---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-109511"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2026-03-17T23:59:59+00:00"
generated_at: "2026-05-15T10:16:45.870813+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA issues second Complete Response Letter for Aldeyra's reproxalap NDA; efficacy concerns cited

## Summary
- CRL states 'lack of substantial evidence' and 'failed to demonstrate efficacy' for dry eye disease signs and symptoms.
- No safety or manufacturing concerns identified; FDA did not recommend additional trials or confirmatory evidence.
- Aldeyra intends to request Type A meeting within 30 days to determine next steps for approval.
- Cash and marketable securities of $70M as of Dec 31, 2025 expected to fund operations into 2028.

## SEC filing metadata
- accession: 0001193125-26-109511
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2026-03-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000119312526109511/0001193125-26-109511-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000119312526109511/aldx-20260317.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-109511
- JSON: https://secwatch.observer/filing/0001193125-26-109511.json
- Plain text: https://secwatch.observer/filing/0001193125-26-109511.txt

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