Aldeyra Therapeutics NASDAQ: ALDX Chief Executive Todd Brady said the company expects near-term feedback from the U.S. Food and Drug Administration on its dry eye disease candidate reproxalap, following a third complete response letter tied to efficacy questions.
Aldeyra Therapeutics stock plunges 71% after the FDA issues a third CRL for the resubmitted reproxalap NDA for the treatment of dry eye disease.
Here is how Aldeyra Therapeutics, Inc. (ALDX) and Iovance Biotherapeutics (IOVA) have performed compared to their sector so far this year.
The consensus price target hints at a 65.8% upside potential for Aldeyra Therapeutics (ALDX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
Here is how Aldeyra Therapeutics, Inc. (ALDX) and ANI Pharmaceuticals (ANIP) have performed compared to their sector so far this year.
Aldeyra's Reproxalap is the core catalyst. The FDA will make its decision on this asset by March 16, 2026, after a procedural PDUFA extension. Reproxalap's Chamber Phase 3 trial met symptom endpoints with rapid, durable relief. However, the main risk is that the field trial missed the primary symptom endpoint while showing supportive signals.
Aldeyra Therapeutics, Inc. (ALDX) Discusses PDUFA Target Action Date Extension for Reproxalap in Dry Eye Disease Transcript
Aldeyra Therapeutics, Inc. ( ALDX ) Discusses Expansion of RASP Platform Into CNS Diseases and Update on Reproxalap for Dry Eye November 13, 2025 8:00 AM EST Company Participants Laura Nichols - Operations Manager Todd Brady - CEO, President & Director Adam Lazorchak Conference Call Participants Thomas Shrader - BTIG, LLC, Research Division Catherine Novack - JonesTrading Institutional Services, LLC, Research Division Clara Dong Yale Jen Presentation Operator Hello, and welcome, everyone, to the Aldeyra Therapeutics 2025 Research and Development Update Webcast. My name is Becky, and I'll be your operator today.
Innovation is at its peak in the Zacks Medical-Drugs industry. CPRX, ZVRA, TBPH, ALDX and LRMR may prove to be good additions to one's portfolio.
Aldeyra Therapeutics (ALDX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).
Aldeyra Therapeutics' Reproxalap is now on its third NDA, which was filed in June 2025. It supposedly fixes prior trial flaws. ALDX believes a potential FDA acceptance could set a PDUFA date for December 2025. After that, AbbVie may pay $100 million upfront and share US profits if Reproxalap wins approval, which should materially de-risk its eventual commercialization.
Aldeyra Therapeutics (NASDAQ:ALDX) shares plummeted more than 70% after the biotechnology company received a letter of refusal from the Food and Drug Administration (FDA) for its investigational dry eye disease therapy reproxalap. The company said the rejection was based on insufficient evidence of efficacy in treating ocular symptoms associated with dry eye disease.