FDA accepts Sentynl’s CUTX-101 NDA resubmission
The US Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients.
The resubmission, filed by Sentynl Therapeutics – a Zydus Lifesciences (NYSE: ZYDUSSLIFE) company - has been accepted as a Class I response and as a result, the company has received January 14, 2026 as the PDUFA date. Sentynl acquired rights to CUTX-101 from Cyprium Therapeutics, a subsidiary of Fortress Biotech (Nasdaq: FBIO), in 2023.
"We appreciate the Agency's partnership and commitment to expeditiously reviewing our NDA resubmission," said Matt Heck, chief executive of Sentynl, adding: "The acceptance of the application brings us one step closer to a milestone for patients and families who are living with Menkes disease."
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