---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-072424"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2025-04-03T23:59:59+00:00"
generated_at: "2026-05-23T22:22:37.049542+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Aldeyra's reproxalap dry eye NDA; additional study required

## Summary
- FDA CRL states reproxalap 'failed to demonstrate efficacy' in adequate studies; no safety or manufacturing issues.
- Type A meeting expected within ~30 days; top-line data from ongoing chamber and field trials due Q2 2025.
- Aldeyra plans NDA resubmission mid-2025 pending positive results and FDA discussions; review period expected 6 months.
- Cash, equivalents, and marketable securities $101M as of Dec 31, 2024; 2025 trial costs ~$6M.

## SEC filing metadata
- accession: 0001193125-25-072424
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2025-04-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000119312525072424/0001193125-25-072424-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000119312525072424/d946200d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-072424
- JSON: https://secwatch.observer/filing/0001193125-25-072424.json
- Plain text: https://secwatch.observer/filing/0001193125-25-072424.txt

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