Inovio Inovio’s COVID-19 Vaccine INO-4800 Accomplished the Following: Durable antibody and T cell responses in rhesus macaques for 4 months. Long-term protection in non-human primates challenged with SARS-CoV-2 virus 13     weeks from vaccination. No other vaccine has demonstrated it. Reduced viral loads and faster viral clearance in macaques’ lungs and nasal passages as a result of a good Memory T and B cell …

Edesa Biotech Filed an IND for EB05 Edesa Biotech (EDSA), a clinical-stage biopharmaceutical company, has filed an investigational new drug (IND) application with the U.S. FDA for the initiation of a Phase 2/3 clinical study of its investigational drug EB05. Edesa has recently received expedited approval to begin the Phase 2/3 . . . This content is for paid subscribers. Please click here to subscribe or …

SARS-CoV-2 Virus Vaccines Moderna On Monday Moderna (MRNA) started its Phase 3 clinical trial on 30,000 people with its product mRNA-1273. Separately, in a press release Moderna announced a preclinical study evaluating its product mRNA-1273 has been published in The New England Journal of Medicine. This study . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gilead Sciences CAR T Cell Product Tecartus Gets FDA Approval The U.S. FDA approved Kite - Gilead Sciences (GILD) chimeric antigen receptor (CAR) T cell therapyTecartus™ (brexucabtagene autoleucel). Tecartus has become the first and the only approved CAR T cell therapy for adults with relapsed or refractory mantle cell lymphoma (MCL). The FDA approval of . . . This content is for paid subscribers. Please …

TCR2 Therapeutics Announcement TCR2 Therapeutics (TCRR) – a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for cancer, announced positive interim data from the first five patients treated in the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for mesothelin-expressing solid tumors. All five patients have demonstrated tumor regression including two RECIST unconfirmed partial responses (one of which remains subject to independent central …

Arbutus Biopharma and Moderna's Patent Challenge Arbutus Biopharma (ABUS) is a publicly-traded biopharmaceutical company dedicated to discovering and developing a cure for patients suffering from chronic hepatitis B infection. The stock has been in the Aggressive Table of the

People living with narcolepsy who develop cataplexy and excessive daytime sleepiness have a new treatment called Xywav, from Jazz Pharmaceuticals. Jazz Pharmaceuticals NEWS On July 21, 2020 the U.S. FDA approved Jazz Pharmaceuticals’ (JAZZ) product Xywav™ (calcium, magnesium, potassium and sodium oxybates) oral solution for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.  About Narcolepsy …

Firms' with COVID-19 Vaccines Stock Performance A look at the stock performance of the COVID-19 vaccine firms that have demonstrated early, promising and even good news regarding their prophylactic effect. The outcome was as follows:    Moderna (MRNA): was down over 12% after an analyst at J.P.Morgan downgraded the company to neutral from overweight, overvaluation . . . This content is for paid subscribers. Please …

Beyond the firms that are speeding towards bringing prophylactic vaccines against the COVID-19 infection into the clinic we have to consider the other firms that have been negatively affected by the virus pandemic; we expect them to rebound and surge when the virus loses its ability to kill. We decided to start with gene therapy companies that we believe have suffered from the delays of …

Alzheimer’s Disease Alzheimer’s Disease has proven very difficult to treat through many of the trials’ attempts by both small and large biotechnology and biopharmaceutical companies. Analysts and investors are skeptical about all promised successes in defeating this disease. However,  knowing that we are in the middle of a biological scientific revolution we are keeping our eyes and ears open each and every time a firm, …

Pfizer and BioNTech Vaccines Were Granted FDA Fast Track Designation Against SARS-CoV-2 (COVID-19) A large Phase 2b/3 safety and efficacy study may begin as early as July 2020 Pfizer (PFE) and BioNTech (

CRiSPR Therapeutics Rally  For those who wonder why CRiSPR Therapeutics (CRSP) is soaring we remind that they should have been expecting this rally and for it to be followed by its two sisters Intellia Therapeutics (

Corvus Pharmaceuticals: FDA Granted IND Application for COVID-19 Trial The United States FDA granted approval of Corvus Pharmaceuticals (CRVS) investigational new drug (IND) application for a COVID-19 trial. Corvus announced the beginning of the Phase 1 study that intends to enroll up to 30 patients. The . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #441 Biotechnology Companies’ Evaluations Are We Saying Goodbye to Common Sense? The SARS-CoV-2 Vaccines It is said that the difference between the SARS-CoV-2 coronavirus (COVID-19), which is causing the pandemic around the world we are currently suffering from, and other coronaviruses like SARS and/or MERS is that SARS-CoV-2 ability to replicate in the human bodies' respiratory system’s upper airways more than the others. …

Akero Therapeutics Today we posted good news from Akero Therapeutics (AKRO) under News & Comments. The news was about results from Phase 2a BALANCED . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Akero Therapeutics Efruxifermin Positive Results in NASH Akero Therapeutics (AKRO) results of a 16-week analysis of secondary and exploratory endpoints in Phase 2a BALANCED study of its product efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH) are beating everybody’s expectations, including Akero Therapeutics.    Of the 40 responders, the firm observed that 48% achieved at least a one-stage improvement in fibrosis without …