Cidara Therapeutics Cidara Therapeutics (CDTX) is using its proprietary Cloud break® platform to develop novel drug-Fc conjugate (DFC) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In . . . This content …
BridgeBio Pharma BridgeBio Pharma, Inc. is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. The Company was founded in 2015. Its team of experienced drug discoverers, developers and innovators is committed to applying advances in genetic medicine …
GSK US FDA Approval Yesterday, October 23, 2025, GSK plc (GSK) announced the United States Food and Drug Administration (FDA) has approved Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI
Roche in the NEWS Roche (RHHBY) announced Food and Drug Administration approval of Gazyva®/Gazyvaro®(obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, offering an . . . This …
Boehringer Ingelheim USFDA Approval Boehringer Ingelheim JASCAYD® (nerandomilast) tablets are approved by the U.S. FDA as an oral treatment for idiopathic pulmonary fibrosis (IPF) in adult patients. JASCAYD is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung …
Samsung and GRAIL Announce Strategic Collaboration to Bring GRAIL’s Galleri® Multi-Cancer Early Detection Test to Asia Today, October 16, 2025, Samsung C&T (SCT), Samsung Electronics (SEC), and GRAIL, Inc. (GRAL) announced signing a binding Letter of Intent for a strategic collaboration to bring GRAIL’s GalleriⓇ multi-cancer early detection (MCED) test to . . . This content is for paid subscribers. Please click here to subscribe or …
The Great Story from Regerneron Pharmaceuticals Regeneron Pharmaceuticals (REGN) announced updated data for the Company’s investigational gene therapy DB-OTO for profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were. The investigation has been published in The New England Journal of Medicine and presented during oral presentation at the annual American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) meeting. The latest results from the pivotal CHORD trial …
Akero Therapeutics Acquisition Agreement Today, October 9, 2025, Akero Therapeutics (AKRO) announced that it entered into a definitive agreement to be acquired by Novo Nordisk (
Neurizon Therapeutics in the NEWS Today October 6, 2025, from Melbourne, Australia: Neurizon Therapeutics Limited (ASX: NUZ & NUZOA), and U.S (ECQO.F), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the U.S. FDA has lifted the clinical hold on its lead investigational drug, NUZ-001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS …
Genmab in the NEWS Denmark; UTRECHT, The Netherlands; Today, Genmab (GMAB) and Merus (MRUS) announced that they entered into a transaction agreement pursuant to which Genmab . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
uniQure in the NEWS On September 24, 2025, uniQure N.V. (QURE) - a gene therapy company advancing transformative therapies for patients with severe medical needs, announced positive topline data from the pivotal Phase I/II study of AMT-130 for the treatment of Huntington’s disease. The study met its prespecified primary . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Important News from Grail Inc. and Intellia Therapeutics Grail Inc Press Realease GRAL to Present New Galleri® Data from More Than 32,000 Participants Across the PATHFINDER 2, SYMPLIFY and REFLECTION Studies at ESMO Congress 2025 and EDCC First PATHFINDER 2 Results Accepted as a Late-Breaking Presentation at the European Society for Medical Oncology (ESMO) Congress 2025; Results to be Submitted to FDA as Part of …
VectorY Therapeutics in the NEWS September 18, 2025 – VectorY Therapeutics, a biotechnology company developing innovative vectorized antibody therapies for the treatment of neurodegenerative diseases, and Shape Therapeutics Inc., a biotechnology company harnessing AI and RNA technologies to engineer next-generation genetic medicines, announced Today that they have entered into an option and license agreement. The Agreement The agreement grants VectorY an exclusive option to evaluate …
Lexicon Pharmaceuticals in the NEWS Yesterday, September 17, 2025, Lexicon Pharmaceuticals (LXRX) announced the presentation of clinical data from the company’s Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain (DPNP) at two medical meetings: “New Promise for Painful Diabetic Neuropathy: Results from recently finished clinical trials of Pilavapadin, an oral, non-opioid . . . This content …
Eli Lilly Eli Lilly and Company (LLY) today September 17, announced positive topline results from ACHIEVE-3, Phase 3 clinical trial evaluating the safety and efficacy of orforglipron compared to oral semaglutide, administered according to approved label instructions in 1,698 adults with type 2 diabetes inadequately controlled with metformin. The 52-week trial compared orforglipron (12 mg and 36 mg) to oral . . . This content is …
Jazz Pharmaceuticals On September 9, 2025, Jazz Pharmaceuticals plc (JAZZ) announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation. Modeyso was granted . . . This content is for paid subscribers. Please …
Xenon Pharmaceuticals A Company Treating Chronic Pain Xenon Pharmaceuticals (XENE) - a neuroscience-focused biopharmaceutical company dedicated to drug discovery, development, and commercialization of life-changing therapeutics for patients in need, announced equity inducement grants to seven new non-officer employees consisting of an aggregate of 55,300 share options. Xenon’s lead molecule, azetukalner, azetukalner - a novel, potent, selective Kv7 potassium channel opener in Phase . . . …
Alnylam Pharmaceuticals Press Release Alnylam Pharmaceuticals, Inc. (ALNY), the leading RNAi therapeutics company, announced today that it has commenced a private offering of $500 million aggregate principal amount of convertible senior notes due 2028 (the “notes”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). In connection with this offering …
Regeneron Pharmaceuticals Announcement Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months. Regeneron Pharmaceuticals, Inc. (REGN . . . This content …
Alkermes in the NEWS Today, Alkermes Inc., (ALKS) announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, (formerly ALKS 2680), is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 . . . This content is for paid subscribers. Please …
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