Author: Prohost

Vertex and TreeFrog Therapeutics Announced Licensing Agreement and Collaboration to Optimize Production of Vertex Cell Therapies for Type 1 Diabetes

Vertex Pharmaceuticals and TreeFrog Therapeutics in the NEWS Vertex Pharmaceuticals  (VRTX) and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog’s proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex’s cell therapies for Type 1 diabetes (T1D). TreeFrog and Vertex will collaborate to scale up TreeFrog’s process to produce and amplify cells for . . . This content is for paid …

Regeneron and Mammoth Biosciences Collaborate to Pursue Next-Generation CRISPR-Based Gene Editing for Multiple Diseases

Regeneron Pharmaceuticals and Mammoth Biosciences in the NEWS Regeneron Pharmaceuticals (REGN) and Mammoth Biosciences, Inc. announced a collaboration to research, develop and commercialize in vivo CRISPR-based gene editing therapies for multiple tissues and cell types. Regeneron develops adeno-associated viral vectors (AAVs) using antibody-based targeting to enhance delivery of genetic medicine payloads to specific tissues and cell types. Mammoth . . . This content is for paid …

The U.S. FDA Approved Immunity Bio’s ANKTIVA® for the Treatment of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Immunity Bio in the NEWS Immunity Bio (IBRX) - an immunotherapy company, announced that the U.S. FDA has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Immunity Bio . . . This content is for paid subscribers. Please click here to …

Cerevel Therapeutics Announces Positive Results for Tavapadon in Phase 3 Adjunctive Trial for Parkinson’s Disease

Cerevel Therapeutics in the NEWS Cerevel Therapeutics (CERE) announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as once a day treatment for Parkinson’s disease. The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa  in adults. The trial met its primary endpoint. Patients …

Vertex Pharmaceuticals Announces Advancements of Its Product Suzetrigine for Acute and Neuropathic Pain

Vertex Pharmaceuticals in the NEWS Vertex Pharmaceuticals (VRTX) announced advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades. Vertex’s product suzetrigine is an oral selective NaV1.8 pain signal inhibitor, which has been granted FDA Fast Track and Breakthrough Therapy Designations in moderate-to-severe . . . This …

Voyager Therapeutics: Demonstrating Productivity in Collaboration with Neurocrine to Advance Gene Therapies for Neurological Diseases

Voyager Therapeutics  Voyager Therapeutics (VYGR) is a biotech company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. The firm’s pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of Voyager programs are derived from its TRACERTM . . . This …

Syndax Pharmaceuticals: Positive Pediatric Data from Pivotal Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at ASPHO Plenary Session

Syndax Pharmaceuticals in the NEWS Yesterday, Syndax Pharmaceuticals (NASDAQ: SNDX) announced the presentation of positive data from the pivotal AUGMENT-101 trial in pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) treated with revumenib, a first-in-class menin inhibitor. The pediatric data was featured in . . . This content is for paid subscribers. Please click here to subscribe or …

Madrigal Pharmaceuticals Announces U.S. Availability of its Newly Approved Product Rezdiffra

Madrigal Pharmaceuticals in the NEWS Today, April 09, 2024, Madrigal Pharmaceuticals (MDGL) announced that its NASH MASH product Rezdiffra (resmetirom) is now available in the United States. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may . . …

BioStem Technologies’ Press Release and Conference Call Offered Encouraging News

BioStem Technologies Inc From Jason Matuszewski, CEO of BioStem Technologies (BSEM), who stated, “BioStem had an outstanding fourth quarter. Revenue reached $11.5 million, nearly 14 times higher than revenue of roughly $0.8 million for last year’s comparable quarter. The growth was driven by the successful commercial launch into the private office setting of AmnioWrap2, our innovative placental-derived allograft product designed to . . . This …

BioStem Technologies is Releasing its Fourth Quarter 2023 Financial Results Now

BioStem Technologies to Release Fourth Quarter Results BioStem Technologies (BSEM) is hosting a conference call and webcast today, April 1, 2024 at 4:30 PM ET. The call will include a discussion of fourth quarter 2023 financial results in addition to a corporate update. To access the call dial:  USA / International Toll. + 1(646) 307-1963.  USA – Toll-Free (800) 715 9871 BioStem . . . …

Verrica Pharmaceuticals Announced the FDA Granted YCANTHTM New Chemical Entity Status and Orange Book Listing

We are currently working to bring into the upcoming ProhostBiotech Letter some small clinical and commercial innovating firms that are challenging the Top-Tier firms that are currently generating billions of dollars in selling revenues.  These firms are developers of products for treating  type 2 diabetes, obesity and NASH diseases, in addition to clinical stage firms that are challenging the current developers of gene editing diseases …

Italfarmaco Received FDA Approval for Duvyzat™ for the Treatment of Duchenne Muscular Dystrophy

Italfarmaco in the NEWS  From Milan, Italy: Today, Italfarmaco announced that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat) – a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD) – a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood. From Italfarmaco Paolo Bettica, MD, PhD, Chief Medical Officer …

Illumina Stock Price Will Rebound With or Without This News

Illumina in the NEWS On March 21, 2024, we learned that the EU antitrust regulators suffered a blow as an adviser to Europe's top court said that they exceeded their powers when they blocked U.S. Illumina's (ILMN) $7.1 billion bid for merging with Grail.   In 2021,  the European Commission asserted a rarely used Article 22 to assess Illumina . . . This content is for …

Selecting New Small Biotech Firms for Investment

During a discussion with colleagues about the best way to select small and new biotechnology firms for investment purposes, we started our answer by stating that selecting small and new biotechnology firms for investments is extremely challenging. As a matter of fact, the choice of firms for investment cannot be guaranteed approval of the firms’ products based on early and mid clinical trials' promising results, …

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra for the Patients with NASH That Have Moderate to Advanced Liver Fibrosis

Madrigal Pharmaceuticals in the NEWS Yesterday, March 14, 2024 Madrigal Pharmaceuticals (MDGL) announced that the U.S. FDA has granted accelerated approval for the firm’s product Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The Approval for this . . . This content is for …

Today’s Bad, Bear Market and Cullinan Oncology Providing 2023 Accomplishments and Financial Results

The Market Today the Stock Market is bearish and most of the biotech stocks are down until the mid-day hour (around 2:30 PM).  Most of the time, the cause of a bearish market has nothing to do with the biotech the firms' accomplishments or incomes. As we keep reminding, we are living under devastating circumstances created mostly by us not by the biotechnology sciences, which …