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 …
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 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 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 …
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 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 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 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 …
Vertex Pharmaceuticals Acquisition of Alpine Immune Sciences We start this posting by answering a question by savvy investors regarding Vertex Pharmaceuticals' (VRTX) decision to acquire Alpine Immune Sciences (
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 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 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 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 . . . …
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 …
Novo Nordisk in the NEWS Novo Nordisk (NVO) and Cardior Pharmaceuticals announced that Novo Nordisk agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 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 …
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, …
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