A significant, dose-dependent reduction in bone marrow lesion presence and area was observed for LEVI-04 compared with placebo in patients with osteoarthritis Changes in bone marrow lesion area were significantly correlated with changes in patient-reported symptoms including pain Further presentations detail LEVI-04 mechanism of action, functional outcomes and imaging screening exclusions LEVI-04 is a first-in-class novel biologic under development as non-addictive pain treatment Sept. 25, 202

Sept. 25, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), today announces it will advance its second asset, a fully human anti-IL-6 receptor (“IL-6R”) monoclonal antibody, TZLS-501. There has been heightened industry activity in the IL-6 pathway space, underscored by Novartis’ recent acquisition of Tourmaline Bio for approximately $1.4 billion. Tiziana will pursue non-dilutive funding strategies for the development of TZLS-501 while continuing to advance intrana

KYV-101 IIT data demonstrate promising clinical activity, including robust CAR T penetration into the central nervous system (CNS) and improved expanded disability status scale scores (EDSS) KYV-101 continues to demonstrate a tolerable safety profile, consistent with observations from the first 100 patients treated with KYV-1011 Encouraging early data of KYV-101 in multiple sclerosis highlights broader potential within neuroimmunology autoimmune diseases Sept. 24, 2025 -- Kyverna Therapeutics

~ 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