Pharma BD Deal Intelligence
Aldeyra and AbbVie entered an exclusive option agreement for reproxalap (a reactive aldehyde species modulator) on October 31, 2023. Upon option exercise, AbbVie would pay $100M upfront (less $6M in prior option fees) for a co-exclusive U.S. license plus an exclusive ex-U.S. license, with Aldeyra eligible for up to $300M in regulatory/commercial milestones, a 60/40 U.S. profit share to AbbVie, and tiered ex-U.S. royalties. The parties EXPANDED the agreement on November 18, 2024 (concurrent with FDA acceptance of the dry-eye NDA): they added pre-commercial cost-sharing (60% AbbVie / 40% Aldeyra), a $100M milestone contingent on FDA approval, and amended the option to expire 10 business days following any FDA approval of reproxalap for dry eye disease. The deal's economics never triggered: the reproxalap dry-eye program drew three Complete Response Letters (November 2023, April 2025, and a third on March 17, 2026 citing a lack of substantial evidence of efficacy, which sent Aldeyra shares down ~65% and spawned securities class actions). As of Aldeyra's February 27, 2026 10-K and its March 2026 8-K, AbbVie had NOT exercised the option and had NOT terminated the agreement; exercise remains contingent on an FDA approval that has not occurred, leaving the deal pending and increasingly imperiled.