Clinical trials:
- In May, the Company announced regulatory approval for its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with treatment-resistant schizophrenia (TRS). The program consists of two pivotal studies:
- ENIGMA-TRS 1, an international, one-year, double-blind, placebo-controlled Phase III study in at least 600 patients. Following a successful screening period, patient enrolment began post-period, in August 2025, with 12-week study results expected in Q4 2026
- ENIGMA-TRS 2, approved by the US Food and Drug Administration, to be performed at centers in the US and selected additional countries. This 12-week, double-blind, placebo-controlled Phase III study in at least 400 patients is expected to start by October 2025
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