secwatch.observer — SEC 8-K summary
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Issuer:     MapLight Therapeutics, Inc. (MPLT)
CIK:        0001770069
Form:       8-K
Filed at:   2026-06-22T11:08:42+00:00
Accession:  0001193125-26-276691
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MapLight's ML-004 Phase 2 misses primary endpoint in autism; shows signal in adolescent irritability
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1770069/000119312526276691/0001193125-26-276691-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1770069/000119312526276691/d31456d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-276691

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer