• Newron received FDA written feedback keeping a clinical hold in place at U.S. centers in the Phase 3 ENIGMA-TRS 2 study.
• The agency flagged a potential cardiac safety signal tied to deaths in the evenamide program, prompting added screening plans.
• Management is reviewing the feedback, preparing a response, and has not reported new trial results in this update.
• ENIGMA-TRS 1 enrollment is expected to finish by mid-October, with topline 12-week data due in Q1 2027.
• ENIGMA-TRS 2 enrollment continues outside the U.S., with additional sites being added while the U.S. pause remains.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Newron Pharmaceuticals S.p.A. published the original content used to generate this news brief via EQS News (Ref. ID: corporate_2412180_en) on October 08, 2026, and is solely responsible for the information contained therein.