other material
confidence high
sentiment negative
materiality 0.75
MapLight's ML-004 Phase 2 misses primary endpoint in autism; shows signal in adolescent irritability
MapLight Therapeutics, Inc.
- Primary endpoint (ABI-Social Communication) not met in Phase 2 IRIS trial of ML-004 in ASD.
- Adolescents with baseline ABC-I≥16 showed improvement (ES=1.33, p=0.013) on ABC-I and CGI-I irritability (ES=1.08, p=0.036).
- ML-004 well-tolerated; no severe/serious AEs in active arm, no extrapyramidal events, weight gain lower than placebo.
- Company to engage FDA for End-of-Phase 2 meeting; Phase 2 ZEPHYR (schizophrenia) topline due mid-Aug 2026.