givosiran — NDA/BLA submission
2026
Regulatory filings for givosiran (the generic name of GIVLAARI) in additional territories are pending or planned during 2026 and beyond.Source filing
ALNY biotech catalysts & pipeline
ALNYLAM PHARMACEUTICALS INC · Data as of 2026-10-25
Upcoming catalysts
lumasiran — NDA/BLA submission
2026
OXLUMO has also been approved in several other countries and regulatory filings for lumasiran (the generic name of OXLUMO) in additional territories are pending or planned during 2026 and beyond.Source filing
ALN-2232 — Clinical data readout
H2 2026
In the second half of 2026, Alnylam expects to announce clinical data from additional pipeline programs, including: ... Results from a Phase 1 clinical trial of ALN-2232 in obesity and weight management.Source filing
ALN-6400 — Initial data
H2 2026
In late 2025, we initiated a Phase 2 clinical trial of ALN-6400 in patients with Hereditary Hemorrhagic Telangiectasia, or HHT, and we plan to share additional data from the Phase 1 clinical trial as well as initial results in the Phase 2 clinical trial in HHT the second half of 2026.Source filing
cemdisiran — PDUFA
Nov 2026
Regeneron indicated that 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, and that a decision from the European Commission is anticipated in the second half of 2027.Source filing
cemdisiran — Regulatory decision
H2 2027
Regeneron indicated that 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, and that a decision from the European Commission is anticipated in the second half of 2027.Source filing
nucresiran — Topline data
2028
Topline results are expected in 2028.Source filing