Aldeyra Extends PDUFA Date for Dry Eye Drug Application to March 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
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Source: Newsfilter
- Review Date Extension: The FDA has extended the PDUFA target action date for Aldeyra's dry eye drug application to March 16, 2026, indicating ongoing review processes that may impact market expectations and investor confidence in Aldeyra.
- Clinical Trial Results: Although the clinical trial for dry eye disease supports the activity of reproxalap, it failed to meet the primary endpoint of improving dry eye symptoms, which could negatively affect market acceptance and future sales of the drug.
- Regulatory Communication: During the December 12, 2025 meeting, the FDA did not raise additional requests, suggesting a relatively smooth review process for the NDA, but attention is needed on the FDA's final labeling requirements, which could influence post-market performance.
- Investor Call Arrangement: Aldeyra plans to host a conference call on December 16, 2025, to discuss the PDUFA extension, providing an opportunity for investor communication that may help alleviate market concerns regarding the delay.
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Analyst Views on ALDX
Wall Street analysts forecast ALDX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ALDX is 9.50 USD with a low forecast of 9.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 5.420
Low
9.00
Averages
9.50
High
10.00
Current: 5.420
Low
9.00
Averages
9.50
High
10.00
About ALDX
Aldeyra Therapeutics, Inc. is a biotechnology company focused on discovering therapies designed to treat immune-mediated and metabolic diseases. The Company's approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Its product candidates include reactive aldehyde species (RASP) modulators ADX-629, ADX 248, ADX-743, ADX-631, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Its late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa. ADX 629 is in Phase II clinical trials for moderate alcohol-associated hepatitis and Sjogren-Larsson Syndrome.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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FDA Prolongs Review Period for Aldeyra's Drug for Dry Eye Disease
FDA Action on Aldeyra's NDA: The FDA has extended the target action date for Aldeyra Therapeutics' New Drug Application (NDA) for reproxalap, a treatment for dry eye disease, to March 16, 2026, following a request for additional clinical data.
Clinical Trial Results: The field trial for reproxalap did not meet its primary endpoint of improving dry eye symptoms compared to the vehicle control, despite being supportive of the drug's activity.
Regulatory Review Process: Aldeyra submitted a Clinical Study Report (CSR) as a major amendment to the NDA, and the FDA plans to communicate any proposed labeling requests by February 16, 2026, if no major deficiencies are found.
Stock Market Reaction: Following the FDA's announcement, Aldeyra Therapeutics' stock fell by 12.1% to $3.99, with a further decline of 1.5% in premarket trading.
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