Newron says US patient enrollment remains paused in ENIGMA-TRS 2 Phase 3 evenamide trial

• Newron kept a US enrollment pause in its Phase 3 ENIGMA-TRS 2 trial of evenamide for treatment-resistant schizophrenia.
• No trial results were presented; top-line results from the separate ENIGMA-TRS 1 Phase 3 study are due in Q1 2027.
• Outside the US, ENIGMA-TRS 2 recruitment continues as the company expands sites across Europe, Asia, Latin America.
• The FDA is expected to send a written notice outlining its decision, potential protocol changes required to lift the hold.
• Strategic impact centers on delayed US patient intake, raising execution risk for ENIGMA-TRS 2 timelines.

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: adhoc_2405800_de) on September 25, 2026, and is solely responsible for the information contained therein.