Short answer
MapLight Therapeutics, Inc. (MPLT) filed an 8-K current report with the SEC on June 22, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.2). June 22, 2026 conference call covering topline IRIS Phase 2 results for ML-004 in autism spectrum disorder.
MapLight Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- June 22, 2026 conference call covering topline IRIS Phase 2 results for ML-004 in autism spectrum disorder
- Results represent a key clinical catalyst for MapLight’s ML-004 development program
- Investor presentation furnished as Exhibit 99.1 for detailed efficacy and safety data
Item 8.01 · Other Events
- Press release announced IRIS trial results on June 22, 2026
- Clinical data may materially influence MPLT’s development timeline, regulatory prospects, and valuation
- Full trial findings available in Exhibit 99.2
Item EX-99.1 · Exhibit EX-99.2
- Phase 2 IRIS missed its primary social-communication endpoint, limiting ML-004’s near-term path in that indication
- Prespecified adolescent subgroup with ABC-I ≥16 showed strong irritability benefit: effect size 1.33, nominal p=0.013
- Clinician-rated CGI-I irritability also improved in adolescents: effect size 1.08, nominal p=0.036
- Safety profile potentially differentiated from atypical antipsychotics: no severe or serious events, EPS, or placebo-adjusted weight gain
- Company plans an FDA EOP2 meeting, making regulatory feedback the key catalyst for ML-004’s next development stage
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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