~ Pivotal study met primary endpoint; high-dose AMT-130 demonstrated statistically significant 75% disease slowing at 36 months as measured by cUHDRS compared to a propensity score-matched external control ~ ~ High-dose AMT-130 also demonstrated statistically significant slowing of disease progression as measured by TFC, a key secondary endpoint, and favorable trends across additional clinical measures ~ ~ Mean cerebrospinal fluid NfL levels were below baseline at 36 months ~ ~ AMT-130 continued

Sept. 24, 2025 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's diseas

Pediatric dosing expected to begin in Q4 2025 Pivotal cohort expected to begin enrolling in Q1 2026 BLA submission anticipated in early 2028 Part A results demonstrated efficacy and safety; ATSN-201 on track to be first gene therapy and one-time treatment for XLRS Sept. 23, 2025 -- Atsena Therapeutics, a clinical-stage gene therapy company focused on using the life-changing power of genetic medicine to reverse or prevent blindness, today announced that dosing is complete in adults enrolled in

Aphaia’s lead formulation orchestrates a comprehensive hormonal response from nutrient-sensing cells with potential to modify the course of obesity and associated metabolic diseases. It is currently under evaluation in a Phase 2 trial in individuals with obesity, following positive Phase 2 trial data in patients with prediabete Sept. 23, 2025 -- Aphaia Pharma, a clinical-stage company developing precision-targeted drug formulations that harness endogenous enteroendocrine systems to treat obes

Clinically significant angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients Company plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026 Company to host webcast conference call today, September 24, 2025 at 8:30am ET Sept. 24, 2025 -- Palvella T

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