---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-453537"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2026-11-09T21:02:19+00:00"
generated_at: "2026-11-09T21:03:10.588592+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Aldeyra seeks FDA transfer of ADX-2191 PVRL review, withdraws SPA protocol

## Summary
- Aldeyra asked FDA's Division of Ophthalmology to submit a jurisdiction request to OND to move the ADX-2191 IND for PVRL to the Division of Hematologic Malignancies 2.
- Company notified FDA it withdrew the Special Protocol Assessment protocol for ADX-2191 in PVRL that the Division of Ophthalmology had reviewed and agreed to.
- Aldeyra does not expect to initiate the SPA-contemplated trial while the request is pending and expects the PVRL program will need to be redesigned.
- Context: FDA issued a Complete Response Letter in June 2023 for the ADX-2191 PVRL NDA, citing lack of substantial evidence of effectiveness.
- Company warns a redesign may be larger, longer and costlier, could delay orphan drug exclusivity, shorten cash runway and require raising capital sooner.

## SEC filing metadata
- accession: 0001193125-26-453537
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2026-11-09T21:02:19+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000119312526453537/0001193125-26-453537-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000119312526453537/aldx-20261109.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-453537
- JSON: https://secwatch.observer/filing/0001193125-26-453537.json
- Plain text: https://secwatch.observer/filing/0001193125-26-453537.txt

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