{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-241941","form_type":"8-K","ticker":"PHAT","cik":"0001783183","company_name":"Phathom Pharmaceuticals, Inc.","filed_at":"2023-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:35.216435+00:00","generated_at":"2026-06-10T08:47:38.156951+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Phathom submits NDA to FDA for vonoprazan as daily Non-Erosive GERD treatment","bullets":["NDA for vonoprazan as daily treatment for Non-Erosive GERD in adults submitted to FDA, supported by Phase 3 PHALCON-NERD-301 study.","Primary endpoint met: 45% (10 mg) and 44% (20 mg) heartburn-free days vs 28% placebo (p<0.0001).","20-week extension study showed 61-63% heartburn-free days for vonoprazan doses.","FDA review expected 10 months; potential Q3 2024 U.S. launch if approved.","Vonoprazan under review for Erosive GERD with PDUFA date Nov 17, 2023; Q4 2023 launch planned if approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-241941","json":"https://secwatch.observer/filing/0001193125-23-241941.json","markdown":"https://secwatch.observer/filing/0001193125-23-241941.md","text":"https://secwatch.observer/filing/0001193125-23-241941.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523241941/0001193125-23-241941-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523241941/d535060d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T08:47:38.156951+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"}