{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-139053","form_type":"8-K","ticker":"SPRY","cik":"0001671858","company_name":"ARS Pharmaceuticals, Inc.","filed_at":"2023-05-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.965496+00:00","generated_at":"2026-06-15T09:23:38.967062+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"ARS Pharma faces FDA AdCom on May 11 for neffy (intranasal epinephrine); PK/PD sufficiency debated","bullets":["FDA AdCom to discuss whether PK/PD data for ARS-1 (intranasal epinephrine) sufficiently establish efficacy for anaphylaxis; meeting scheduled May 11, 2023.","Development program relies on PK/PD similarity to injection products rather than clinical efficacy trials; FDA questions translatability to anaphylaxis patients.","FDA notes PK/PD discrepancy: ARS-1 has lower epinephrine PK than EpiPen but higher/more sustained SBP/PR response; ARS argues this supports efficacy.","Proposed dose: 2 mg intranasal (one spray) for adults and children ≥30 kg, with optional second dose after 10 minutes if needed.","Human factors validation studies support usability; committee asked to weigh benefit-risk considering needle-free alternative to injectable epinephrine."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-139053","json":"https://secwatch.observer/filing/0001193125-23-139053.json","markdown":"https://secwatch.observer/filing/0001193125-23-139053.md","text":"https://secwatch.observer/filing/0001193125-23-139053.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671858/000119312523139053/0001193125-23-139053-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671858/000119312523139053/d415087d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-15T09:23:38.967062+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"}