{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-266351","form_type":"8-K","ticker":"SPRY","cik":"0001671858","company_name":"ARS Pharmaceuticals, Inc.","filed_at":"2022-10-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.652828+00:00","generated_at":"2026-06-23T01:58:45.044302+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA accepts ARS Pharma's NDA for neffy (epinephrine nasal spray) for allergic reactions","bullets":["FDA accepted NDA for neffy (epinephrine nasal spray) for emergency treatment of allergic reactions including anaphylaxis in adults and children ≥30 kg.","If approved, neffy would be first non-injectable treatment for type I allergic reactions in U.S.","PDUFA target action date anticipated in mid-2023.","NDA based on four registration studies showing pharmacokinetics comparable to injectable epinephrine; well-tolerated in over 500 individuals.","Acceptance is a milestone for Silverback's proposed merger with ARS Pharma (previously announced)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-266351","json":"https://secwatch.observer/filing/0001193125-22-266351.json","markdown":"https://secwatch.observer/filing/0001193125-22-266351.md","text":"https://secwatch.observer/filing/0001193125-22-266351.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671858/000119312522266351/0001193125-22-266351-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671858/000119312522266351/d305402d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T01:58:45.044302+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"}