Oct. 28, 2025 -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the first participant has been randomized in the company’s Phase 2 GALAXY trial. GALAXY is a global Phase 2 clinical trial designed to evaluate the efficacy and safety of xelafaslatide (formerly ONL1204) in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). X

IBSRELA patients reported treatment satisfaction in real-world survey Post-hoc analysis of T3MPO-1 and T3MPO-2 studies demonstrates effectiveness of IBSRELA in reducing abdominal bloating for patients with IBS-C Analysis of electronic health records suggests IBSRELA may reduce burden to healthcare system Oct. 28, 2025 -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet signifi

SPVN20 aims to restore visual acuity and aspects of color vision by creating an alternative light-signaling cascade in malfunctioning cone photoreceptors Delivered through a single intravitreal injection, SPVN20 targets prevalent retinal diseases with no existing standard of care independently of their causes 28 October 2025 – SparingVision (“the Company”), a clinical-stage genomic medicine company transforming the treatment of retinal diseases, today announced that the first patient has been s

Oct. 28, 2025 -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will present a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025, taking place October 24–29 at McCormick Place Convention Center in Chicago, Illinois. The presentation will feature clinical data from the recently announced Phase IIa (ENX-CL-05-001) 3-month topline data readout for Allocetra

Oct. 27, 2025 -- MicrobiotiX Co., Ltd. (CEO Dongeun Yong), a company specializing in the development of novel bacteriophage therapeutics, announced on October 27 that it received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) on October 21 for MP101, its investigational bacteriophage therapy for patients with acute pneumonia. With this approval, MicrobiotiX becomes the first company in Korea to initiate a first-in-human (FIH) clinical trial for a bacte

Oct. 27, 2025 -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) has granted rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG). Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid

Oct. 27, 2025 -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in a Phase I clinical trial of BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”). BMF-650 is an orally administered, next-generation small molecule GLP-1 RA being developed by Biomea for the treatment of o

- Obexelimab met primary endpoint with a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo, p=0.0009 Oct. 27, 2025 -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced positive results from the Phase 2 MoonStone tri

Results from pre-clinical studies demonstrate immunomodulatory activity of QEL-005 across multiple immune cell lineages involved in complex autoimmune inflammation, including B cells, T cells and inflammatory macrophages Broad mechanism of action of QEL-005 provides clear product differentiation compared to CAR-T and other B-cell depletion approaches, offering a potentially safer and better tolerated therapeutic option Data being presented supports CTA filings in Q4 ahead of initiating the CHILL

The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological biomarkers from the previous six patients in Cohorts 1 through 3, the