Top News

• The FDA delayed its decision on the dry eye drug Reproxalap without raising new issues.
• The FDA pushed the PDUFA deadline to March 16, 2026, after requesting a clinical study report already reviewed under an earlier filing.
• Regulatory progress continued, with the FDA sharing a draft label and outlining next steps.

Aldeyra Therapeutics shares jumped on Tuesday, heading for their best day in more than eight months, after the U.S. Food and Drug Administration (FDA) extended its review of the company’s dry eye drug without flagging any new issues.

Add Asianet Newsable as a Preferred Source

The stock rose 31% to hit $5.22 at the time of writing.

FDA Timeline

Aldeyra Therapeutics said the FDA has pushed back its decision deadline on Reproxalap, the company’s dry eye drug, to March 16, 2026. The deadline, known as the Prescription Drug User Fee Act target action date, had previously been set for Dec. 16.

The extension follows a Dec. 12 meeting between the FDA and the company, during which the agency requested submission of a Clinical Study Report for a dry eye disease field trial. Aldeyra said the report was submitted to the NDA on the same day and was classified by the FDA as a major amendment, triggering the three-month extension.

Scope Of The FDA Request

The company said the FDA made no other requests at the December meeting and did not identify any additional issues with the NDA review. The Clinical Study Report had already been reviewed by the FDA under the drug’s Investigational New Drug file.

Aldeyra also said safety data from the field trial had been submitted earlier, in August, at the FDA’s request during the NDA review process.

The field trial, for which top-line results were announced in May, did not meet its primary endpoint of improving dry eye symptoms compared with a vehicle control. The company said the trial was supportive of the activity of the drug relative to the vehicle and had been discussed with the FDA before the NDA submission.

Labeling Progress 

Earlier this month, the FDA shared a draft of the proposed label for the dry eye drug with Aldeyra, and the company said it has submitted a response. According to Aldeyra, the FDA indicated that if no major deficiencies are identified during the extended review period, the agency plans to communicate proposed labeling requests and any anticipated postmarketing requirements by Feb. 16, 2026.

Aldeyra said the NDA was originally submitted on June 16, and was accepted for review as a complete class 2 response in July.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment for Aldeyra was ‘extremely bullish’ amid ‘extremely high’ message volume.

One bullish user expects the stock to “keep rising during the day.”

Another user said, “Abbvie buy this bad boy out!”

Aldeyra’s stock has risen 4% so far in 2025.

For updates and corrections, email newsroom[at]stocktwits[dot]com.<