{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-047351","form_type":"8-K","ticker":"SPRY","cik":"0001671858","company_name":"ARS Pharmaceuticals, Inc.","filed_at":"2025-03-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.387264+00:00","generated_at":"2026-05-25T10:34:48.520474+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA approves ARS Pharma's neffy 1 mg for pediatric allergic reactions","bullets":["FDA approved neffy 1 mg (epinephrine nasal spray) on March 5, 2025 for children aged 4+ weighing 15-30 kg.","Approval based on trials showing PK/PD consistent with injectable epinephrine; adverse events mild/transient.","neffy 1 mg expected to be available in the U.S. by end of May 2025.","Follows prior FDA approval of neffy 2 mg (Aug 2024) for patients ≥30 kg and EU approval (Aug 2024).","Human factors studies show children as young as 10 and untrained individuals can administer effectively."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-047351","json":"https://secwatch.observer/filing/0001193125-25-047351.json","markdown":"https://secwatch.observer/filing/0001193125-25-047351.md","text":"https://secwatch.observer/filing/0001193125-25-047351.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671858/000119312525047351/0001193125-25-047351-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671858/000119312525047351/d831088d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T10:34:48.520474+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"}