Sentynl Therapeutics, a US-based biopharma company wholly-owned by Zydus Lifesciences announced the execution of an assignment and assumption agreement with Cyprium Therapeutics, a Fortress Biotech subsidiary company. Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and US FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl.
Sentynl now assumes full responsibility for the development and commercialisation of CUTX-101. In 2021, Sentynl and Cyprium reported positive results from a safety and efficacy analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101. A rolling submission of the CUTX-101 New Drug Application (NDA) to the FDA is ongoing, with expected completion in 2024.