Newron Takes Evenamide Story on the Road as FDA Clinical Hold Adds an Asterisk

Newron's Evenamide faces FDA hold on U.S. enrollment after participant death, but global trials continue. CEO to address investors at key conferences with €38M capital boost.

Newron’s top brass are boarding planes to New York this week, armed with slides on their lead schizophrenia candidate Evenamide and a fresh €38 million capital injection. CEO Stefan Weber and CFO Roberto Galli will present at the Jefferies Global Healthcare Conference on 4 June, before shifting to the virtual H.C. Wainwright Neuro Perspectives conference mid-month. It is the company’s most concentrated institutional outreach of the year, but the trip comes with a regulatory shadow: the U.S. Food and Drug Administration has placed a clinical hold on new patient enrollment at American sites of the ENIGMA-TRS-2 study.

The hold was triggered by the sudden death of a participant at a site outside the United States. The investigator deemed the event unrelated to treatment, and an independent safety monitoring board recommended the studies continue. Newron says it is working closely with the FDA to provide the requested information and resume recruitment. The restriction applies only to U.S. sites of ENIGMA-TRS-2; the global ENIGMA-TRS-1 study, which has already enrolled more than 400 patients, continues unaffected. Primary results from that pivotal trial are expected in the fourth quarter of 2026, measuring the change in PANSS score from baseline after twelve weeks.

Evenamide, a first-in-class glutamate modulator, is being developed as an add-on therapy for treatment-resistant schizophrenia. Earlier clinical data have shown increasing efficacy over time with a favorable safety profile, according to the company. The program has taken on an international dimension: EA Pharma, part of the Eisai group, launched its own Phase III study in Japan in January, and a development and marketing agreement is in place with Myung In Pharm for South Korea. In the same month, the European Patent Office granted an additional substance patent covering crystalline forms and manufacturing processes for Evenamide, extending protection until 2044.

On the financial front, Newron completed a capital increase of up to €38 million in February with backing from existing and new investors in Europe and Asia. The European Investment Bank also extended the maturity of all outstanding tranches of its 2018 loan to June 2028. Meanwhile, the approved Parkinson’s drug Xadago (safinamide) continues to generate revenue through partners: Zambon in the EU, Supernus in the U.S., and Meiji Seika in Japan and other Asian markets.

Despite these positives, the stock has taken a beating. The shares, last seen at €14.05, have shed roughly 57% from their January high of €32.95, and briefly touched €13.75 in recent trading. Four new U.S. and European analysts have initiated coverage, but the conference circuit now carries added weight: management must address the FDA hold head-on while convincing investors that the ENIGMA program remains on track for a data catalyst that could reshape the stock’s trajectory later this year. The presentations in New York and online offer a chance to reset the narrative, but the ultimate verdict will come from the PANSS scores due in Q4.