US FDA Maintains Clinical Hold on Patient Enrollment for Newron's Phase 3 Trial of Schizophrenia Drug

11:35 PM EDT, 09/27/2026 (MT Newswires) -- Newron Pharmaceuticals (NWRN.SW) received information that the US Food and Drug Administration extended the clinical hold on patient enrollment in the country for the phase 3 Enigma-TRS 2 study of the schizophrenia drug evenamide. The biopharmaceutical company said Sept. 25 it expects to receive written communication from the regulator with more information about the decision and potential resolutions of the order. Amid the suspension in the US, Newron expanded the study in Europe, Asia and Latin America, targeting the enrollment of at least 400 patients after a 42-day screening period. Enigma-TRS 2 is currently underway in four countries. Meanwhile, Newron expects topline results from the Enigma-TRS 1 trial in the first quarter of 2027.