FDA issues Complete Response Letter for Fortress Biotech's CUTX-101 over manufacturing issues

Fortress Biotech, Inc.

FDA issued CRL for CUTX-101 NDA to treat Menkes disease; cGMP deficiencies at the manufacturing facility.
No efficacy/safety deficiencies cited; CRL solely based on manufacturing observations at the facility.
Partner Sentynl expects to request FDA meeting and pursue resubmission promptly after facility's recent response.
Cyprium eligible for up to $129M in milestones plus a Rare Pediatric Disease PRV upon NDA approval.
NDA initially granted Priority Review; early treatment showed significant survival improvement in trials.

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