Aldeyra plans FDA dispute request for reproxalap

What happened

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) said it intends to submit a Formal Dispute Resolution Request to the FDA for reproxalap in dry eye disease. The request is meant to appeal the March 16, 2026 complete response letter. The FDA’s Office of New Drugs is expected to review it.

Aldeyra said the request submission and a meeting with OND are expected in the fourth quarter of 2026. It also said $45.1 million in cash and cash equivalents as of June 30, 2026 support operational cash runway into 2029.

Key numbers

Metric	Latest	Change	Source
FDRR submission and OND meeting	fourth quarter of 2026		SEC 8-K
Cash and cash equivalents	$45.1 million		SEC 8-K
Operational cash runway	into 2029		SEC 8-K
Complete Response Letters	3 letters		SEC 8-K
Efficacy trials submitted	9 trials		SEC 8-K
Primary endpoints met	5 trials		SEC 8-K

Read more: Aldeyra Therapeutics (ALDX) stock analysis and investment case

Why it matters

OptimistFi’s case is that value depends on regulatory validation before cash burn forces financing. This filing adds a clear FDA appeal path and a longer cash horizon. That matters because the case still turns on approval odds.

Aldeyra said it has received three complete response letters for reproxalap. The first two recommended another clinical trial. The latest said the totality of evidence from completed clinical trials does not support effectiveness.

The company said it submitted data from nine adequate and well-controlled clinical trials. Five of the nine efficacy trials, or 55.6%, met all multiplicity-controlled primary endpoints, and that is the main data point behind the appeal.

Still, the latest complete response letter is the main risk. The filing says the most recent FDA response did not ask for more clinical trials and instead questioned the product’s effectiveness.

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What's next

Aldeyra said the FDRR submission and a meeting with OND are expected in the fourth quarter of 2026. It also said the timing of the OND decision will depend on whether the deciding official asks for more information, brings in internal or external experts, or convenes an advisory panel.

A favorable OND response would strengthen the case. An adverse response would weaken it. The fourth-quarter meeting is the next scheduled test of whether reproxalap moves closer to approval.

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