Newron says Phase 3 ENIGMA-TRS 1 enrollment to complete mid-October, topline data due Q1 2027

(AWP Alliance News) - Newron Pharmaceuticals reported it has received written FDA feedback that keeps a clinical hold in place at U.S. sites for its Phase 3 ENIGMA-TRS 2 trial of evenamide in treatment-resistant schizophrenia. The agency flagged a potential safety signal tied to the drug class, citing an imbalance in deaths versus placebo and a possible arrhythmic mechanism that cannot be ruled out.

Newron said it has not seen a pattern of cardiac abnormalities in its broader safety database and is preparing a response that could include added cardiac screening and monitoring in ENIGMA-TRS 2. Separately, enrollment in ENIGMA-TRS 1 is expected to finish by mid-October, with topline 12-week results scheduled for Q1 2027.

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Disclaimer: This news brief was created using generative artificial intelligence. Newron Pharmaceuticals S.p.A. published the original content used to generate this news brief via EQS News on October 08, 2026, and is solely responsible for the information contained therein.