Fortress Biotech Inc (NASDAQ:FBIO) stock plunged 33.7% Wednesday after the company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for its Menkes disease treatment.
The FDA rejected the New Drug Application for CUTX-101 (copper histidinate), citing current Good Manufacturing Practice (cGMP) deficiencies at the manufacturing facility. The regulatory setback affects the drug intended to treat Menkes disease, a rare genetic disorder, in pediatric patients.
Fortress Biotech noted that the Complete Response Letter did not identify any concerns regarding the drug’s efficacy or safety data. The manufacturing facility has already provided responses to the FDA following a September 2025 re-inspection, and Sentynl Therapeutics, which assumed responsibility for CUTX-101’s development in December 2023, plans to request a meeting with the FDA to discuss resubmission.
The CUTX-101 application had previously been granted Priority Review status by the FDA. Clinical trials had shown significant improvement in overall survival for Menkes disease patients who received early treatment with the drug.
Under the agreement with Sentynl, Cyprium Therapeutics, a majority-owned subsidiary of Fortress, remains eligible to receive a Rare Pediatric Disease Priority Review Voucher if the drug is approved. Additionally, Cyprium could receive royalties on net sales and up to $129 million in development and sales milestones.
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