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Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101
MIAMI, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceut
About this update from Fortress Biotech, Inc.
[{"type":"image","alt":"Fortress Biotech, Inc.","displaySize":"","headline":null,"caption":"Fortress Biotech, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":228,"url":"https://media.zenfs.com/en/globenewswire.com/67d8842b1a3f40249dd9679548ed4862"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/3_0qSM501xaK8lgQjQGDIA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTMxOTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/67d8842b1a3f40249dd9679548ed4862","width":300,"height":228}},"lazy":false},{"type":"text","content":"MIAMI, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients.","length":415,"tagName":"p"},{"type":"text","content":"In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”) assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. Cyprium expects its partner, Sentynl, will work expeditiously to address the FDA’s concerns and pursue resubmission promptly.","length":375,"tagName":"p"},{"type":"text","content":"The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured. The facility recently provided responses to the FDA’s September 2025 re-inspection of the facility, and Sentynl expects to request a meeting with the FDA to discuss the CRL and resubmission of the CUTX-101 NDA. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101’s efficacy and safety data.","length":440,"tagName":"p"},{"type":"text","content":"Pursuant to the transaction with Sentynl, Sentynl will transfer to Cyprium, if issued upon approval, a Rare Pediatric Disease Priority Review Voucher (“PRV”), and Cyprium will also be eligible to receive royalties on net sales of CUTX-101 and up to $129 million in aggregate development and sales milestones from Sentynl.","length":321,"tagName":"p"},{"type":"text","content":"The CUTX-101 NDA was initially granted Priority Review by t...