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 2026-09-08
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 — Topline data
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 — Topline data
H2 2026
In the second half of 2026, Alnylam expects to announce clinical data from additional pipeline programs, including: • Results from Phase 1 and Phase 2 clinical trials of ALN-6400 in healthy volunteers and patients with hereditary hemorrhagic telangiectasia (HHT), respectively.Source filing
ALN-HTT02 — Initial data
Oct 23
Alnylam announces today that it will present initial results from the Phase 1 clinical trial of ALN-HTT02 in patients with Huntington's disease at the European Huntington's Disease Network (EHDN) Clinical Research Congress on Friday, October 23, 2026, in Kraków, Poland.Source filing
cemdisiran — PDUFA
Nov 2026
Regeneron indicated that the FDA will review the 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 EC is anticipated in the second half of 2027.Source filing
cemdisiran — Regulatory decision
H2 2027
Regeneron indicated that the FDA will review the 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 EC is anticipated in the second half of 2027.Source filing
nucresiran — Topline data
2028
Topline results are expected in 2028.Source filing
nucresiran — Topline data
by 2030
Given the current pace of enrollment and the anticipated accrual of endpoint events, we continue to expect to launch nucresiran in ATTR-CM by 2030, assuming positive data and regulatory approval.Source filing