This trial covers the efficacy, safety and tolerability of KarXT in adults with schizophrenia. The clinical trial saw it meets its primary endpoint with a 9.6-point reduction on the Positive and Negative Syndrome Scale (PANSS).
In addition to that, Karuna Therapeutics notes that the treatment saw early and maintained reductions in symptoms on the PANSS score. These started as early as week two and were maintained throughout the entire period of the study.
The clinical trial met its secondary endpoint as well. That includes the reduction of positive symptoms and negative symptoms of schizophrenia on the PANSS positive, PANSS negative, and PANSS negative Marder factor subscales.
All of this is progress toward the submission of a New Drug Application (NDA) for KarXT. The next step is getting results from a long-term clinical trial of the drug, which is expected in the first quarter of 2023. If all goes well, the NDA will be submitted to the U.S. Food and Drug Administration (FDA) in mid-2023.
Today’s news brings with it heavy trading of KRTX stock. This has some 1.7 million shares on the move as of this writing. That’s well above its daily average trading volume of 310,000 shares.
KRTX stock is up 63.8% as of Monday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.