Newron's Evenamide Stalls in the US as FDA Keeps Recruitment Freeze in Place

Newron shares dropped 16% to EUR 8.50 after the FDA declined to lift its US enrollment hold on the Phase III ENIGMA-TRS 2 trial of Evenamide.

Newron SpA has hit a regulatory wall in the world's most lucrative pharmaceutical market. The Italian drugmaker confirmed that the US Food and Drug Administration will not lift its hold on new patient enrollment at American sites for the Phase III ENIGMA-TRS 2 trial of Evenamide, its lead candidate for treatment-resistant schizophrenia.

Investors wasted little time reacting. The stock shed 16% during the session to trade at EUR 8.50, extending a slide that has left the shares roughly 75% below their 52-week high. Earlier in the day the equity had touched EUR 9.20, a fresh 52-week low, underscoring how quickly sentiment has deteriorated.

A Timeline That Refuses to Close

The FDA first imposed the recruitment freeze on April 29, following the sudden death of a trial participant at a site outside the United States. The treating investigator determined the death was not treatment-related, and an independent international safety panel recommended that the program continue. No US participant had received Evenamide at that point — American enrollees were still in screening.

Hopes for a swift resolution ran high after a constructive Type A meeting with the regulator on September 22. Management had expected US recruitment to resume shortly thereafter. Instead, Newron is now awaiting a written explanation from the agency, along with any conditions it may attach to amendments of the study protocol.

Enrollment Presses On Beyond American Borders

While US sites remain frozen, the international arm of ENIGMA-TRS 2 continues to enroll. Newron intends to open additional centers across Europe, Asia and Latin America to keep the program on track. Roughly 80 participants are currently in the screening phase, against a minimum target of 400 patients.

The twelve-week study tests Evenamide at 15 milligrams twice daily as an add-on therapy versus placebo. Supportive evidence comes from an earlier trial of 291 patients, in which the PANSS score fell 10.2 points by day 29 among those taking Evenamide, compared with a 7.6-point decline in the placebo arm.

The Sister Study Carries the Baton

Untouched by the FDA's action is ENIGMA-TRS 1, the longer companion trial running at sites across 20 countries. That program evaluates doses of 15 milligrams and 30 milligrams over 52 weeks and aims to enroll at least 600 patients, a milestone the company expects to reach around mid-October 2026. Top-line results from the primary twelve-week efficacy analysis, measured by PANSS, are penciled in for the first quarter of 2027 — a readout the market regards as the defining moment for the entire schizophrenia franchise.

Cash Position Holds, but Costs Bite

Financing for these ambitions is largely in place. Back in February, Newron secured up to EUR 38 million to advance both registration studies, and roughly three weeks ago an investor group injected a further EUR 5.5 million to support clinical development. Whether that cushion absorbs the full cost of the delay depends heavily on the conditions the FDA spells out in its pending rationale, particularly since replacing missing US patients means building out alternative sites.

The interim numbers illustrate the strain. Research spending climbed to EUR 14.6 million in the first half of 2026, while revenue slipped to EUR 3.2 million year over year. The company posted a net loss of EUR 16.4 million for the six-month period, a sharp swing from the EUR 73,000 deficit recorded a year earlier.

Analysts at Octavian trimmed their price target on Friday to CHF 15 from CHF 17, keeping a "Hold" rating on the shares.