Biotherapeutics company PureTech Health plc (Nasdaq: PRTC) (LSE: PRTC) reported on Wednesday that its founded entity biopharmaceutical company Karuna Therapeutics Inc (Nasdaq: KRTX) has won acceptance of its New Drug Application (NDA) for KarXT by the US Food and Drug Administration (FDA).
KarXT, co-invented by PureTech, is aimed at treating schizophrenia in adults.
The Prescription Drug User Fee Act (PDUFA) action date is set for 26 September 2024.
If approved, KarXT, based on the EMERGENT clinical trial data, could mark a groundbreaking pharmacological approach to schizophrenia treatment, representing PureTech's third successful venture from inception to FDA approval.
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