In a regulatory filing, the company stated: “On December 23, 2025, the Company issued a press release providing a regulatory update regarding the development of brilaroxazine for the treatment of schizophrenia, announcing that written feedback from the Company’s pre-new drug application meeting with the U.S. Food and Drug Administration includes a recommendation to conduct a second Phase 3 study to generate additional efficacy and safety data prior to the submission of a NDA of brilaroxazine for the treatment of schizophrenia.”
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