Ad hoc announcement pursuant to Art. 53 LR
Newron reports a pause in enrollment of new study participants in US centers of ENIGMA-TRS 2 study
Pause of enrollment limited to US sites in ENIGMA-TRS 2; Global ENIGMA-TRS 1 study continues with over 400 patients enrolled
Milan, Italy, and Morristown, NJ, USA – April 29, 2026, 5:50 pm CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today announced that the U.S. Food and Drug Administration (FDA) has placed a hold on the enrollment of new patients in the US sites of its Phase III ENIGMA-TRS 2 study of evenamide, targeting the modulation of excessive release of glutamate in patients suffering from treatment-resistant schizophrenia (TRS).
The FDA action follows Newron’s notification to the agency of the sudden death (SUD) of a study participant at a clinical site outside the United States. The investigator assessed the event as unrelated to study treatment. Newron has informed the independent international safety monitoring board for the overall ENIGMA-TRS program, which has reviewed the event and recommended that the studies continue as designed. ENIGMA-TRS 1, performed in 21 countries, continues with over 400 patients having been enrolled. ENIGMA-TRS 2 has received regulatory approval in Argentina and India and is in final stages of receiving approval in Colombia and Malaysia.
Newron is working closely with the FDA and intends to provide the requested information to support resolution of the hold and the resumption of enrollment at U.S. sites for the ENIGMA-TRS 2 study.
“Patient safety remains our highest priority, all patients who enroll in the evenamide program are thoroughly evaluated. The ENIGMA-TRS program with evenamide is monitored by an independent international safety monitoring board. The board has been informed of the event and has concluded that the studies should continue as designed. In the evenamide development program, to date, there is no increase in the risk of mortality between evenamide and placebo-treated patients based on the duration of treatment. Sudden death unfortunately is not uncommon in patients with schizophrenia,” said Ravi Anand, Newron’s Chief Medical Officer.
Studies show that schizophrenia significantly increases mortality and reduces life expectancy by 10-25 years compared with the general population and sudden unexpected deaths (SUD) are noted in at least 20% of these cases of mortality[1].
