US FDA cites 4 deaths in Newron's schizophrenia drug trial hold

Newron Pharmaceuticals SpA

08/10/2026 13:26

Oct 8 (Reuters) - Italy's Newron Pharmaceuticals NWRN.S said on Thursday the FDA had outlined safety concerns behind a clinical hold at US sites in a late-stage trial of its experimental schizophrenia drug, citing four deaths and irregular heart rhythms. 
Shares of the Switzerland-listed company were down 8.5% in afternoon trading following the news.

Here are some details:
The company said the FDA's concerns were related to a known risk of irregular heart rhythms in patients enrolled in the trial
The agency noted four deaths among patients who received evenamide across all studies, compared with one death among those given a placebo, as a potential safety signal
The drug was tested in people with treatment-resistant schizophrenia, a serious mental illness that affects thinking, emotions and perception of reality
The feedback comes after the FDA earlier this year placed a clinical hold on new patient enrollment in the trial of evenamide following a patient's sudden death, although the event was unrelated to the treatment
Newron said trial investigators considered three of the four deaths unrelated to evenamide. One was considered possibly related because two autopsies did not determine a cause of death
The company said it has not identified a pattern of heart abnormalities or irregular rhythms in data from its studies, including more than 10,000 heart recordings from about 700 patients treated with evenamide
It is assessing additional heart screening and monitoring measures as part of its response to the clinical hold
Newron said the clinical hold remains in place and enrollment in the trial is continuing outside the US

 (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shreya Biswas)
 ((Padmanabhan.Ananthan@thomsonreuters.com;))