{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-326778","form_type":"8-K","ticker":"CYTK","cik":"0001061983","company_name":"CYTOKINETICS INC","filed_at":"2025-12-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.694814+00:00","generated_at":"2026-05-16T12:30:59.815730+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Cytokinetics receives FDA approval for MYQORZO (aficamten) to treat symptomatic oHCM","bullets":["FDA approved MYQORZO (aficamten) on Dec 19, 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).","MYQORZO is an allosteric, reversible inhibitor of cardiac myosin motor activity, reducing contractility and LVOT obstruction.","Available in 5 mg, 10 mg, 15 mg, and 20 mg tablets.","Approval based on data showing improved functional capacity and symptoms in oHCM patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-326778","json":"https://secwatch.observer/filing/0001193125-25-326778.json","markdown":"https://secwatch.observer/filing/0001193125-25-326778.md","text":"https://secwatch.observer/filing/0001193125-25-326778.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1061983/000119312525326778/0001193125-25-326778-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1061983/000119312525326778/cytk-20251219.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:30:59.815730+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":[],"comparable_filings":[{"accession":"0001104659-26-068659","ticker":"OTLK","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-06-01T13:15:32+00:00","headline":"Outlook Therapeutics resubmits BLA for ONS-5010 to FDA; Class 1 review, PDUFA in 60 days","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-068659","json":"https://secwatch.observer/filing/0001104659-26-068659.json","markdown":"https://secwatch.observer/filing/0001104659-26-068659.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/0001104659-26-068659-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/tm2616461d1_8k.htm"},"side_by_side_evidence":null},{"accession":"0001140361-26-022979","ticker":"BBIO","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-05-27T20:01:34+00:00","headline":"FDA accepts NDA for BBP-418 with Priority Review; PDUFA Nov 27, 2026","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-022979","json":"https://secwatch.observer/filing/0001140361-26-022979.json","markdown":"https://secwatch.observer/filing/0001140361-26-022979.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/0001140361-26-022979-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/ef20074977_8k.htm"},"side_by_side_evidence":null},{"accession":"0001104659-26-065992","ticker":"OTLK","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-05-26T11:15:41+00:00","headline":"FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-065992","json":"https://secwatch.observer/filing/0001104659-26-065992.json","markdown":"https://secwatch.observer/filing/0001104659-26-065992.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/0001104659-26-065992-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/tm2615583d1_8k.htm"},"side_by_side_evidence":null},{"accession":"0001104659-26-064861","ticker":"RGTI","company_name":"Rigetti Computing, Inc.","filed_at":"2026-05-21T11:30:49+00:00","headline":"Rigetti signs LOI for up to $100M CHIPS Act award for quantum R&D; government to receive equity","event_type":"regulatory","sec_items":["3.02","8.01","7.01","9.01"],"materiality_score":0.8,"calibrated_materiality_score":0.8,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-064861","json":"https://secwatch.observer/filing/0001104659-26-064861.json","markdown":"https://secwatch.observer/filing/0001104659-26-064861.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1838359/000110465926064861/0001104659-26-064861-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1838359/000110465926064861/tm2615300d1_8k.htm"},"side_by_side_evidence":null},{"accession":"0001651308-26-000012","ticker":"ONC","company_name":"BeOne Medicines Ltd.","filed_at":"2026-05-15T20:08:07+00:00","headline":"BeOne Medicines gets FDA accelerated approval for BEQALZI (sonrotoclax) in R/R MCL","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001651308-26-000012","json":"https://secwatch.observer/filing/0001651308-26-000012.json","markdown":"https://secwatch.observer/filing/0001651308-26-000012.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1651308/000165130826000012/0001651308-26-000012-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1651308/000165130826000012/bgne-20260513.htm"},"side_by_side_evidence":null},{"accession":"0001193125-26-224069","ticker":"AARD","company_name":"Aardvark Therapeutics, Inc.","filed_at":"2026-05-14T20:15:34+00:00","headline":"FDA places full clinical hold on Aardvark's ARD-101 IND; HERO and OLE trials paused","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.9,"calibrated_materiality_score":0.9,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-224069","json":"https://secwatch.observer/filing/0001193125-26-224069.json","markdown":"https://secwatch.observer/filing/0001193125-26-224069.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1774857/000119312526224069/0001193125-26-224069-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1774857/000119312526224069/ck0001774857-20260514.htm"},"side_by_side_evidence":null},{"accession":"0001140361-26-021036","ticker":"BBIO","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-05-13T20:01:37+00:00","headline":"BridgeBio submits NDA to FDA for encaleret in ADH1; Phase 3 data shows 76% achieved target calcium levels","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.8,"calibrated_materiality_score":0.8,"match_reasons":["same SEC item: 8.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-021036","json":"https://secwatch.observer/filing/0001140361-26-021036.json","markdown":"https://secwatch.observer/filing/0001140361-26-021036.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/0001140361-26-021036-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/ef20073370_form8k.htm"},"side_by_side_evidence":null},{"accession":"0001193125-26-251517","ticker":"LESL","company_name":"Leslie's, Inc.","filed_at":"2026-06-01T20:28:42+00:00","headline":"Leslie's regains Nasdaq compliance for minimum market value of publicly held shares","event_type":"regulatory","sec_items":["8.01"],"materiality_score":0.7,"calibrated_materiality_score":0.7,"match_reasons":["same SEC item: 8.01","same event type: regulatory"],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-251517","json":"https://secwatch.observer/filing/0001193125-26-251517.json","markdown":"https://secwatch.observer/filing/0001193125-26-251517.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1821806/000119312526251517/0001193125-26-251517-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1821806/000119312526251517/lesl-20260529.htm"},"side_by_side_evidence":null}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}