Capricor Gets FDA Nod for DMD Cardiomyopathy Drug Trial
Capricor Therapeutics announced the completion of a mid-cycle review meeting with the FDA for its Biologics License Application (BLA)...
WTX-921 Shows Promising Preclinical Data for IBD Treatment
Werewolf Therapeutics presented data at IMMUNOLOGY2025 demonstrating the efficacy of WTX-921, a conditionally activated IL-10 drug, in a mouse...
OPGX-LCA5 Gene Therapy Restores Meaningful Vision in Phase 1/2 Trial
Opus Genetics announced one-year results from a Phase 1/2 study of its lead gene therapy candidate, OPGx-LCA5, for patients...
UBX1325 DME Phase 2b Study: 36-Week Results & Corporate Updates
UNITY Biotechnology announced 36-week results from its Phase 2b ASPIRE trial of UBX1325 for diabetic macular edema (DME). The...
Chemomab Announces Positive Phase 2 Nebakitug Clinical Data in PSC at DDW 2025
Chemomab Therapeutics announced positive Phase 2 SPRING trial data for nebokitug (CM-101) in primary sclerosing cholangitis (PSC) at Digestive...
FDA Grants Fast Track to Alterity’s ATH434 for Multiple System Atrophy
Alterity Therapeutics has received Fast Track designation from the U.S. FDA for ATH434, a treatment for Multiple System Atrophy...
Stem Cell Therapy for Alzheimer’s: Phase 1 Trial Data at ISCT 2025
Regeneration Biomedical, Inc. (RBI) announced positive interim results from its Phase 1 clinical trial of a novel Alzheimer’s diseaseAlzheimer’s...
Dianthus Completes Phase 2 Trial Enrollment: Top-Line Results Expected
Dianthus Therapeutics has completed enrollment in its Phase 2 MaGic trial of DNTH103 for generalized Myasthenia Gravis (gMG), exceeding...
Guided, Then Penalized: A Deep Dive into the FDA’s MDMA Ruling and What it Means for Psychedelic Clinical Trials
In August 2024, the FDA rejected the New Drug Application for MDMA-assisted therapy for PTSD, sponsored by Lykos Therapeutics,...
Inquis Medical’s AVENTUS Thrombectomy System Safe, Effective for PE
Inquis Medical announced positive results from its AVENTUS IDE trial, evaluating the safety and efficacy of its AVENTUS Thrombectomy...