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News
The FDA has flagged four patient deaths in studies of evenamide, Newron Pharmaceuticals' experimental drug for treatment-resistant schizophrenia. The agency raised concerns about a potential fatal heart rhythm risk and has kept a clinical hold on new U.S. enrollment. Newron says investigators deemed three deaths unrelated to the drug and is preparing a response to the FDA.
The U.S. FDA has identified four deaths among patients treated with evenamide, an experimental drug from Italy's Newron Pharmaceuticals targeting treatment-resistant schizophrenia. The agency flagged the deaths as a potential safety signal, noting it could not definitively rule out a fatal arrhythmic mechanism — meaning an irregular heart rhythm could have played a role. Newron's shares dropped 5.7% following the news.
The clinical hold, originally placed earlier this year after a patient's sudden death (deemed unrelated to the drug), remains in effect for new U.S. enrollments. Newron maintains it has found no pattern of heart abnormalities in its safety data, and trial investigators considered three of the four deaths unrelated to evenamide. One death was flagged as possibly related after two autopsies failed to determine a cause. Enrollment outside the U.S. is continuing, and Newron plans to submit a formal response to the FDA.
By the Numbers:
Why it matters: Treatment-resistant schizophrenia is a serious condition with limited therapeutic options, making new treatments urgently needed. The FDA's safety concerns could significantly delay or derail evenamide's path to approval, leaving patients and clinicians watching closely for Newron's next steps.
