Exelixis and Bristol-Myers Squibb sNDA and sBLA Accepted by the FDA Exelixis (EXEL) and Bristol-Myers Squibb (

Celldex Therapeutics After an expected resurrection, Celldex Therapeutics (CLDX) stock recovered and went as high as over $19 from less than $2 after an exaggerated selloff caused by  investors following the failure to treat the still untreatable glioblastoma multiforme brain cancer. Today Celldex announced that enrollment has opened, in its randomized, double-blind Phase 1b study of CDX-0159 in patients with . . . This content …

Compugen New Addition, Dr. Nils Lonberg, PhD. Compugen (CGEN) announced the addition of Nils Lonberg, Ph.D., to its Scientific Advisory Board (SAB). Dr. Lonberg is a pioneer in the field of immuno-oncology and has more than 30 years of experience in the biopharmaceutical industry. Concurrently, Charles (Chuck) Drake, M.D., Ph.D. will be stepping down from Compugen’s . . . This content is for paid subscribers. …

Solid Biosciences Clinical Hold on IGNITE DMD is Lifted by the FDA Solid Biosciences (SLDB) - a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced that the U.S. FDA has lifted the clinical hold placed on the Company’s IGNITE DMD Phase 1/2 clinical trial. The FDA had requested further manufacturing information, updated safety and efficacy . . . This content …

News from Cassava Sciences, Moderna and Sorrento Therapeutics  Cassava Sciences  Cassava Sciences (SAVA) announced that clinical results of its Phase 2b study of sumifilam have been selected as a late-breaking oral presentation by the 13th international conference on Clinical Trials on Alzheimer’s Disease (CTAD). What is CTAD? CTAD is a prestigious annual conference focused on Alzheimer’s . . . This content is for paid subscribers. …

Crispr Therapeutics and Vertex Pharmaceuticals CTX001 Granted PRIME Designation by the EMA CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (

Seattle Genetics Two New Strategic Oncology Collaborations with Merck Seattle Genetics (SGEN) and Merck (

Cassava Sciences Study Results of Sumifilam for Alzheimer's Disease Prohost is happy to inform our subscribers that our positive opinion about Cassava Sciences' product created and developed for Alzheimer’s disease happens to be right. Cassava Sciences (SAVA) announced today the final results of a Phase 2b study with its lead drug candidate, sumifilam, in Alzheimer’s disease. The results . . . This content is for paid …

Compugen Announced Encouraging News from Its Phase 1/2 Study of COM701 Compugen (CGEN) announced that the first patient has been dosed in the Phase 1/2 study of the triple combination of COM701 - Compugen’s first-in-class anti-PVRIG antibody, with Bristol Myers Squibb’s  (

Exelixis Announces Submission of sNDA to US FDA for CABOMETYX® Exelixis (EXEL) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). From Exelixis According to Gisela Schwab, M.D., President, Product Development and Medical . . . This content is for paid subscribers. Please click here …

Gilead Sciences Was Issued a CLR from the FDA for Filgotinib Gilead Sciences (GILD) is in receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Regenxbio Positive Data for RGX-314 Regenxbio (RGNX) reported positive one-year data from patients in Cohorts 4 and 5 from Phase I/IIa trial of RGX-314 for wet age-related macular degeneration (wet AMD). Regenxbio plans to initiate a pivotal program for the subretinal delivery of the gene therapy RGX-314 in patients . . . This content is for paid subscribers. Please click here to subscribe or here to log …

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 …

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 …

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.

A Letter to Subscribers The complex brutal circumstances we are currently living in has made it imperative that we communicate with you so that you can understand how we at Prohost Biotech are acting in these difficult times. Current news announcing that the SARS-CoV-2 virus is infecting more, not fewer, people in many U.S. states and overseas. In the meantime, we are observing the tremendous …

Agenus Has Two Separate Press Releases In the First Press Release from Agenus: Agenus (AGEN) announced that it will be making a scientific presentation today on optimal anti-cancer combinations with Fc enhanced anti-CTLA-4, AGEN1181 at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting.  AGEN1181 - an Fc-engineered anti-CTLA-4 that has . . . This content is for paid subscribers. Please click here to …

Reata Pharmaceuticals Stock is Flying High Here is another example of why analysts can no longer use the same old measures to evaluate the biotechnology firms. They cannot continue to ignore the values of the firms’ technologies and very promising products. Very promising products are those that can treat diseases in patients who are condemned with a diagnosis. Today’s example is flying on the wings …

Curis Inc IND Application Cleared by the US FDA Curis Inc (CRIS) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody. Continue reading to learn about VISTA.  The clearance of the firm’s IND was important and considered an important . . . This content is for paid subscribers. Please click here …

Sonoma Pharmaceuticals and MicroSafe Group, Dubai Sonoma Pharmaceuticals (SNOA) develops stabilized hypochlorous acid (HOCl) products for a wide range of applications including: wound care, eye care and dermatological conditions. Together with MicroSafe Group, Dubai, announced the receipt of approval from Australia for Nanocyn® Disinfectant & Sanitizer, manufactured by Sonoma using its . . . This content is for paid subscribers. Please click here to subscribe or …