Newron Pharmace Company Research (0QOI)

Newron Pharmaceuticals has announced that the FDA has placed a hold on the enrolment of new patients at US sites in the Phase III ENIGMA-TRS 2 trial. This was due to the sudden death of a participant at a non-US clinical site; however, it is important to highlight that the investigator assessed the event as unrelated to the study treatment (evenamide), while the independent international safety monitoring board reviewed the event and recommended that the ENIGMA-TRS programme continue as designed. As such, the pause is limited to US sites in ENIGMA-TRS 2 only. The registrational ENIGMA-TRS 1 trial continues across 21 countries, with more than 400 patients enrolled, while ENIGMA-TRS 2 has approvals in Argentina and India, with Colombia and Malaysia in the final stages. We view the pause as a manageable regulatory process, rather than a change to the underlying evenamide investment case.