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Reviva Announces Regulatory Update Regarding the Development of Brilaroxazine for the Treatment of Schizophrenia
Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year Initiation of RECOVER-2 registrational trial planned in H1 2026, subject to sufficient finan
About this update from Reviva Pharmaceuticals Holdings, Inc.
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