{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-077060","form_type":"8-K","ticker":"CGTX","cik":"0001455365","company_name":"COGNITION THERAPEUTICS INC","filed_at":"2026-06-24T11:39:06+00:00","discovered_at":"2026-06-24T11:40:00.296100+00:00","generated_at":"2026-06-24T11:40:10.555234+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Cognition Therapeutics receives FDA alignment on pivotal trial design for zervimesine in DLB psychosis","bullets":["FDA agreed that DLB psychosis is an approvable outcome; key aspects of Phase 3 trial design aligned.","Phase 3 study expected to start mid-2027; enrollment of DLB patients with psychosis, randomized to 100 mg zervimesine or placebo for 9 months.","Company to use NPI as novel primary endpoint; FDA will collaborate on analytical and statistical details.","Phase 2 SHIMMER trial showed zervimesine slowed progression of hallucinations and delusions by 89% vs placebo.","No approved treatments for DLB psychosis; current off-label antipsychotics are considered potentially dangerous."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-077060","json":"https://secwatch.observer/filing/0001104659-26-077060.json","markdown":"https://secwatch.observer/filing/0001104659-26-077060.md","text":"https://secwatch.observer/filing/0001104659-26-077060.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1455365/000110465926077060/0001104659-26-077060-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1455365/000110465926077060/tm2618699d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T11:40:10.555234+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"}