{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-198384","form_type":"8-K","ticker":"SPRY","cik":"0001671858","company_name":"ARS Pharmaceuticals, Inc.","filed_at":"2024-08-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.045872+00:00","generated_at":"2026-05-31T10:04:36.765601+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves ARS Pharma's neffy epinephrine nasal spray for allergic reactions","bullets":["FDA approved neffy on Aug 9, 2024 for emergency treatment of anaphylaxis in adults and children ≥30 kg.","Approval based on five registration studies showing pharmacokinetic/pharmacodynamic data within range of approved injectable epinephrine.","neffy expected to be available in US within 8 weeks; plan to file sNDA for children 15-<30 kg by end of Q3 2024.","CHMP positive opinion in EU on June 27; EMA decision expected Q3 2024; European commercial launch expected Q4 2024 via partner."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-198384","json":"https://secwatch.observer/filing/0001193125-24-198384.json","markdown":"https://secwatch.observer/filing/0001193125-24-198384.md","text":"https://secwatch.observer/filing/0001193125-24-198384.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671858/000119312524198384/0001193125-24-198384-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671858/000119312524198384/d844683d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T10:04:36.765601+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"}