---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-319638"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2025-12-16T23:59:59+00:00"
generated_at: "2026-05-16T13:01:02.182011+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Aldeyra: FDA extends reproxalap PDUFA to March 16, 2026 after requesting failed trial report

## Summary
- PDUFA target action date extended three months to March 16, 2026 from original Dec 16, 2025.
- FDA requested CSR of dry eye field trial that missed primary endpoint; CSR submitted Dec 12 as major amendment.
- FDA shared draft label in early December; Aldeyra responded; labeling and postmarketing plans expected by Feb 16, 2026.
- No other specific issues or requests identified by FDA during review.
- Field trial top-line results announced May 5, 2025; safety data previously submitted Aug 21, 2025.

## SEC filing metadata
- accession: 0001193125-25-319638
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2025-12-16T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000119312525319638/0001193125-25-319638-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000119312525319638/aldx-20251215.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-319638
- JSON: https://secwatch.observer/filing/0001193125-25-319638.json
- Plain text: https://secwatch.observer/filing/0001193125-25-319638.txt

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