FDA Accepts Aldeyra's Resubmitted NDA For Reproxalap For Treatment Of Dry Eye Disease
FDA Acceptance: Aldeyra Therapeutics announced that the FDA has accepted their resubmitted New Drug Application for reproxalap, aimed at treating dry eye disease.
Clinical Trial Requirement: The NDA resubmission included a clinical trial that met the primary endpoint of reducing ocular discomfort, with a decision from the FDA expected by December 16, 2025.
Get Free Real-Time Notifications for Any Stock
Analyst Views on ALDX
About ALDX
About the author
Healthcare Stocks with Strong Earnings Momentum Earn A+ EPS Revision Grades
- Investor Attention: As the earnings season unfolds, mid to low market capitalization healthcare stocks are drawing investor attention due to their strong earnings momentum, indicating growing market confidence in this sector.
- Analyst Expectations: The EPS Revision Grade reflects the trend in analyst earnings estimates, with A+ ratings indicating optimistic projections for future performance, potentially driving stock prices higher.
- List of A+ Rated Stocks: Currently, companies such as Aldeyra Therapeutics, Altimmune, Annovis Bio, and Assertio Holdings have received A+ EPS Revision Grades, showcasing their strong performance in the eyes of analysts.
- Market Strategy Impact: These A+ rated healthcare stocks are likely to attract more investor interest, potentially triggering positive sentiment towards the healthcare sector as a whole, thereby enhancing the performance of related ETFs.
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.
