FDA keeps U.S. clinical hold on Newron evenamide Phase 3 ENIGMA-TRS 2 enrollment

(AWP Alliance News) - Newron Pharmaceuticals said the FDA will keep a clinical hold on new patient enrollment at U.S. sites in its Phase 3 ENIGMA-TRS 2 trial of evenamide for treatment-resistant schizophrenia. The study will continue outside the U.S., while the company awaits written FDA feedback on additional protocol changes needed to lift the hold.

Newron is expanding clinical sites and enrollment in Europe, Asia, and Latin America. About 80 patients have entered screening, with the trial targeting at least 400 enrollments after a 42-day screening period.

http://www.globenewswire.com/newsroom/news.html?d=9834122

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 GlobeNewswire on September 25, 2026, and is solely responsible for the information contained therein.