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FDA Clears Celon Pharma’s Schizophrenia Drug for Phase 3 Trial
Globenewswire· 2025-10-08 10:00
FDA clears path for Phase 3 testing following positive Type B meetingRegulatory alignment confirms preclinical data sufficient for pivotal initiationPhase 3 to include two 28-day trials and a 12-month safety extensionCPL’36 demonstrated strong efficacy and safety in prior Phase 2 studyProgram expansion planned into additional CNS indications, including Parkinson’s disease WARSAW, Poland, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Celon Pharma S.A. (WSE: CLN) announced today it has secured a key regulatory milestone ...