---
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"
generated_at: "2026-05-25T10:34:48.520474+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA approves ARS Pharma's neffy 1 mg for pediatric allergic reactions

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-047351
- JSON: https://secwatch.observer/filing/0001193125-25-047351.json
- Plain text: https://secwatch.observer/filing/0001193125-25-047351.txt

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