MapLight says Phase 2 IRIS trial of ML-004 in autism misses primary endpoint

MapLight Therapeutics, Inc.

MapLight Therapeutics, Inc.

MPLT

0.00

  • Maplight Therapeutics reported topline Phase 2 IRIS results for ML-004 in autism spectrum disorder; findings were presented with the announcement.
  • The trial missed its primary goal on social communication, raising uncertainty for the program’s initial development thesis.
  • A prespecified adolescent subgroup with higher baseline irritability showed meaningful improvement versus placebo, supporting a potential pivot toward that symptom domain.
  • ML-004 was generally well tolerated, with no severe or serious adverse events reported in the active-treatment arm.
  • Maplight plans an FDA End-of-Phase 2 meeting to determine next steps; Phase 2 ZEPHYR topline data for ML-007C-MA in schizophrenia is due by mid-August 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Maplight Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606220700PRIMZONEFULLFEED9750208) on June 22, 2026, and is solely responsible for the information contained therein.