{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-274876","form_type":"8-K","ticker":"PHAT","cik":"0001783183","company_name":"Phathom Pharmaceuticals, Inc.","filed_at":"2024-12-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.605313+00:00","generated_at":"2026-05-29T04:46:00.986118+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Phathom files Citizen Petition to correct VOQUEZNA Orange Book exclusivity to May 2032","bullets":["Petition requests FDA correct VOQUEZNA tablet listings to reflect 10-year NCE exclusivity ending May 3, 2032.","Exclusivity stems from GAIN Act extension on vonoprazan, already applied to VOQUEZNA DUAL/TRIPLE PAK approved May 2022.","FDA must respond within 180 days; may approve, deny, or provide tentative response.","Corrected listing would block ANDA or 505(b)(2) submissions referencing vonoprazan until expiry.","Phathom expects CP docket to appear on regulations.gov in coming days."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-274876","json":"https://secwatch.observer/filing/0001193125-24-274876.json","markdown":"https://secwatch.observer/filing/0001193125-24-274876.md","text":"https://secwatch.observer/filing/0001193125-24-274876.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1783183/000119312524274876/0001193125-24-274876-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1783183/000119312524274876/d904037d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T04:46:00.986118+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"}