FDA Issues Second Complete Response Letter for Reproxalap

Aldeyra Therapeutics ( (ALDX) ) has shared an update.

On March 17, 2026, Aldeyra Therapeutics announced that the U.S. Food and Drug Administration issued a Complete Response Letter rejecting the New Drug Application for reproxalap in dry eye disease, citing a lack of substantial evidence of efficacy, inconsistent study results, and concerns over the reliability and meaningfulness of positive findings, although no safety or manufacturing issues were raised. The decision followed a prior Complete Response Letter in April 2025 and subsequent additional trials and resubmissions, and while Aldeyra plans to seek a Type A meeting with the FDA to clarify a path forward without conducting new trials, the setback raises significant uncertainty over eventual approval and commercialization of reproxalap, even as the company reports $70 million in cash and securities expected to fund operations into 2028.

Aldeyra previously received a Complete Response Letter in April 2025 for reproxalap over inadequate evidence of efficacy and then ran an additional dry eye chamber trial that met its primary endpoint, resubmitting the NDA in June 2025 before the FDA again determined in March 2026 that the totality of evidence did not support effectiveness in treating signs and symptoms of dry eye disease. The FDA recommended Aldeyra analyze reasons for trial failures and identify patient populations or conditions where reproxalap might work, and the company has warned that any future requirement for additional studies or trials could increase costs, delay any potential approval, and have a material adverse effect on its business and financial condition.

The most recent analyst rating on (ALDX) stock is a Sell with a $4.00 price target. To see the full list of analyst forecasts on Aldeyra Therapeutics stock, see the ALDX Stock Forecast page.

Spark’s Take on ALDX Stock

According to Spark, TipRanks’ AI Analyst, ALDX is a Neutral.

The score is held down primarily by weak financial performance (no revenue, ongoing losses, and elevated recent cash burn) and bearish technicals (price below key moving averages with negative MACD). A negative P/E provides limited valuation insight due to lack of profitability, and a recent FDA PDUFA extension adds additional near-term regulatory/timeline uncertainty.

To see Spark’s full report on ALDX stock, click here.

More about Aldeyra Therapeutics

Aldeyra Therapeutics, Inc. is a biotechnology company focused on discovering and developing innovative therapies for immune-mediated diseases by modulating protein systems rather than targeting single proteins. Its pipeline includes RASP modulators such as ADX‑248 and ADX‑246 for systemic and retinal conditions, and late-stage candidates reproxalap for dry eye disease and allergic conjunctivitis, and ADX‑2191 for primary vitreoretinal lymphoma and retinitis pigmentosa.

Average Trading Volume: 1,001,359

Technical Sentiment Signal: Sell

Current Market Cap: $254.6M

Learn more about ALDX stock on TipRanks’ Stock Analysis page.