secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2026-11-09T21:02:19+00:00
Accession:  0001193125-26-453537
Event type: regulatory
Sentiment:  negative
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000119312526453537/0001193125-26-453537-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000119312526453537/aldx-20261109.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-453537

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