Newron

Bengaluru: Italy

Newron Pharma updates on US FDA clinical trial hold and phase 3 ENIGMA-TRS development programme

Management call today at 3.30 pm CEST Newron received the anticipated FDA written communication on clinical hold at U.S. study centers and is reviewing feedback and preparing its response ENIGMA-TRS 1 enrollment expected to be completed by mid-Oct...

After one patient death prompted an FDA hold this spring, Newron Pharmaceuticals has now shared that a total of four fatalities have been recorded among participants receiving its schizophrenia candidate. A fifth death was recorded among those taking the

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Newron is moving Phase 3 enrollment to Europe, Asia and Latin America after the FDA kept its US halt; shares are down 67% this year.

Ad hoc announcement pursuant to Art. 53 LR U.S. clinical hold remains in place; study continues in all other countries Company initiates expansion of clinical sites and enrollment in Europe, Asia and Latin America Topline data from ENIGMA-TRS 1 expected i

Ad hoc announcement pursuant to Art. 53 LRMILAN, Italy and MORRISTOWN, N. J., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Newron Pharmaceuticals S.p.A. (