Oct. 01, 2025 -- COUR Pharma, a clinical-stage biotechnology company developing first-in-class, antigen-specific immune tolerance therapies for autoimmune diseases, announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CNP-106, an investigational therapy for the treatment of generalized myasthenia gravis (gMG). CNP-106 is a biodegradable nanoparticle that encapsulates seven acetylcholine receptor (AChR) antigens. It is being evaluated for its p

Groundbreaking study demonstrates that targeted oligodendrocyte gene therapy leads to decreased N-acetylaspartate (NAA) levels and increased brain myelin volume, resulting in promising functional improvements in children with Canavan Disease Oct. 01, 2025 -- Myrtelle Inc. (“Myrtelle” or the “Company), a pioneering clinical-stage gene therapy company developing transformative treatments for neurodegenerative diseases, today announced the publication of interim results from its Phase 1/2 clinica

Sept. 30, 2025 -- Umoja Biopharma, the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of prior therapy. UB-VV111 is an investigation

Sept. 30, 2025 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL. Dr. Shmuel Sharoni will deliver a presentation titled "Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On

Publication title: “Oral Blarcamesine Phase IIb/III Trial Confirms Identified Precision Medicine Patient Population – Significant Broad Clinical and Quality of Life Improvements for Early Alzheimer’s Disease Patients” Significant improvement in self-assessed Quality of Life (QoL-AD) scores indicating a reversal of negative trajectory for Alzheimer's disease clinical trial participants was observed Using a novel Precision Medicine approach, up to ~70% of Alzheimer's disease participants benefited

Sept. 29, 2025 -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. The manuscript, titled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” has been submitted for peer review to npj Dementia, a Nature Portfolio journal. The detailed manuscript provides a comprehens

Sept. 29, 2025 -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced the start of a preclinical study of its lead investigational drug PV-10 in an orthotopic bladder cancer model. Results are expected in the first quarter of 2026. PV-10 is formulated from the Company’s pharmaceutical-grade rose bengal sodium active pharmaceutical ingredient. Conducted by Translational Drug Development, LLC (TD2), the study will evaluate PV-10’s performance across di

Sept. 29, 2025 -- MindRank AI Ltd., a clinical-stage artificial intelligence (AI)-empowered drug discovery company, today announced the positive topline results of its oral small-molecule GLP-1 receptor agonist MDR-001 in adults with overweight or obesity. Using an optimized once-daily (QD) regimen, MDR-001 achieved a body weight reduction of 8.9% over 12 weeks, compared to 0.6% in the placebo group (Pwith a favorable safety and tolerability profile. This clinical study was "A randomized, doubl

Sept. 29, 2025 -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that clinical data from the Phase 3 study in China evaluating telitacicept in adults with primary Sjögren’s disease, a study sponsored by Vor’s collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), will be presented as a late-breaking poster presentation at ACR Convergence 2025, being held October 24-29, 2025, at McCormick Place in Chicago, Illino

-- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance -- -- KPI-012 was well-tolerated with no treatment-related serious adverse events observed -- -- KALA to cease clinical development of KPI-012, preserve cash and explore strategic options -- Sept. 29, 2025 -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovati