regulatory
confidence high
sentiment positive
materiality 0.65
Keros receives FDA Orphan Drug designation for KER-065 in Duchenne muscular dystrophy
Keros Therapeutics, Inc.
- FDA granted Orphan Drug designation for KER-065, a TGF-ß family protein-targeting therapy for DMD.
- Designation provides potential 7-year market exclusivity, tax credits, and fee waivers if approved.
- KER-065 is advancing toward a Phase 2 clinical trial in patients with DMD, as stated by CEO.
- DMD affects fewer than 200,000 people in the U.S., qualifying for Orphan Drug status.
- Keros (KROS) is a clinical-stage biopharma focused on TGF-ß signaling disorders.