Aldeyra shares surge 30.33% intraday as FDA extends reproxalap PDUFA date to March 2026 following CSR submission.

Aldeyra Therapeutics surged 30.33% intraday following the FDA’s extension of the PDUFA target action date for reproxalap’s New Drug Application to March 16, 2026. The extension, triggered by the FDA’s request for a Clinical Study Report (CSR) from a dry eye disease field trial, was accompanied by key updates: the CSR, previously submitted under the IND, was deemed a major NDA amendment, and the FDA shared a draft label. While the field trial missed its primary endpoint, the agency raised no additional concerns and outlined a February 2026 timeline for labeling discussions. The market interpreted the structured regulatory path and absence of new hurdles as positive, outweighing concerns over the delayed timeline.