Dupixent (dupilumab) — Regulatory decision
H2 2026
EC decision on regulatory submission for bullous pemphigoid (second half 2026)Source filing
REGN biotech catalysts & pipeline
REGENERON PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
Pozelimab — Topline data
H2 2026
Report initial results from lead-in cohort of Phase 3 study in geographic atrophy (combination and cemdisiran monotherapy) (second half 2026)Source filing
Trevogrumab — Interim data
H2 2026
Report additional data from Phase 2 study in obesity (second half 2026)Source filing
EYLEA HD — Regulatory decision
Late 2026
The Company is working with the FDA and multiple third-party filling manufacturers to potentially achieve regulatory approval for the pre-filled syringe by the end of 2026.Source filing
Cemdisiran — Topline data
Q4 2026
Report results from Phase 3 study in PNH (fourth quarter 2026)Source filing
Fianlimab — Topline data
Q4 2026
Report results from Phase 3 study versus pembrolizumab in adjuvant melanoma (fourth quarter 2026)Source filing
Pozelimab + cemdisiran — Topline data
Oct 2026–Mar 2027
Report results from Phase 3 study in PNH (fourth quarter 2026/first quarter 2027)Source filing
cemdisiran — PDUFA
Nov 2026
The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher.Source filing
Garetosmab — Regulatory decision
H1 2027
FDA decision on Biologics License Application ("BLA") (August 2026) and EC decision on Marketing Authorization Application ("MAA") (first half 2027) for FOPSource filing
Otarmeni — Regulatory decision
Q1 2027
EC decision on MAA for hearing loss associated with variants in OTOF gene (first quarter 2027)Source filing
cemdisiran — Regulatory decision
H2 2027
A decision from the European Commission is anticipated in the second half of 2027.Source filing