Tag: SARS-CoV-2 (the virus that causes COVID-19)

Atea Pharmaceuticals: The U.S. FDA Granted Fast Track Designation to Bemnifosbuvir Oral Antiviral for COVID-19

Atea Pharmaceuticals Receives Fast Track Designation for Bemnifosbuvir Atea Pharmaceuticals (AVIR) announced that the U.S. FDA has granted Fast Track designation to its product bemnifosbuvir for the treatment of resistant COVID-19.   Bemnifosbuvir is an oral, direct acting antiviral drug candidate being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID . . . This content is for paid subscribers. …

Why Investors Have Enthusiasm for CureVac N.V.

CureVac N.V. in the News CureVac N.V. (CVAC) announced that after more than 10 years as a member of the CureVac management board and three years as CEO, Dr. Franz Haas will step down as CEO, effective March 31, 2023. Joining CureVac from Sanofi, on April 1, 2023, is Dr. Alexander Zehnder. CureVac is a biopharmaceutical firm developing a new class . . . This …

CureVac Lawsuit Against BioNTech and Subsidiaries, Seeking Fair Compensation for Infringement of Intellectual Property

CureVac N.V. Files Lawsuit Against BioNTech for Infringement  CureVac N.V. (CVAC), a company that develops therapeutics based on messenger ribonucleic acid (mRNA), has moved to assert its intellectual property rights that have been accumulated over more than two decades of pioneering work in mRNA technology. Technology that contributed to COVID-19 vaccine development. The Company acknowledged filing a lawsuit . . . This content is for …

Gilead Sciences: Remdesivir is the First and Only Approved Treatment for Pediatric Patients with COVID-19. See Also: Cassava Sciences

Gilead Sciences Receives sNDA from the FDA for Remdesivir for Pediatric Patients with COVID-19 Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury®, aka remdesivir, for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and . . . This content is for paid subscribers. …

Interesting News from PTC Therapeutics and Arcturus Therapeutics Holdings

Arcturus Therapeutics Holdings News Arcturus Therapeutics Holdings (ARCT) shared topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19. The ongoing Phase 1/2/3 registrational study, sponsored by Arcturus’ collaborator Vinbiocare Biotechnology Joint Stock Company – a member of Vingroup Joint Stock Company, enrolled over . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Our Plan as the Stock Market Continues to Plummet

The Stock Market Continues to Plummet Indeed, the Stock Market continues to decline, losing investors' profits.   Each time the Market plummets it takes with it promising firms' stocks but when the biotech stocks plummet new reasons are always claimed for the decline. Today's claimed reason for the deep losses is the tension between Russia and Ukraine, which, as it happens, is not the only …

Who Forgot About Enanta Pharmaceuticals?

Enanta Pharmaceuticals Expectations Expecting Dosing in a First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19 The Firm Completed Enrollment in RSVP, a Phase 2b Conducted Trial of EDP-938 in Adults With Community-Acquired Respiratory Syncytial Virus (RSV) Expects Topline Data in the Second Quarter of 2022 The Firm has Plans to Initiate a Phase 1 Study of EDP-323, …

The FDA Authorized Emergency Use of Pfizer Paxlovid Pills Against COVID-19

Pfizer Received Emergency Use Authorization from the FDA for Paxlovid Pills for COVID-19 Good news for Pfizer (PFE), the U.S. FDA announced it has authorized the emergency use of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 (the virus that cause COVID-19) viral testing …

Comprehensive Prohost Letter #448

Comprehensive Prohost Letter Issues Coronavirus Variant Omicron A lot has happened since the coronavirus variant Omicron was discovered in South Africa. After having been responsible for a severe plummeting of the stock market, Omicron boosted the market after being described by many scientists as fast spreading with different yet milder symptoms when compared to those caused by SARS-CoV-1, SARS-CoV-2 (the virus that causes COVID-19) and …

Arcturus Therapeutics Additional Updates from ARCT-154 and ARCT-165 Clinical Trials and More

Arcturus Therapeutics Holdings Arcturus Therapeutics Holdings (ARCT) is a clinical-stage mRNA medicines company of enabling technologies with an interesting pipeline of treatments and vaccines as well as other products for diseases that have yet to find treatments. Arcturus Therapeutics’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense . . . This …

AstraZeneca Granted FDA EUA for Long Acting Antibody Evusheld for Pre-Exposure Prophylaxis of Covid-19

AstraZeneca Long Acting Antibody Granted FDA EUA for COVID-19 Prevention AstraZeneca (AZN) product Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination received emergency use authorization (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with the first doses expected to become available very soon. The EUA for Evusheld was granted for . . . This content is for paid subscribers. Please click here …

The Omicron Variant and the Bizarre Stock Market Chaos

The Bizarre Assessment of Biotech Firms in the Stock Market The Clinical-Stage Biotechnology Firms  We are witnessing inexplicable evaluations of clinical-stage biotechnology companies. Bizarre is the best description of this group’s assessment which is based on incomes that do not exist in biotech firms that are yet to have approved and marketed products anywhere in the world. Unfortunately, the most impacted firms by the bizarre …

Merck and Ridgeback Biotherapeutics: U.S. Government to Purchase 1.4 M Additional Courses of Molnupiravir for COVID-19

U.S. Government to Purchase More of Merck and Ridgeback Biotherapeutics Molnupiravir for COVID-19 Merck (MRK) and Ridgeback Biotherapeutics announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir - an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or . . . This content is for paid …

Why Merck’s Stock Price Soared. See Also: Pulmotect Inhaled PUL-042 for Respiratory Symptoms of COVID-19 and Fujirebio Agreement with ADDF

Merck Stock Soared Great expectations for Merck (MRK) future growth and the future of novel treatments for patients with severe devastating and life-threatening diseases. Keytruda - Merck's cancer immunotherapy drug, has reached a milestone and molnupiravir - its COVID-19 pill, sales revenues are expected to generate $5 billion to $7 billion through 2022, subject to emergency use authorization, at the end of November 2021. The …

Don’t Miss the Enanta Pharmaceuticals Virtual Conference on October 19th – October 21st

Don’t Miss Enanta Pharmaceuticals Virtual Conference Enanta Pharmaceuticals (ENTA) – a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that new preclinical data for EDP-235 – its lead oral protease inhibitor, which is specifically designed for the treatment of COVID-19, will be presented at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)-World Health …

Atea Pharmaceuticals and Xenon Pharmaceuticals: Two Clinical-Stage Firms That Rallied Instead of Crashing Yesterday

Two Clinical-Stage Firms Rallied Yesterday On a day when the Stock Market was crushed, taking down with it shareholders’ money for no reason other than the self-serving untouchable agendas, two small biotechnology companies staged rallies. Atea Pharmaceuticals and Xenon Pharmaceuticals deserved the boosting of their stocks.   Atea Pharmaceuticals Atea Pharmaceuticals (AVIR) - a clinical-stage biopharmaceutical company, reported for the first time . . . …

Merck and Ridgeback Biotherapeutics Announced Successful Phase 3 Trial Results of Molnupiravir for Mild or Moderate COVID-19

Merck and Ridgeback Biotherapeutics COVID-19 News  Merck (MRK) and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801) - an investigational oral antiviral medicine, has significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized . . . This content is for paid subscribers. Please click here to subscribe or here to log in.