Keros Announces U.S. FDA Orphan Drug Designation Granted to KER-065 for the Treatment of Duchenne Muscular Dystrophy
LEXINGTON, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced the U.S. Food and Drug Administration (“FDA”) granted Orphan Drug designation for KER-065 for the treatment of Duchenne muscular dystrophy (“DMD”).
Related Questions
How will the orphan drug designation for KER-065 affect Keros Therapeutics' valuation and short‑term stock volatility?
What are the timelines and regulatory milestones (e.g., IND filing, Phase II/III initiation) for KER‑065, and how might they influence future price catalysts?
How does KER‑065's market potential and competitive positioning compare to other DMD therapies in development, and what impact could that have on market share and revenue forecasts?