FDA accepts CUTX-101 NDA resubmission as Class 1; PDUFA date Jan 14, 2026

Fortress Biotech, Inc.

FDA accepted NDA resubmission for CUTX-101 (copper histidinate) for Menkes disease; new PDUFA target action date January 14, 2026.
Prior complete response letter in Sept 2025 cited only cGMP manufacturing observations; no efficacy/safety deficiencies.
Sentynl (Zydus unit) leads development/commercialization; Cyprium eligible for up to $129M milestones plus PRV if approved.
CUTX-101 previously granted Priority Review; early treatment showed significant improvement in overall survival.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.