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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Karuna Therapeutics Inc | NASDAQ:KRTX | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 0 | - |
From Jun 2023 to Jun 2024
By Chris Wack
Karuna Therapeutics said the U.S. Food and Drug Administration has accepted its New Drug Application for KarXT xanomeline-trospium for the treatment of schizophrenia in adults.
The application has been granted a Prescription Drug User Fee Act date of Sept. 26, 2024.
The NDA submission is supported by long-term safety data from the clinical program evaluating KarXT as a treatment for schizophrenia. The program includes the three completed positive trials evaluating the efficacy and safety of KarXT compared with placebo, and trials evaluating the long-term safety of KarXT.
In all three placebo-controlled trials, KarXT met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in symptoms of schizophrenia compared with placebo. KarXT was found to be generally well tolerated, with the most common adverse events being cholinergic in nature and mild to moderate in severity.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
November 29, 2023 06:58 ET (11:58 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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