FDA halts U.S. recruitment in Newron’s key schizophrenia trial after patient death

Newron Pharmaceuticals SpA ( (CH:NWRN) ) has issued an update.

Newron Pharmaceuticals said the U.S. Food and Drug Administration has ordered a halt to new patient enrolment at U.S. sites in its Phase III ENIGMA-TRS 2 trial of Evenamide for treatment-resistant schizophrenia, after the company reported a sudden unexpected death of a participant at a non-U.S. site that investigators deemed unrelated to the drug. An independent safety committee has advised that the overall ENIGMA-TRS program continue as planned, with the larger ENIGMA-TRS 1 trial ongoing across 21 countries and ENIGMA-TRS 2 progressing in other territories, while Newron works with the FDA to lift the U.S. recruitment hold and stresses that current data do not show increased mortality with Evenamide versus placebo in this high-risk patient population.

The most recent analyst rating on (CH:NWRN) stock is a Buy with a CHF48.00 price target. To see the full list of analyst forecasts on Newron Pharmaceuticals SpA stock, see the CH:NWRN Stock Forecast page.

More about Newron Pharmaceuticals SpA

Newron Pharmaceuticals is a biopharmaceutical company specializing in novel therapies for central and peripheral nervous system disorders. Headquartered near Milan, it has advanced neuroscience drugs from discovery to market, led by Evenamide, a first-in-class glutamate modulator for treatment-resistant schizophrenia, and Xadago for Parkinson’s disease, marketed globally through regional partners.

Average Trading Volume: 91,821

Technical Sentiment Signal: Buy

Current Market Cap: CHF318.7M

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