Business

Newron Reports a Pause of Enrollment of New Study Participants in US Centers of ENIGMA-TRS 2 Study

MILAN & MORRISTOWN, N.J., April 29, 2026--Newron reports a pause of enrollment of new study participants in US centers of ENIGMA-TRS 2 study

articleNewron Pharmaceuticals S.p.a.April 29, 20265/company/newron-pharmaceuticals-spa/news/newron-reports-a-pause-of-enrollment-of-new-study-participants-in-us-centers-of-enigma-trs-2-study
Newron Reports a Pause of Enrollment of New Study Participants in US Centers of ENIGMA-TRS 2 Study

About this update from Newron Pharmaceuticals S.p.a.

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":281,"url":"https://media.zenfs.com/en/business-wire.com/159fa9f867dd453bfabd8a45d807772f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/2j.z2J_U0QCCreGP1skbXw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTU2Mg--/https://media.zenfs.com/en/business-wire.com/159fa9f867dd453bfabd8a45d807772f","width":480,"height":281},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/E8ruVu0Fie3IqanKhQrc_w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTY0MDtoPTM3NQ--/https://media.zenfs.com/en/business-wire.com/159fa9f867dd453bfabd8a45d807772f","width":480,"height":281}},"lazy":false},{"type":"text","content":"Pause of enrollment limited to US sites in ENIGMA-TRS 2; Global ENIGMA-TRS 1 study continues with over 400 patients enrolled","length":124,"tagName":"p","attribs":{}},{"type":"text","content":"Ad hoc announcement pursuant to Art. 53 LR","length":42,"tagName":"p","attribs":{}},{"type":"text","content":"MILAN & MORRISTOWN, N.J., April 29, 2026--(BUSINESS WIRE)--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).","length":601,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":652,"tagNam...

More updates from Newron Pharmaceuticals S.p.a.

study participantENIGMA-TRSdevelopment programstudy centerspatientsPharmaceuticalsbiopharmaceutical companyschizophreniainternational safetydevelopment