Four Deaths Prompt FDA Safety Concerns About Novel Schizophrenia Drug

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US FDA flags four deaths in Newron's schizophrenia drug ...

Newron Pharmaceuticals S.p.A. (NWPHF) Discusses FDA Clinical Hold and Safety Concerns in ENIGMA-TRS Program for Treatment-Resistant Schizophrenia Transcript

Newron Pharmaceuticals S.p.A. (NWPHF) Discusses FDA Clinical Hold and Safety Concerns in ENIGMA-TRS Program for Treatment-Resistant Schizophrenia October 8,...

Four Deaths Prompt FDA Safety Concerns About Novel Schizophrenia Drug

(MedPage Today) -- The FDA flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said Thursday...

Newron plans heart tests to lift schizophrenia trial hold - European Biotechnology Magazine

Italy's Newron Pharmaceuticals has disclosed that the FDA kept U.S. enrollment in a Phase 3 trial of its schizophrenia drug evenamide on hold, citing five deaths across all the drug's clinical studies. The company will ask the agency to lift the hold by screening patients for hidden heart-rhythm disorders, including with genetic tests.

Newron Provides Update on FDA Clinical Hold and Phase 3 ENIGMA-TRS Development Program

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