The U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target action date for Aldeyra Therapeutics’ reproxalap New Drug Application (NDA) to March 16 2026, giving the company an additional three months to address any remaining questions and submit final data.
The extension follows a meeting on December 12, 2025, during which the FDA requested the submission of the Clinical Study Report (CSR) for a dry eye disease field trial. Aldeyra complied by filing the CSR on the same day, and the FDA indicated that no further major deficiencies were identified.
The field‑trial data that prompted the request did not meet its primary endpoint of improvement in dry eye symptoms relative to vehicle control, but the results were considered supportive of reproxalap’s activity. The FDA’s request for the CSR and its classification as a major amendment signal ongoing efficacy concerns that the company must address before approval can be granted.
The extension delays the potential approval of reproxalap, postponing the $100 million upfront payment and up to $300 million in milestones that would be earned under the exclusive option agreement with AbbVie. It also delays the launch of Aldeyra’s first revenue‑generating product, a key catalyst for the company’s financial trajectory.
Following the announcement, Aldeyra’s shares fell 12 % in pre‑market trading, closed at $3.99 on Monday, and dropped further to $3.32 in after‑hours trading. The decline reflects investor concern about the regulatory risk and the extended timeline to potential revenue.
Aldeyra’s Q3 2025 earnings report showed an earnings per share of –$0.13, beating analyst expectations of –$0.17 and improving from –$0.25 in the same quarter a year earlier. The company remains a clinical‑stage biopharma with no current revenue, relying on future product approvals and a substantial cash reserve to fund research and development.
CEO Todd C. Brady emphasized that the company remains focused on meeting FDA requirements and advancing the AbbVie partnership. He noted that the company is committed to addressing the agency’s concerns and that the partnership remains a critical source of future funding and commercialization expertise.
The PDUFA extension underscores the continued scrutiny of reproxalap’s efficacy profile. Investors and analysts will watch the next FDA meeting closely, as the timeline for approval and the activation of the AbbVie deal remain uncertain.
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