Newron Halts US Recruitment for Evenamide Phase-3 Study Amid FDA Pause

Newron, a Swiss-listed biopharma company developing Evenamide—a potential treatment for treatment-resistant schizophrenia—has suspended new patient recruitment in the United States for its Phase-3 Enigma-Trs 2 study. The pause follows confirmation from the U.S. Food and Drug Administration (FDA) that the temporary enrollment halt remains in effect, following a participant’s death outside the U.S. that the company disclosed in April 2024. The FDA has not yet provided further details in writing, including whether additional protocol changes may be required to lift the hold. Meanwhile, recruitment for the study continues in other regions, with Newron expanding enrollment to additional sites in Europe, Asia, and Latin America. Around 80 patients have already entered the trial, with a target of at least 400 participants. The 12-week study compares Evenamide against a placebo for patients with treatment-resistant schizophrenia—a form of the condition unresponsive to conventional therapies. A parallel Phase-1 study, Enigma-Trs 1, is ongoing in 20 countries with at least 600 participants over 52 weeks. Newron anticipates initial results from Enigma-Trs 1 in the first quarter of 2027.