---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-405954"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2026-09-29T11:01:15+00:00"
generated_at: "2026-10-12T13:41:26.440746+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Aldeyra to appeal FDA's March 16 CRL for reproxalap dry eye; cash runway extended to 2029

## Summary
- Plans Formal Dispute Resolution Request to FDA's Office of New Drugs appealing the March 16, 2026 Complete Response Letter denying approval of reproxalap for dry eye disease.
- FDRR submission and OND meeting expected in Q4 2026; FDA has issued three CRLs for reproxalap after the original NDA and two resubmissions.
- Most recent CRL did not request further trials but said totality of evidence from completed trials does not support effectiveness; prior two CRLs recommended an additional clinical trial.
- Aldeyra cites data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints.
- Reported $45.1M cash and equivalents as of June 30, 2026; projected operational cash runway extended into 2029.

## SEC filing metadata
- accession: 0001193125-26-405954
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2026-09-29T11:01:15+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000119312526405954/0001193125-26-405954-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000119312526405954/aldx-20260929.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-405954
- JSON: https://secwatch.observer/filing/0001193125-26-405954.json
- Plain text: https://secwatch.observer/filing/0001193125-26-405954.txt

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