Sept. 23, 2025 -- Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) today announced the Company will be presenting an update on its application for Orphan Drug status to the U.S. Food and Drug Administration (FDA) for HemaXellerate. This therapy is anticipated being used in treating aplastic anemia. Additionally the Company anticipates HemaXellerate may be used in addressing the side effects of Chemotherapy, a market of several billions of dollars. The Company’s Chairman and CEO, Dr.

Sept. 22, 2025 -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025. The presentation will provide detailed efficacy and safety data from the PIK3CA wild-type cohort of the VI

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 -- 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 -- 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

ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients Sept. 17, 2025 -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or th

Sept. 17, 2025 -- The world’s first therapeutic drug to be equipped with NovalGen’s pioneering AutoRegulation (AR) technology has been approved for evaluation in the clinic by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA). NVG-222, a next-generation, AutoRegulating T cell engager has been developed to increase the safety and durability of immunotherapies; and following confirmation of Clinical Trial Authorisation (CTA) by the MHRA, it is set to begin clinical evaluation l