secwatch.observer — SEC 8-K summary
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Issuer:     COGNITION THERAPEUTICS INC (CGTX)
CIK:        0001455365
Form:       8-K
Filed at:   2026-06-24T11:39:06+00:00
Accession:  0001104659-26-077060
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cognition Therapeutics receives FDA alignment on pivotal trial design for zervimesine in DLB psychosis
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1455365/000110465926077060/0001104659-26-077060-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1455365/000110465926077060/tm2618699d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-077060

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