{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-151785","form_type":"8-K","ticker":"PHAT","cik":"0001783183","company_name":"Phathom Pharmaceuticals, Inc.","filed_at":"2023-05-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.548333+00:00","generated_at":"2026-06-14T17:27:48.346519+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Phathom resubmits NDA for vonoprazan for erosive GERD with stability data controlling nitrosamine impurity","bullets":["Resubmitted vonoprazan NDA for erosive GERD to FDA after February 2023 Complete Response Letter.","Stability data from six reformulated batches show NVP levels >10-fold below 96 ng/day intake limit through 3 months.","NDA classified as Class 2 resubmission with 6-month review; 6-month stability data to be provided during review.","If approved, combined U.S. commercial launch for erosive GERD and H. pylori indications planned for Q4 2023.","Phase 3 PHALCON-EE trial enrolled 1,024 patients; compared vonoprazan to lansoprazole."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-151785","json":"https://secwatch.observer/filing/0001193125-23-151785.json","markdown":"https://secwatch.observer/filing/0001193125-23-151785.md","text":"https://secwatch.observer/filing/0001193125-23-151785.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523151785/0001193125-23-151785-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523151785/d503681d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T17:27:48.346519+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"}