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Did Keros Therapeutics gain FDA orphan drug status for DMD treatment with KER-065?

Asked by Anonymous Sep 02, 2026 0 views 1 answers
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Answered Sep 02, 2026

Keros Therapeutics successfully secured Orphan Drug designation from the United States Food and Drug Administration for its investigational product candidate KER-065, intended for the treatment of Duchenne muscular dystrophy. This regulatory milestone recognizes the significant unmet medical need associated with the rare and severe genetic disorder. The designation provides the company with valuable incentives to advance the therapeutic candidate into clinical trials, including potential tax credits for clinical testing, waiver or reduction of specific regulatory application fees, and eligibility for a period of seven years of market exclusivity upon final regulatory approval.

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