TRYNGOLZA (olezarsen) — Regulatory decision
Q4 2026
sNDA submission on track for the end of 2025 with approval anticipated in the fourth quarter of 2026Source filing
IONS biotech catalysts & pipeline
IONIS PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
bepirovirsen — PDUFA
Oct 26
The FDA has granted Priority Review of bepirovirsen, with a PDUFA action date of October 26, 2026.Source filing
ZANVASTRO (zilganersen) — NDA/BLA submission
2027
Ionis is working closely with Recordati on preparing regulatory submissions in Europe and Japan, which are expected in 2027.Source filing
Obudanersen — Topline data
H2 2027
Obudanersen, a potential treatment for Angelman syndrome, completed enrollment in the Phase 3 REVEAL study, with data anticipated in the second half of 2027Source filing