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Sentynl Therapeutics Announces FDA Acceptance of CUTX-101 NDA Resubmission
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Sentynl Therapeutics Announces FDA Acceptance of CUTX-101 NDA Resubmission
The investigational copper histidinate candidate receives new PDUFA Target Action Date of January 14, 2026 SOLANA BEACH, Calif., Dec. 15, 2025 /PRNewswire/ — 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 …
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