Karuna Therapeutics Announces US FDA Accepts New Drug Application for KarXT for the Treatment of Schizophrenia
Portfolio Pulse from Benzinga Newsdesk
Karuna Therapeutics, Inc. (NASDAQ:KRTX) announced that the FDA has accepted its New Drug Application for KarXT for the treatment of schizophrenia in adults. The PDUFA date is set for September 26, 2024, which is the target action date for the FDA to make a decision on the drug's approval.
November 29, 2023 | 11:31 am
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Karuna Therapeutics' KarXT NDA for schizophrenia treatment has been accepted by the FDA, with a decision expected by September 26, 2024.
The acceptance of the NDA by the FDA is a significant milestone for Karuna Therapeutics, indicating progress in the drug's development pathway. This news is likely to be viewed positively by investors as it moves KarXT closer to potential market approval. The setting of a PDUFA date provides a clear timeline for when a decision will be made, which can lead to increased investor anticipation and potentially positive stock price movement in the short term.
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