The FDA decision on Sentynl Therapeutics Inc.’s drug candidate CUTX-101 is under priority review by the FDA, with a decision expected on September 30, 2025. CUTX-101, a subcutaneous injectable formulation of copper histidinate, is proposed for the treatment of Menkes disease, a rare X-linked recessive pediatric disease. Menkes disease is caused by mutations of ATP7A, a gene that regulates the metabolism of copper in the body. The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, low muscle tone (hypotonia), poor growth (failure to thrive), and developmental delays. Mortality is high in untreated Menkes disease, with many patients dying between 2-3 years of age. CUTX-101 was developed by Cyprium Therapeutics, a subsidiary of Fortress Biotech. In December 2023, the responsibility for both development and commercialization of CUTX-101 was fully transferred to Sentynl Therapeutics. FBIO closed Wednesday’s (Aug.27, 2025) trading at $2.34, down 0.43%.