FDA keeps U.S. clinical hold on Newron evenamide Phase 3 ENIGMA-TRS 2 enrollment

• FDA kept a U.S. clinical hold on enrolling new patients in Newron’s Phase 3 ENIGMA-TRS 2 trial of evenamide.
• Enrollment continues outside the U.S., shifting near-term trial execution toward Europe, Asia, Latin America.
• New clinical sites and enrollment expansion launched in those regions; about 80 patients have entered screening.
• Company expects written FDA feedback on steps needed to lift the hold, including possible protocol changes.

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 GlobeNewswire (Ref. ID: 202609251145PRIMZONEFULLFEED9834122) on September 25, 2026, and is solely responsible for the information contained therein.