Aldeyra Therapeutics shares rise 32.08% after hours as FDA delays Reproxalap decision to March 2026 without raising new issues.
ByAinvest
Tuesday, Dec 16, 2025 4:36 pm ET1min read
ALDX--
Aldeyra Therapeutics surged 32.08% in after-hours trading following the FDA’s extension of the PDUFA review date for its dry eye drug Reproxalap to March 16, 2026. The delay, triggered by the FDA’s request for a previously reviewed clinical study report, was classified as a major amendment but did not introduce new issues. The agency shared a draft label and outlined next steps, signaling continued regulatory progress. Despite the extension, the absence of new concerns and ongoing dialogue with the FDA alleviated investor fears, fueling the sharp post-market rally. The stock’s performance contrasts with a pre-market decline mentioned in some reports, likely reflecting evolving interpretations of the FDA’s feedback during the day.
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue

Comments
No comments yet