{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-21-349137","form_type":"8-K","ticker":"ACAD","cik":"0001070494","company_name":"ACADIA PHARMACEUTICALS INC","filed_at":"2021-12-06T23:59:59+00:00","discovered_at":"2026-05-14T18:04:11.364441+00:00","generated_at":"2026-06-28T03:23:34.889448+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Acadia reports positive Phase 3 trofinetide results in Rett syndrome; NDA plan mid-2022","bullets":["Trofinetide met co-primary endpoints: RSBQ change -5.1 vs -1.7 (p=0.0175); CGI-I 3.5 vs 3.8 (p=0.003).","Key secondary endpoint CSBS-DP-IT-Social also met: -0.1 vs -1.1 (p=0.0064); effect size 0.43.","Discontinuation due to AEs 17.2% trofinetide vs 2.1% placebo; diarrhea (80.6%) and vomiting (26.9%) most common.","Pre-NDA meeting with FDA planned Q1 2022; NDA submission expected mid-2022; Fast Track, Orphan, RPD designations granted.","More than 95% of completers rolled into open-label Lilac extension; Acadia licensed trofinetide from Neuren Pharmaceuticals."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-21-349137","json":"https://secwatch.observer/filing/0001193125-21-349137.json","markdown":"https://secwatch.observer/filing/0001193125-21-349137.md","text":"https://secwatch.observer/filing/0001193125-21-349137.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070494/000119312521349137/0001193125-21-349137-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070494/000119312521349137/d257158d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T03:23:34.889448+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}