Newron Pharmaceuticals Reviews US FDA Feedback on Clinical Hold for Schizophrenia Drug Trial

01:38 AM EDT, 10/08/2026 (MT Newswires) -- Newron Pharmaceuticals (NWRN.SW) is reviewing the US Food and Drug Administration's feedback on the clinical hold on US trial sites in the phase 3 Enigma-TRS 2 study of its schizophrenia treatment, evenamide. The regulator flagged potential cardiac safety risks after four reported deaths among evenamide-treated patients across clinical studies, compared with one in the placebo group, according to a Thursday release. Newron said three of the four deaths were deemed unrelated to the drug by investigators, while one was considered "possibly related." The biopharmaceutical company is evaluating additional cardiac screening and monitoring measures before submitting its response. The clinical hold remains in effect at US sites, while enrollment continues elsewhere. Meanwhile, patient recruitment in the Enigma-TRS 1 study is expected to conclude by mid-October 2026, with topline 12-week results anticipated in the first quarter of 2027.