Eye disease
ALVOAlvotechCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Mynzepli® (AVT06, a Proposed Biosimilar to Eylea®) (aflibercept) in Eye disease . The expected timing is based on the latest available company guidance and may change.
Collab with TEVA. 2/18/25- BLA accepted. Regulatory approval in Q4 2025. 6/23/25- CHMP positive opinion. 8/21/25- European approval for Mynzepli®. 03/18/26:- Eylea biosimilar confirmed among five approved and marketed biosimilars in global markets. 05/06/26:- PR No update. 06/04/26:- AVT06 BLA resubmitted; FDA expects six-month review. PDUFA decision expected December 2026 (Est). 08/19/26:- AVT06 U.S. BLA resubmission was reiterated. FDA decision is anticipated in Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.