Newron Pharmaceuticals - Positive top-line data to support clinical progress

Newron Pharmaceuticals has announced positive top-line results from its Phase II trial (study 014) assessing evenamide, a glutamate modulator, as an add-on therapy to antipsychotics in moderate-to-severe treatment resistant schizophrenia (TRS). While detailed data (for the full 161 patient cohort over the six-week treatment period) have not been disclosed, management asserts that the results were similar to the six-week interim safety and efficacy data from the first 100 patients reported in June 2022. Newron intends to begin a potentially pivotal multinational Phase III study (study 003) in TRS patients (expected to start in H223) and, in our view, its initiation represents a future catalyst for investor attention. We anticipate that the 52-week results from the full evenamide extension study (study 015) in Q124, if positive, will further enhance the existing evenamide data package and support future regulatory discussions.