Sentynl Therapeutics Announces FDA Acceptance of CUTX-101 NDA Resubmission

Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), today announced that the U.S. 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 has been accepted as a Class I response and as a result, the Company has received January 14, 2026 as the new PDUFA date.

"We appreciate the Agency's partnership and commitment to expeditiously reviewing our NDA resubmission," said Matt Heck, CEO, Sentynl. "The acceptance of the application brings us one step closer to a milestone for patients and families who are living with Menkes disease."

Sentynl resubmitted its revised NDA on November 14, 2025 after receiving a complete response letter (CRL) from the FDA on September 30, 2025, which cited observations regarding the manufacturing site's cGMP compliance. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101's efficacy and safety data, which demonstrate improvement in overall survival for Menkes disease subjects who received early treatment with the therapy.

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease, a rare X-linked recessive pediatric genetic disease that impacts an estimated 1 in 34,810 to as high as 1 in 8,664 live male births. (Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD)).

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Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals SentynlTherapeutics USFDA Resubmission NDA