Month: April 2024

Akero Therapeutics Appoints Scott Gangloff as Chief Technology Officer

From Akero Therapeutics  Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics remarked, "I am delighted to welcome Scott Gangloff to Akero. His depth of experience leading drug manufacturing for both national and multi-national biopharmaceutical organizations enrich our company with an invaluable perspective during the late-stage clinical development of efruxifermin.  The entire leadership team looks forward to partnering with Scott to advance …

INmune Bio Inc. Update on Two Alzheimer Disease Patients Who Continued to Receive XPro Product

INmune Bio Press Release  INmune Bio (NASDAQ: INMB) is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three years under the Australian compassionate use program known as the Special Access Scheme (SAS).  Both patients, herein referred to as “Patient 1” and “Patient 2,” was …

U.S. FDA Approved Pfizer’s BEQVEZ™ – A One-Time Gene Therapy for Adults with Hemophilia B

 Pfizer Approval A one-time dose of the Pfizer product, BEQVEZ, has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds (range 0 to 19) after up to three years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients. Pfizer (PFE) announced today that . . . This content is for paid …

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 . . . …