FDA拒绝罕见病药物，Fortress Biotech股价暴跌

2025-10-01 20:59

Fortress Biotech (NASDAQ:FBIO) fell ~31% in the premarket on Wednesday after the U.S. Food and Drug Administration (FDA) declined to approve CUTX-101, a treatment developed by the company and its India-based partner Zydus Lifesciences for a rare condition called Menkes disease.
In a statement on Wednesday, the Florida-based biotech and its subsidiary Cyprium Therapeutics said that the FDA issued a complete response letter in relation to a New Drug Application for CUTX-101 targeted at pediatric Menkes disease.
The FDA has cited no approvability concerns in the CRL except manufacturing issues found at a facility where the drug is produced, the company said, adding that the site has already responded to regulatory concerns raised during a September re-inspection of the facility.
Fortress Biotech (NASDAQ:FBIO) noted that Zydus, which obtained commercial and R&D rights for CUTX-101 in 2023 from Cyprium, will seek a meeting with the FDA to discuss the CRL and a potential resubmission of the NDA.

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