FDA Accepts Fortress Biotech and Cyprium Therapeutics CUTX-101 NDA Resubmission
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Fortress Biotech and Cyprium Therapeutics announced the FDA's acceptance of their NDA resubmission for CUTX-101, a treatment for Menkes disease. The resubmission is classified as Class 1, with a PDUFA target date of January 14, 2026. Sentynl Therapeutics resubmitted the NDA after addressing manufacturing site compliance issues, with no deficiencies in efficacy or safety data.
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