ALDX 8-K: Regulatory action

Filed with the SEC on · accession 0001193125-26-453537

ALDX filed a 8-K (current report) with the SEC on Nov 9, 2026. Aldeyra Therapeutics requested that the FDA's Division of Ophthalmology transfer review of its ADX-2191 IND for primary vitreoretinal lymphoma to the Division of Hematologic Malignancies 2, and withdrew its previously agreed Special Protocol Assessment protocol. The stock moved +0.4% by the first close after the filing.

Summary of the filing

Aldeyra Therapeutics requested that the FDA's Division of Ophthalmology transfer review of its ADX-2191 IND for primary vitreoretinal lymphoma to the Division of Hematologic Malignancies 2, and withdrew its previously agreed Special Protocol Assessment protocol. The regulatory path for ADX-2191 in PVRL is now uncertain and may be significantly delayed, and the company does not expect to initiate the planned clinical trial while the request is pending.

Key details

RegistrantAldeyra Therapeutics, Inc.
RegulatorU.S. Food and Drug Administration

How ALDX stock reacted

Close before

$0.63

Nov 6, 2026

First close after

+0.36%

$0.64

5 trading days

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Since filing

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Frequently asked questions

What did ALDX file with the SEC on Nov 9, 2026?

ALDX filed a 8-K (Regulatory action). Aldeyra Therapeutics requested that the FDA's Division of Ophthalmology transfer review of its ADX-2191 IND for primary vitreoretinal lymphoma to the Division of Hematologic Malignancies 2, and withdrew its previously agreed Special Protocol Assessment protocol. The regulatory path for ADX-2191 in PVRL is now uncertain and may be significantly delayed, and the company does not expect to initiate the planned clinical trial while the request is pending.

What does a regulatory action mean for ALDX stock?

A settlement removes uncertainty; the stock often reacts to whether the amount is bigger or smaller than investors expected.

How do I read a 8-K?

A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more. The "Item" number tells you the topic (e.g. 2.02 results, 5.02 executive change, 1.01 new agreement, 1.03 bankruptcy). Exhibits (99.1 press release) usually hold the details.

Why are SEC filings important?

Public companies must tell the SEC about anything that can change their value — results, leadership changes, big deals, new shares, bankruptcy. Filings are the official source, often before the news. A 8-K (current report): A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more.

How did ALDX stock react to this filing?

ALDX closed at $0.63 before the filing and $0.64 on Nov 9, 2026 (+0.36%).

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