Shares of Fortress Biotech Inc. (FBIO) are up over 3% at $4.40 in premarket trading on Tuesday, as its subsidiary Cyprium Therapeutics approaches a key FDA decision.
CUTX-101, a subcutaneous injectable formulation of copper histidinate, developed by Cyprium and proposed for the treatment of Menkes disease, is awaiting a decision from the FDA, expected by January 14, 2025. This is the therapy's second go-around with the FDA.
Last October, the U.S. regulatory agency declined to approve CUTX-101, citing observations regarding the manufacturing site's cGMP compliance.
In December 2023, the responsibility for both the development and commercialization of CUTX-101 was fully transferred to Sentynl Therapeutics. Cyprium is eligible to receive up to $129 million in aggregate development and sales milestones from its partner Sentynl Therapeutics, as well as royalties on net sales of CUTX-101.
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 and 3 years of age.
If approved, CUTX-101 will be the first and only FDA-approved treatment available for Menkes disease.
FBIO closed Monday's trading at $4.20, down 2.33%.
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