{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-22-028687","form_type":"8-K","ticker":"PBYI","cik":"0001401667","company_name":"PUMA BIOTECHNOLOGY, INC.","filed_at":"2022-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:50.461529+00:00","generated_at":"2026-06-21T07:25:18.430371+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Puma presents Phase II TBCRC-022 data: neratinib+T-DM1 achieves CNS ORR 28-33% in HER2+ BCBM","bullets":["CNS objective response rate by RANO-BM: 33.3% (cohort 4A), 29.4% (4B), 28.6% (4C).","Response + stable disease ≥6 months: 50% (4A), 35.3% (4B), 33.3% (4C).","Intracranial activity observed including prior T-DM1 exposure, suggesting reversal of resistance.","Most common adverse event: diarrhea (grade 2 32%, grade 3 23%); prophylaxis required.","Data from prospective, multicenter Phase II study; presented at San Antonio Breast Cancer Symposium."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-22-028687","json":"https://secwatch.observer/filing/0001437749-22-028687.json","markdown":"https://secwatch.observer/filing/0001437749-22-028687.md","text":"https://secwatch.observer/filing/0001437749-22-028687.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1401667/000143774922028687/0001437749-22-028687-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1401667/000143774922028687/pbyi20221206_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T07:25:18.430371+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"}