Newron Updates on FDA Evenamide Hold, Secures €38M for Phase III Program
Newron Pharmaceuticals has had a constructive FDA meeting about the clinical hold on its evenamide Phase III ENIGMA-TRS 2 trial and also secured up to €38 million in funding to advance the program. The company plans to propose changes to address the FDA’s concerns, while the financing extends its cash runway beyond key 12-week results.
Newron Pharmaceuticals had a constructive face-to-face Type A meeting with the U.S. FDA to discuss the clinical hold on enrollment of new patients at U.S. sites of its Phase III ENIGMA-TRS 2 study of evenamide in treatment-resistant schizophrenia. Separately, the company has secured up to EUR 38 million from existing and new investors in Europe and Asia to fund the global ENIGMA-TRS program and extend its cash runway beyond the 12-week pivotal results.
The FDA hold was originally reported on April 29, 2026, and the recent meeting focused on potential actions to resolve the issues that led to it. Newron, as agreed with the agency, plans to propose changes to address the FDA’s concerns. Evenamide is a first-in-class glutamate modulator designed to reduce excessive glutamate release in patients with treatment-resistant schizophrenia.
The ENIGMA-TRS program consists of two trials. ENIGMA-TRS 1 is an ongoing 52-week, randomized, double-blind, placebo-controlled Phase III study evaluating 15 mg BID and 30 mg BID doses of evenamide versus placebo in at least 600 patients on second-generation antipsychotics. Enrollment began in August 2025 across 15 countries in Europe, Asia, Latin America, and Canada. The primary endpoint is change from baseline in PANSS scores at 12 weeks, with results expected in Q4 2026. ENIGMA-TRS 2 is a 12-week, randomized, double-blind, placebo-controlled study of the 15 mg BID dose in at least 400 patients at U.S. and selected additional sites, initiated in December 2025 following FDA and IRB approvals before the hold was imposed.
The EUR 38 million financing involves an initial tranche of up to EUR 15 million through the issuance of up to 779,624 new shares at EUR 19.24 per share. Additional proceeds of EUR 11 million and EUR 12 million are contingent on the progress of the ENIGMA-TRS studies and positive results, respectively. The new shares are expected to be listed on the SIX Swiss Exchange and other European exchanges.