secwatch.observer — SEC 8-K summary
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Issuer:     CYTOKINETICS INC (CYTK)
CIK:        0001061983
Form:       8-K
Filed at:   2024-05-08T23:59:59+00:00
Accession:  0000950170-24-055054
Event type: other_material
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Cytokinetics opens enrollment in CEDAR-HCM trial of aficamten in pediatric obstructive HCM
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- Initial cohort ~40 adolescents (12-17) with LVEF ≥60%, Valsalva LVOT-G ≥50 mmHg, NYHA ≥II.
- Dosing starts at 5 mg once daily; up-titration at Wk2/4/6 to 10/15/20 mg based on Valsalva LVOT-G ≥30 mmHg and LVEF ≥55%.
- Primary endpoint: change in Valsalva LVOT-G at Week 12; secondary endpoints include resting LVOT-G, NYHA class, PK, NT-proBNP, hs-cTnI.
- Second cohort of ~8-10 patients aged 6-11 will open after data from ≥20 adolescents complete Week 12.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1061983/000095017024055054/0000950170-24-055054-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1061983/000095017024055054/cytk-20240508.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-055054

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