---
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"
generated_at: "2026-06-23T01:58:45.044302+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA accepts ARS Pharma's NDA for neffy (epinephrine nasal spray) for allergic reactions

## Summary
- 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).

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-266351
- JSON: https://secwatch.observer/filing/0001193125-22-266351.json
- Plain text: https://secwatch.observer/filing/0001193125-22-266351.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.