 BD Biosciences7.5.1 BD Biosciences Business Overview7.5.2 BD Biosciences Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.5.3 BD Biosciences Human Embryonic Stem Cells (HESC) Product Introduction7.5.4 BD Biosciences Response to COVID-19 and Related Developments7.6 Astellas Institute of Regenerative Medicine7.6.1 Astellas Institute of Regenerative Medicine Business Overview7.6.2 Astellas Institute of Regenerative Medicine Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.6.3 Astellas Institute of Regenerative Medicine Human Embryonic Stem Cells (HESC) Product Introduction7.6.4 Astellas Institute of Regenerative Medicine Response to COVID-19 and Related Developments7.7 Asterias Biotherapeutics7.7.1 Asterias Biotherapeutics Business Overview7.7.2 Asterias Biotherapeutics Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.7.3 Asterias Biotherapeutics Human Embryonic Stem Cells (HESC) Product Introduction7.7.4 Asterias Biotherapeutics Response to COVID-19 and Related Developments7.8 Cell Cure Neurosciences7.8.1 Cell Cure Neurosciences Business Overview7.8.2 Cell Cure Neurosciences Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.8.3 Cell Cure Neurosciences Human Embryonic Stem Cells (HESC) Product Introduction7.8.4 Cell Cure Neurosciences Response to COVID-19 and Related Developments7.9 PerkinElmer7.9.1 PerkinElmer Business Overview7.9.2 PerkinElmer Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.9.3 PerkinElmer Human Embryonic Stem Cells (HESC) Product Introduction7.9.4 PerkinElmer Response to COVID-19 and Related Developments7.10 Takara Bio7.10.1 Takara Bio Business Overview7.10.2 Takara Bio Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.10.3 Takara Bio Human Embryonic Stem Cells (HESC) Product Introduction7.10.4 Takara Bio Response to COVID-19 and Related Developments7.11 Cellular Dynamics International7.11.1 Cellular Dynamics International Business Overview7.11.2 Cellular Dynamics International Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.11.3 Cellular Dynamics International Human Embryonic Stem Cells (HESC) Product Introduction7.11.4 Cellular Dynamics International Response to COVID-19 and Related Developments7.12 Reliance Life Sciences7.12.1 Reliance Life Sciences Business Overview7.12.2 Reliance Life Sciences Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.12.3 Reliance Life Sciences Human Embryonic Stem Cells (HESC) Product Introduction7.12.4 Reliance Life Sciences Response to COVID-19 and Related Developments7.13 Research & Diagnostics Systems7.13.1 Research & Diagnostics Systems Business Overview7.13.2 Research & Diagnostics Systems Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.13.3 Research & Diagnostics Systems Human Embryonic Stem Cells (HESC) Product Introduction7.13.4 Research & Diagnostics Systems Response to COVID-19 and Related Developments7.14 SABiosciences7.14.1 SABiosciences Business Overview7.14.2 SABiosciences Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.14.3 SABiosciences Human Embryonic Stem Cells (HESC) Product Introduction7.14.4 SABiosciences Response to COVID-19 and Related Developments7.15 STEMCELL Technologies7.15.1 STEMCELL Technologies Business Overview7.15.2 STEMCELL Technologies Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.15.3 STEMCELL Technologies Human Embryonic Stem Cells (HESC) Product Introduction7.15.4 STEMCELL Technologies Response to COVID-19 and Related Developments7.16 Stemina Biomarker Discovery7.16.1 Stemina Biomarker Discovery Business Overview7.16.2 Stemina Biomarker Discovery Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.16.3 Stemina Biomarker Discovery Human Embryonic Stem Cells (HESC) Product Introduction7.16.4 Stemina Biomarker Discovery Response to COVID-19 and Related Developments7.17 Takara Bio7.17.1 Takara Bio Business Overview7.17.2 Takara Bio Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.17.3 Takara Bio Human Embryonic Stem Cells (HESC) Product Introduction7.17.4 Takara Bio Response to COVID-19 and Related Developments7.18 TATAA Biocenter7.18.1 TATAA Biocenter Business Overview7.18.2 TATAA Biocenter Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.18.3 TATAA Biocenter Human Embryonic Stem Cells (HESC) Product Introduction7.18.4 TATAA Biocenter Response to COVID-19 and Related Developments7.19 UK Stem Cell Bank7.19.1 UK Stem Cell Bank Business Overview7.19.2 UK Stem Cell Bank Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.19.3 UK Stem Cell Bank Human Embryonic Stem Cells (HESC) Product Introduction7.19.4 UK Stem Cell Bank Response to COVID-19 and Related Developments7.20 ViaCyte7.20.1 ViaCyte Business Overview7.20.2 ViaCyte Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.20.3 ViaCyte Human Embryonic Stem Cells (HESC) Product Introduction7.20.4 ViaCyte Response to COVID-19 and Related Developments7.21 Vitrolife7.21.1 Vitrolife Business Overview7.21.2 Vitrolife Human Embryonic Stem Cells (HESC) Quarterly Production and Revenue, 20207.21.3 Vitrolife Human Embryonic Stem Cells (HESC) Product Introduction7.21.4 Vitrolife Response to COVID-19 and Related Developments 8 Supply Chain and Sales Channels Analysis8.1 Human Embryonic Stem Cells (HESC) Supply Chain Analysis8.1.1 Human Embryonic Stem Cells (HESC) Supply Chain Analysis8.1.2 Covid-19 Impact on Human Embryonic Stem Cells (HESC) Supply Chain8.2 Distribution Channels Analysis8.2.1 Human Embryonic Stem Cells (HESC) Distribution Channels8.2.2 Covid-19 Impact on Human Embryonic Stem Cells (HESC) Distribution Channels8.2.3 Human Embryonic Stem Cells (HESC) Distributors8.3 Human Embryonic Stem Cells (HESC) Customers 9 Key Findings 10 Appendix10.1 About Us10.2 Disclaimer

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Human Embryonic Stem Cells (HESC) Market 2020 Global Share, Growth, Size, Opportunities, Trends, Regional Overview, Leading Company Analysis, And Key...

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Menopausal women taking hormone replacement therapy may have increased protection from Covid-19 – Telegraph.co.uk

Posted: May 12, 2020 at 7:45 pm

Menopausal women taking hormone replacement therapy (HRT) may have increased protection from Covid-19, scientists suspect.

Research led by King's College and NHS England is expected to establish within weeks why men have been more likely to fall seriously ill.

Questions assessing the potential protective effects of hormonal therapies, such as HRT or the pill, are being added to the Covid Symptom Study.

The app, which now tracks more than three million people across the UK, is aiming to develop a clearer picture after researchers in Wuhan, China, found women with lower levels of oestrogen typically suffered worse effects.

Dr Louise Newson, an advisor to NHS England, GP and menopause specialist, said the information could be particularly important for menopausal key workers considering whether to take HRT.

"We're seeing all the time that men are more likely to succumb to Covid, sadly, and more likely to go into intensive care," she said.

"Women have this ability to fight viruses a lot more efficiently and the cells that fight infection actually have oestrogen receptors on them so this means they respond to oestrogen and oestrogen can actually reprogramme these cells, make them more effective and also increase their number."

She described the research as "really exciting" because "if there is some protection (from oestrogen), it means that women who are menopausal who take HRT - which we know has more benefits than risks for the majority of women - might be able to have some protection".

"For me it's a really important question that we will hopefully have answered in the next couple of weeks. Not fully answered, but it will give some more understanding which is what we need."

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Student group works to improve trans, nonbinary inclusion – GW Hatchet

Posted: May 12, 2020 at 7:45 pm

One year in, leaders of a student group dedicated to community support for transgender and nonbinary students hosted almost a dozen events in collaboration with multicultural groups on campus.

Transgender and Non-binary Students of GW, a student organization formed last April as a supportive space for trans and nonbinary students, collaborated with more than 10 other organizations to educate students on issues important to the community like hormone replacement therapy. Executive board members said they plan to build on their first years efforts by keeping all of their events annual and expanding this years Transgender Awareness Week into a two-week LGBTQ celebration.

Junior Aedy Miller, the organizations current director of marketing and public relations and president-elect, said TNBS members were key leaders in facilitating social and educational events for Transgender Awareness Week in mid-November. Miller said the group planned educational and speaker events aimed at creating an inclusionary space for students of all identities, like a workshop with Students Against Sexual Assault about sexual assault and survivorship in the trans community.

Trans Awareness Week this year encompassed 15 events intended to empower transgender and nonbinary students and educate students about the community and issues affecting it. Student leaders said the weeks events, like a spoken word mic night celebrating trans artists, will happen again at Septembers LGBTQ celebration, which will also feature a mini-Pride event after Junes Pride festival was canceled.

The way that we sought to build community was by thinking about those who werent in the rooms when we were planning meetings, Miller said. Always thinking about who can we work with too, like different organizations, different University departments, who can be worked with to create a welcoming and affirming space for students of all identities.

Miller said the organization expanded its outreach into the D.C. community during Transgender Awareness week through a sticker fundraiser with the Organization of Latino American Students, which raised more than $700 for Casa Ruby the only D.C. organization providing direct services, like housing, for low- or no-income queer individuals.

The organization was founded to create a space dedicated specifically for trans and nonbinary students with a dual focus on empowering the community on campus, and also working in the queer community in D.C and not just being a social organization, but also an advocacy organization, they said.

Miller said the organization had planned a postcard campaign directed at state legislatures enacting legislation blocking transgender youth from accessing hormones or participating in sports for International Transgender Day of Visibility on March 31 before students were sent home for the semester because of the COVID-19 outbreak.

After the event was canceled amid the pandemic, TNBS members decided to use Discord, a virtual chat website similar to GroupMe, to allow students to continue communicating with each other and to offer support to each other after moving back home.

Within the community there are some folks who just dont even have a home to go back to, Miller said. On the flip side, if folks have a place to go back to, people either have to go back in the closet, are put into toxic or even like emotionally abusive situations where theyre constantly misgendered or dont feel affirmed in their home and just not safe in their home.

Harvey Tate, the groups incoming vice president, said student leaders partnered with the Multicultural Student Services Centers LGBTQIA Resource Center to augment resources available to students, like chest binders for students transitioning, as part of their goal to advocate for greater representation of trans and nonbinary students.

Tate said members have also met with Student Association and housing officials to discuss University policies about changing ones name and about housing that does not represent trans and nonbinary students. He said the housing department currently assigns students rooms based on sex instead of gender, creating problematic situations for students who identify as gender-neutral or transgender who are then forced to chose a gender or are stuck in potentially harmful roommate situations.

Id rather fix the system than keep trying to Band-Aid patch it, Tate said. So the end goal is to fix the system. But thats a long-term goal that we cant necessarily get done in our first year, because we have to build those avenues of trust and work toward them.

Tate said the organization partnered with the Division for Student Affairs in the spring to run two Engagement in Leadership Seminars, sessions all student organizations are required to attend aimed at advancing student leadership. He said the sessions walked students through common misconceptions on transitioning and answered questions students may otherwise have been uncomfortable asking outside of the workshop.

A part of our goal as an organization is to educate as well as advocate, so the ELS sessions were an important part of that, Tate said.

Freshman Sophia Packer, TNBSs treasurer, said the organization earned an Excellence in Diversity award in April from DSA for demonstrating a significant commitment to diversity and inclusive excellence throughout the year. Packer said the organization has worked to include students of varying perspectives in events held throughout the year, like Transgiving, to build an inclusive space on campus.

It was really a way to recognize how a lot of us dont necessarily have the best home lives and a place for essentially a found family to come together and eat this delicious, enormous meal and just spend time feeling safe and comfortable, Packer said.

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The Economic Impact of Coronavirus on Hormone Replacement Therapy Market: Business Opportunities, Current Trends and Industry Analysis by 2018 to 2028…

Posted: May 12, 2020 at 7:45 pm

The presented market report on the global Hormone Replacement Therapy market published by Fact.MR is a comprehensive analysis of the leading parameters that are likely to determine the growth of the Hormone Replacement Therapy market in the forthcoming decade. Further, the study dives in deep to investigate the micro and macro-economic factors that are projected to influence the global scenario of the Hormone Replacement Therapy market during the forecast period (2019-2029).

The market study reveals that the Hormone Replacement Therapy market is expected to grow at a CAGR of ~XX% and reach a value of ~USXX by the end of 2029. The report examines the current trends, growth opportunities, restraints, and market drivers that are projected to influence the overall dynamics of the Hormone Replacement Therapy market in the assessment period. The market study predicts the course of the global Hormone Replacement Therapy market post the COVID-19 pandemic and offers resourceful insights to market players pertaining to their business continuity strategies and more.

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Hormone Replacement Therapy Market Segmentation

The report bifurcates the Hormone Replacement Therapy market into multiple segments to provide a clear picture of the Hormone Replacement Therapy market at a granular level. The key segments covered in the report include region, product type, application, and more.

Competitive Landscape

The report on hormone replacement therapy market offers intelligence on key participants in the hormone replacement therapy market. The key companies involved in the formulation of hormone replacement therapy products are thoroughly assessed and profiled in the report. Various facets of competition including SWOT analysis, product portfolio analysis, drug developments and innovations, strategies and key financials are covered. Key companies profiled in the report include Novartis AG, Novo Nordisk A/S, Teva Pharmaceuticals, Mylan N.V and Pfizer Inc.

Major companies in the hormone replacement therapy market are concentrating on expanding their current product portfolio. New hormone replacement therapy formulations being the core focus, companies are carrying out trials and gain FDA approvals. For instance, Novartis AGs research and development department delivered 6 critical FDA breakthrough therapy designations and 16 submissions in 2017. In May 2017, Novartis AG announced U.S. FDAs approval for its hormone replacement therapy tablets for hormone receptor positive and metastatic breast cancer treatment in postmenopausal women.

In February 2018, Novo Nordisk A/S concluded main phase of REAL 1 the pivotal phase 3 trial along with somapacitan, a long-acting growth hormone to treat adults with growth hormone deficiency.

Teva Pharmaceuticals Industries Ltd. introduced Vagifem in 2017 for the treatment of atrophic vaginitis. In January 2018, the company launched Estrace cream to treat moderate and severe symptoms of vaginal and vulgar atrophy occurring due to menopause. Likewise, Mylan N.V expanded its US portfolio in the womens healthcare range with U.S. FDA approval for Estradiol Vaginal Cream to treat vaginal atrophy.

Private equity firms are focused on acquiring emerging participants that are involved in drug delivery systems in the hormone replacement therapy space. For instance, Riverside Company has acquired DoseLogix in a bid to provide innovative dosing dispensers for ensuring accurate dosing medications of hormone replacement therapy and other conditions.

Click to know more on competitive scenario in the hormone replacement therapy market to understand key strategies of market participants

Definition

Hormone replacement therapy, also referred to as menopausal hormone therapy, is used to treat various symptoms related to menopause among women. Hormone replacement therapy replaces hormones that are low in level as women near menopause. There are various types of hormone replacement therapy such as estrogen hormone replacement therapy, thyroid hormone replacement therapy and growth hormone replacement therapy.

About the Report

The report on hormone replacement therapy market provides incisive insights on all aspects influencing growth in demand for hormone replacement therapy worldwide. The report provides a thorough analysis on demand of hormone replacement therapy across key regions in the globe along with sales of various hormone replacement therapy products.

Key drivers, challenges, trends and opportunities shaping the growth of the hormone replacement therapy market are also covered in the hormone replacement therapy market report. The hormone replacement therapy market report provides historical data assessment on use of hormone replacement therapy, current hormone replacement therapy scenario and future demand of hormone replacement therapy. The forecast projections provided cover a timeline of 10 years (2018-2028).

Market Structure

The hormone replacement therapy market is segmented in detail to cover every angle of the hormone replacement therapy space. The hormone replacement therapy market has been segmented on the basis of product type, by dosage form, by indication, by distribution channel and by region.

Various hormone replacement therapy products such as estrogen hormone replacement therapy, thyroid hormone replacement therapy and growth hormone replacement therapy is covered. By dosage form, hormone replacement therapy market is segmented into tablets, patches, injections, implants and creams. By indications, hormone replacement therapy market is categorized into menopause, osteoporosis, thyroid and growth hormone deficiency. By distribution channel, it is segmented by hospital pharmacies, clinics, retail pharmacies and online pharmacies.

The hormone replacement therapy market is assessed across key regions such as North America, Latin America, Europe, Asia Pacific excluding Japan (APEJ), Middle East and Africa (MEA) and Japan.

Additional Questions Answered

Apart from key findings mentioned above, the hormone replacement therapy market report also answers additional questions such as:

Research Methodology

The hormone replacement therapy market is drafted using a unique research methodology comprising of a combination of secondary and primary research methodologies. The data gleaned from primary and secondary research is assessed along with information from external sources. All the statistics are compiled using triangulation method to gain highly accurate projections on hormone replacement therapy market.

Request methodology on hormone replacement therapy market report.

The growth projection of each of these segments and sub-segments is accurately tracked in the report along with east-to-understand graphs and tables. Further, the market share, size, value, and Y-o-Y growth of the Hormone Replacement Therapy market segments are included in the report.

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Essential Takeaways from the Hormone Replacement Therapy Market Report

Important queries related to the Hormone Replacement Therapy market addressed in the report:

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Fluctuating hormones can wreak havoc on your skin health: Know how to deal with it – TheHealthSite

Posted: May 12, 2020 at 7:45 pm

Beauty is not just skin deep. Your hormones play a big role in your external beauty too. Any abnormalities in your hormones can wreak havoc on your skin health. There come many phases in a womans life when there may be disruptions in hormones. Moreover, many diseases like thyroid, which are more common in women, also cause these disruptions. But there is nothing to worry about here. You can easily deal with this if you make a few changes in your life. You dont have to undergo expensive salon treatments or therapies, nor do you have to go in for any medical treatment. But before attempting to handle these conditions on your own, you need to know what exactly hormones are. These are nothing but chemical messengers secreted by glands. It facilitates many activities in your body including growth and development, metabolism, mood and sexual function. Some of the common hormones in your body are thyroid, cortisol, insulin, estrogen, testosterone and progesterone. Also Read - Skincare tips: Why you should exfoliate your skin and how to do it at home

According to researchers at UT Dell Medical School and Ascension Seton in Austin, Texas, your hormones dont just control how you feel. They can have an impact on the health of your skin, too. Some hormonal disorders manifest themselves in the skin and hair too. If your body is deficient in thyroid hormone, a condition called hypothyroidism, you may experience dry skin among other things. On the other hand, over production of the androgen hormone can make your skin excessively oily. During menopause, when a womans estrogen levels go down, she may experience dry and itchy skin. These are just a few examples. Also Read - Eat your sunscreen to protect your skin from the inside out: 6 foods that have SPF qualities

Let us take a look at how hormones can affect your skin at different stages of your life and how to deal with it. Also Read - Five worst enemies of your skin and how to combat them

This is the time when your body increases the production of both estrogen and testosterone. This results in excess sebum production and this makes your skin very oily. Outbreak of hormonal acne is very common during this stage in life.

How to handle this: Wash your face frequently and avoid using heavy facial creams. If the outbreak is too severe, consult a doctor. There are many topical ointments that can help. If you are a woman, your doctor may sometimes recommend hormonal birth control pills. You can also try out some home remedies to get rid of this problem. Apply sandalwood and turmeric paste or wash your face with lemon water. This will help to some extent.

When you are pregnant, your body produces excess estrogen. This can cause your skin to change to a darker tone. Some women also experience discolouration on their facial skin. This is called melasma.

How to handle this: Avoid sun exposure. You skin becomes extremely sensitive during this time. If you have to go out during the day, use a good sunscreen after consulting your doctor. Maintain a daily skin care ritual and stay hydrated. Follow a healthy diet that includes a lot of fresh fruits and vegetables. Drink enough water and do some moderate exercise. This will make your skin radiant.

This is the phase of life where your body stops the production of estrogen. As a result, your skin loses its elasticity and you start noticing fine lines and wrinkles. You may also experience dry skin around this time.

How to handle this: If you consult your doctor, he may recommend hormone replacement therapy (HRT) or prescribe bioidentical hormones (BHT). But you can also handle this on your own by eating properly and keeping your skin moisturized and hydrated. Sleep well at night and avoid stress for a radiant skin. Avoid alcohol and smoking and exercise. All this will make your skin glow despite your hormones going haywire.

Published : May 12, 2020 5:14 pm

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Acer Therapeutics to Develop Emetine as Potential COVID-19 Treatment in Collaboration with National Center for Advancing Translational Sciences, One…

Posted: May 12, 2020 at 7:45 pm

Targeting Q3 2020 initiation of an adaptive Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients, following IND submission and clearance

Acer to host conference call and webcast on Monday, May 11 at 5:30 pm Eastern Time

NEWTON, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of the National Institutes of Health (NIH), to develop emetine hydrochloride as a potential treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus. Under the terms of the agreement, Acer and NCATS will collaborate to accelerate the clinical development of emetine, a broad-acting and potent antiviral according to various preclinical and clinical studies.

Acer is in ongoing discussion with the Division of Antivirals (DAV) at the FDA after receiving its initial written responses to the Companys pre-Investigational New Drug (pre-IND) package. Acer is working toward an IND submission in mid-2020 and targeting clinical trial initiation in the third quarter of 2020, subject to additional capital. The Company has proposed an adaptive design Phase 2/3 randomized, blinded, placebo-controlled multi-center trial to evaluate the safety and antiviral activity of emetine in high-risk, symptomatic adult patients with confirmed COVID-19 infection not requiring hospitalization. The trial objectives as planned are to determine the safety and efficacy of emetine via clinical status at a specific timepoint in addition to disease resolution.

Acer is concurrently pursuing several financing options, including federally-funded research and grants, to support emetine development. For example, the Biomedical Advanced Research and Development Authority (BARDA) invited the Company to present the emetine development program at the BARDA CoronaWatch meeting on May 7, 2020. BARDA CoronaWatch is a funding program providing government support for selected coronavirus projects. While Acer plans to advance emetine through IND submission, initiation of the clinical trial of emetine is contingent on the timely availability of additional capital to fund this program.

Emetine will be delivered as a sterile subcutaneous injection. Acer will oversee the contract synthesis and manufacturing of emetine for clinical development and potential commercialization.

We are very pleased to be selected by NCATS and look forward to collaborating on the development of emetine, a broad-acting and potent antiviral identified by NCATS as their best preclinical opportunity for further clinical development for the treatment of COVID-19, said Chris Schelling, CEO and Founder of Acer. With a collaboration agreement in place, ongoing discussions with the FDA toward IND submission, and several potentially non-dilutive funding sources being pursued, we believe we are well-positioned to advance the clinical development of emetine.

Conference Call and Webcast DetailsInterested parties can access the live call and webcast on Monday, May 11, 2020, at 5:30 pm Eastern Time (2:30 pm Pacific Time) from the Investors section of Acers website or directly athttp://public.viavid.com/index.php?id=139741. Participants can also access the call by dialing 800-458-4148 (US Toll Free) or 1-720-543-0206 (International Toll Number) and providing the Conference ID 8855853. A replay of the call will also be available under the Investors section of Acers website.

About Emetine HydrochlorideAcer and NCATS are working together to develop emetine for the treatment of patients with COVID-19, the disease caused by the SARS-CoV-2 virus. Emetine is an active pharmaceutical ingredient of syrup of ipecac, given orally to induce emesis, and has also been formulated as an injectable to treat thousands of individuals with amebiasis. Several independent in vitro studies have demonstrated nanomolar potency against both DNA and RNA-replicating viruses, including Zika virus, Ebola virus1, Rabies Lyssavirus, human cytomegalovirus, human immunodeficiency virus 1, influenza A virus, Rift Valley fever virus, echovirus 1, human metapneumovirus, and herpes simplex virus type 22. Clinically, emetine has been used to treat approximately 700 patients (including pediatrics) with viral hepatitis3 and varicella-zoster virus4. Additionally, emetine is a potent inhibitor of multiple genetically-distinct coronaviruses and demonstrated in vitro the strongest anti-coronavirus activity in one study that screened and identified approved compounds with broad-spectrum efficacy against the replication of four coronaviruses5 and specifically against SARS-CoV-2.6

Acer intends to initially seek FDA approval to market emetine in the U.S. using a regulatory pathway established under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act that allows applicants to rely at least in part on third party data for approval. The Company intends to rely in part on the existing preclinical and clinical safety data for emetine, while supplementing with the COVID-19 safety and efficacy data to be generated in the Phase 2/3 trial as well as chemistry, manufacturing and controls information. If the Phase 2/3 trial is completed successfully, following IND submission and clearance, Acer anticipates submitting to the FDA the 505(b)(2) NDA for emetine for the treatment of COVID-19. The potential initiation of the Phase 2/3 trial, its conduct and completion and NDA submission are subject to the Companys ability to generate sufficient capital resources to fund this program. Emetine is an investigational drug for COVID-19 and is not currently FDA approved for any indication.

About the National Center for Advancing Translational SciencesThe National Center for Advancing Translational Sciences (NCATS) one of 27 Institutes and Centers at the National Institutes of Health (NIH) was established to transform the translational process so that new treatments and cures for disease can be delivered to patients faster. Its focus is to advance the science of translation, which is the process of turning observations into interventions to improve health. NCATS collaborates with researchers, the public and other stakeholder groups to design new approaches and technologies that ultimately will deliver more treatments to more people more quickly.

About Acer Therapeutics Inc.Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acers pipeline includes four clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; EDSIVO (celiprolol), for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate), for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant, for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. Each of Acers product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. For more information, visit http://www.acertx.com.

References

Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund the emetine program; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on managements current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of managements attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Investor Contact:Hans VitzthumLifeSci AdvisorsPh: 617-430-7578hans@lifesciadvisors.com

Jim DeNikeAcer Therapeutics Inc.Ph: 844-902-6100jdenike@acertx.com

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Impact of COVID-19 Hormone Replacement Therapy (HRT) Market Industry Survey 2020-2026 Abbott Laboratories, Novartis, Pfizer, Mylan Laboratories – NJ…

Posted: May 12, 2020 at 7:45 pm

Heres recently issued report on the Global Hormone Replacement Therapy (HRT) Market that allows you to offer a brief analysis of the market size, demand, supply chain, distribution channels, futuristic trends, market growth elements and so on. It offers a comprehensive analysis of assorted business aspects like global Hormone Replacement Therapy (HRT) market trends, recent technological advancements, market shares, size and new innovations. What is more, this analytical knowledge has been compiled through knowledge searching techniques like primary and secondary analysis for Hormone Replacement Therapy (HRT) industry. Moreover, an professional team of researchers throws lightweight on numerous static additionally as dynamic aspects of the worldwide Hormone Replacement Therapy (HRT) market.

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Global Hormone Replacement Therapy (HRT) market competition by prime manufacturers, with Hormone Replacement Therapy (HRT) sales volume, value (USD/Unit), revenue (Million USD) and market share for each manufacturer. The report provides an in-depth analysis of the worldwide Hormone Replacement Therapy (HRT) Market progressing to cut back time to plug for products and services, cut back operational value, improve accuracy and operational performance. Besides this, the report elaborates crucial aspects such as fresh product establishment, greater expenditure in R&D and increasing demand in the manufacturing differentiable growth opportunities in the Hormone Replacement Therapy (HRT) Market globally.

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The complete profile of the manufacturers are mentioned. And so the capability, production, price, revenue, cost, gross, margin of profit, sales volume, sales revenue, consumption, rate of growth, import and export, future strategies and therefore the technological developments that they are creating are also enclosed among the report. The historical knowledge and forecast knowledge from 2020 to 2026.

Leading companies reviewed in the Hormone Replacement Therapy (HRT) report are:

Abbott LaboratoriesNovartisPfizerMylan LaboratoriesMerck& Co.AmgenNovo NordiskBayerEli LilyWyethGenentech

The Hormone Replacement Therapy (HRT) Market report is segmented into following categories:

The product segment of the report offers product market information such as demand, supply and market value of the product.

The application of product in terms of USD value is represented in numerical and graphical format for all the major regional markets.The Hormone Replacement Therapy (HRT) market report is segmented into Type by following categories;OralParenteralTransdermalOthers

The Hormone Replacement Therapy (HRT) market report is segmented into Application by following categories;MenopauseHypothyroidismMale HypogonadismGrowth Hormone DeficiencyOthers

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The report provides substantial knowledge relating to the market share that every one in every of these firms presently garner across this business, in tandem with the market share that they are expected to amass by the highest of the forecast period. Also, the report elaborates on details regarding the products manufactured by every of these companies, that may facilitate new entrants and outstanding stakeholders work on their competition and strategy portfolios. To not mention, their decision-making method is vulnerable to get easier on account of the actual fact that the Hormone Replacement Therapy (HRT) System market report additionally enumerates a gist of the products value trends and so the profit margins of each firm among the industry.

This will enable the readers to focus on Hormone Replacement Therapy (HRT) market product specifications, current competitive manufacturers in Hormone Replacement Therapy (HRT) market and also the market revenue with gain. Worldwide Industry Analyze Hormone Replacement Therapy (HRT) Market by competitive manufacturers, regions and applications of Hormone Replacement Therapy (HRT) market, forecast up to 2026. This report analyses the scope of Hormone Replacement Therapy (HRT) market. This will be achieved by Hormone Replacement Therapy (HRT) previous historical information, analysing qualitative insights info, demonstrable projections regarding global Hormone Replacement Therapy (HRT) market size.

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Impact of COVID-19 Hormone Replacement Therapy (HRT) Market Industry Survey 2020-2026 Abbott Laboratories, Novartis, Pfizer, Mylan Laboratories - NJ...

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