FDA Accepts Fortress Biotech and Cyprium Therapeutics CUTX-101 NDA Resubmission

Reuters12-15

FDA Accepts Fortress Biotech and Cyprium <a href="https://laohu8.com/S/LENZ">Therapeutics</a> CUTX-101 NDA Resubmission

Fortress Biotech Inc. and its majority-owned subsidiary, Cyprium Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for CUTX-101, a treatment for Menkes disease in pediatric patients. The NDA resubmission has been classified as a Class 1 resubmission, setting a new Prescription Drug User Fee Act (PDUFA) target action date of January 14, 2026. Sentynl Therapeutics, which assumed full responsibility for the development and commercialization of CUTX-101 in December 2023, resubmitted the NDA following a complete response letter from the FDA regarding manufacturing site compliance. No deficiencies were cited in the therapy's efficacy or safety data.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fortress Biotech Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9601996-en) on December 15, 2025, and is solely responsible for the information contained therein.

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