---
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"
generated_at: "2026-06-10T12:10:07.607525+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# ARS Pharma receives FDA Complete Response Letter for neffy; plans appeal, resubmission H1 2024

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-237996
- JSON: https://secwatch.observer/filing/0001193125-23-237996.json
- Plain text: https://secwatch.observer/filing/0001193125-23-237996.txt

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