Constructive FDA meeting

Newron has announced a constructive Type A meeting with the FDA regarding the enrolment hold affecting US sites in the Phase III ENIGMA-TRS 2 study. The discussion focused on information previously submitted by the company and the changes required by the FDA before it will consider allowing enrolment to resume. Importantly, management indicated that both parties discussed potential actions towards resolving the outstanding issues, with Newron now planning to propose protocol changes agreed with the agency. While the timing of US enrolment resumption remains uncertain, we view this update as encouraging, as it shows continued regulatory engagement, and provides a clearer pathway towards resolving the hold. Meanwhile, the broader ENIGMA-TR...