Sept. 22, 2025 -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS). A total of 234 patients have been randomized across two treatment arms at multiple clinical sites in the United Stat

evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in post-CDK inhibitor setting, compared with standard of care plus everolimus The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed evERA is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen rec

Sept. 22, 2025 -- Starpharma , an innovative Australian biotechnology company, today announced the signing of a collaboration and license agreement with Genentech, a member of the Roche Group, to develop potential cancer therapies that leverage Starpharma’s proprietary DEP® drug delivery technology. Starpharma will receive an upfront payment of USD $5.5 million (~AUD $8.3 million), and is eligible for development, commercial, and net sales milestones of up to USD $564 million (~AUD $855 millio

Sept. 22, 2025 -- Yatiri Bio Inc. today announced it has received a grant from the Gates Foundation to launch a one-year project, Proteomics Interoperability, aimed at improving how large-scale proteomics data can be integrated and applied to global health challenges. Proteomics, the large-scale study of proteins, has emerged as a cornerstone of modern drug discovery, driving the search for new drug targets, early detection biomarkers, and measures of treatment efficacy. However, the field fac

Sept. 22, 2025 -- CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Sirius Therapeutics, a clinical stage biotech company developing innovative small interfering RNA (siRNA) therapies for global markets, today announced that the first patient has been dosed in a Phase 2 clinical trial of SRSD107, a next-generation, long-acting Factor XI (FXI) siRNA for the prevention of venous thromboembolism (VTE) in

Sept. 22, 2025 -- Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval

FDA grants Priority Review to idebenone for Leber Hereditary Optic Neuropathy (LHON), a disease for which there are no existing approved treatments in the U.S.; action date of February 28, 2026 People living with LHON suffer from rapid and severe loss of central vision due to mitochondrial dysfunction of retinal ganglion cells.1 Idebenone has the potential to be the first and only clinically proven short-chain benzoquinone, designed to target the underlying cause of LHON, mitochondrial dysfuncti

Sept. 19, 2025 -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting. The study demonstrated that nimacimab was safe, well-tolerated, and e

Sept. 19, 2025 -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia were updated to include revumenib as a category 2A recommendation for relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation (mNPM1).1 The update was based on positive pivota

Sept. 18, 2025 -- BioCardia®, Inc. [NASDAQ:BCDA] (“BioCardia” or the “Company”), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the pricing of a public offering of an aggregate of 4,800,000 shares of its common stock and short-term warrants to purchase up to 4,800,000 shares of common stock, at a combined public offering price of $1.25 per share and accompanying short-term warrant. The short-term warrants will ha