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.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.