FDA Hold Review Continues As Newron Advances Phase 3 Evenamide Program
(RTTNews) - Newron Pharmaceuticals (NP5.DE) said the FDA has provided written feedback regarding the clinical hold affecting U.S. sites in its Phase 3 ENIGMA-TRS 2 study of evenamide, and the company is preparing a response.
Enrollment in Phase 3 ENIGMA-TRS 1 is expected to be completed by mid-October 2026, with topline 12-week results anticipated in the first quarter of 2027.
Enrollment in ENIGMA-TRS2 continues outside the United States, with additional trial sites being added as planned.
The FDA cited a potential safety signal related to cardiovascular risks associated with the sodium-channel blocker class of drugs.
NP5.DE is currently trading at EUR 7.70, down 0.26%.
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