Aldeyra Therapeutics (ALDX) saw its shares drop approximately 12% in premarket trading following news of a potential delay in the FDA's review of its lead drug, reproxalap, for dry eye disease. The FDA has extended the Prescription Drug User Fee Act (PDUFA) date to March 16, 2026, from the previously set December 16, 2025. This extension comes after Aldeyra submitted a clinical study report, considered a major amendment, which did not meet the primary goal of symptom improvement. The FDA has provided a draft label, indicating potential progress if no major issues arise.
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