regulatory
confidence high
sentiment positive
materiality 0.80
Aldeyra's reproxalap NDA accepted by FDA with April 2, 2025 PDUFA; expands AbbVie option deal
Aldeyra Therapeutics, Inc.
- FDA accepted resubmitted NDA for reproxalap for dry eye disease; PDUFA date April 2, 2025.
- Expanded option with AbbVie: upon exercise, AbbVie pays $100M upfront (less $6M fees) plus up to $300M milestones.
- If option exercised, profit/loss split 60% AbbVie, 40% Aldeyra; Aldeyra pre-commercial costs 60% reimbursed by AbbVie.
- Option exercise period amended to 10 business days after FDA approval of reproxalap for dry eye disease.