---
schema_version: "secwatch.filing_event.v1"
accession: "0001157523-23-000387"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2023-03-02T23:59:59+00:00"
generated_at: "2026-06-18T14:40:40.272365+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Aldeyra's NDA for ADX-2191 with Priority Review; PDUFA June 21, 2023

## Summary
- FDA accepted NDA for ADX-2191 (methotrexate injection) for primary vitreoretinal lymphoma with Priority Review.
- PDUFA date set for June 21, 2023; FDA noted no potential filing review issues identified.
- Planned U.S. launch in second half of 2023, pending FDA approval.
- NDA supported by over 30 years of published literature and safety data from Phase 3 GUARD Trial.
- ADX-2191 has potential to be first FDA-approved drug for primary vitreoretinal lymphoma.

## SEC filing metadata
- accession: 0001157523-23-000387
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2023-03-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000115752323000387/0001157523-23-000387-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000115752323000387/a53354388.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001157523-23-000387
- JSON: https://secwatch.observer/filing/0001157523-23-000387.json
- Plain text: https://secwatch.observer/filing/0001157523-23-000387.txt

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