MapLight Therapeutics, Inc. 8K

MapLight Therapeutics reported positive Phase 2 ZEPHYR trial results for ML-007C-MA in schizophrenia, meeting the primary endpoint and key secondary endpoints and supporting advancement to registrational development with planned FDA End-of-Phase 2 discussions.

On July 27, 2026, MapLight Therapeutics, Inc. announced positive topline results from its Phase 2 ZEPHYR trial in adults with an acute exacerbation of schizophrenia, reporting that the 210/3 mg twice-daily dose of its investigational oral M1/M4 muscarinic agonist combination ML-007C-MA achieved statistically significant and clinically meaningful improvement in PANSS total score versus placebo at Week 5, along with significant benefits on key secondary endpoints including CGI-S, PANSS Positive Marder Factor, and cognition in participants with baseline cognitive impairment, while demonstrating a generally favorable safety and tolerability profile; based on these data, the company plans to engage the FDA at an End-of-Phase 2 meeting and proceed with additional registrational trials in schizophrenia and continue development in Alzheimer’s disease psychosis.

Filing Facts

CIK

1770069

Ticker

MPLT

Form

8K

Source Type

fda

Accession

0001193125-26-316820

Alert Tier

6