USFDAJul 15, 2026, 04:52 PM
Aldeyra Receives FDA Minutes on Reproxalap NDA Resubmission
AI Summary
Aldeyra Therapeutics received minutes from a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the potential resubmission of its New Drug Application (NDA) for reproxalap for dry eye disease. The company has requested clarification of these minutes and plans to request a Type D meeting with the FDA to further discuss the NDA resubmission. This Type D meeting is anticipated to occur by the end of the third quarter of 2026.
Key Highlights
- Received FDA minutes on July 14, 2026, from a June 10, 2026 Type A meeting.
- Meeting concerned potential resubmission of reproxalap NDA for dry eye disease.
- Requested clarification of the minutes from the FDA on July 15, 2026.
- Intends to request a Type D meeting with the FDA.
- Type D meeting expected by end of Q3 2026.
Price Impact
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