{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-237996","form_type":"8-K","ticker":"SPRY","cik":"0001671858","company_name":"ARS Pharmaceuticals, Inc.","filed_at":"2023-09-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.799543+00:00","generated_at":"2026-06-10T12:10:07.607525+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"ARS Pharma receives FDA Complete Response Letter for neffy; plans appeal, resubmission H1 2024","bullets":["FDA CRL requests a repeat-dose PK/PD study in allergen-induced allergic rhinitis conditions for approval.","Company will file a Formal Dispute Resolution Request to appeal the CRL; advisory committee voted 16-6/17-5 in favor May 2023.","CRL also asks for nitrosamine impurity testing; company says not rate-limiting for resubmission.","Resubmission expected first half 2024 with FDA action target second half 2024.","Prior FDA alignment on the repeat-dose study as a post-marketing commitment; CRL now requires it for approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-237996","json":"https://secwatch.observer/filing/0001193125-23-237996.json","markdown":"https://secwatch.observer/filing/0001193125-23-237996.md","text":"https://secwatch.observer/filing/0001193125-23-237996.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671858/000119312523237996/0001193125-23-237996-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671858/000119312523237996/d556858d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T12:10:07.607525+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"}