MapLight Therapeutics, Inc. Common StockPhase 2 trial results mixed; only one dose met primary endpoint, shares fell >60%.

MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial of ML-007C-MA in adults with an acute exacerbation of schizophrenia. The trial met its primary endpoint, with the 210/3 mg twice-daily dose showing a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale total score compared to placebo at week 5. The twice-daily arm also achieved significance on key secondary endpoints including Clinical Global Impression of Severity and PANSS positive Marder factor. The 330/6 mg once-daily dose demonstrated numerical improvement but did not reach statistical significance on the primary endpoint. The company plans to engage with the FDA at an End-of-Phase 2 meeting to discuss a Phase 3 trial design that would support a New Drug Application submission. MapLight shares fell more than 60% following the announcement.
MapLight Therapeutics, Inc. Common StockPhase 2 trial results mixed; only one dose met primary endpoint, shares fell >60%.