In a regulatory filing, the company said that on September 13, it completed enrollment in its open label clinical study designed to evaluate the correlation between the patient-and informant-reported mCGI-S measurement and the Positive and Negative Syndrome Scale-Excitatory Component scale, conducted by trained raters. The study was designed to evaluate approximately 30 patients and the company expects to release the results in the fourth quarter of 2025. The results from this study, along with the results of the SERENITY At-Home Pivotal Phase 3 Safety Trial already announced, will be included in the clinical package for the sNDA submission, which is expected in the first quarter of 2026.
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