Keros Therapeutics Inc (Nasdaq:KROS), a US-based clinical-stage biopharmaceutical company focused on developing and commercialising novel therapeutics to treat disorders linked to dysfunctional signalling of the transforming growth factor-beta (TGF-beta) family of proteins, announced on Wednesday that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for KER-065 for the treatment of Duchenne muscular dystrophy ('DMD').

"Receiving Orphan Drug designation for KER-065 highlights the significant unmet medical need for patients with DMD," said Jasbir S. Seehra, president and chief executive officer. "This designation serves as a significant milestone for Keros as we advance KER-065 into a Phase 2 clinical trial in patients with DMD."

The FDA grants Orphan Drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. This designation provides certain potential benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved.