pelabresib — NDA/BLA submission
2026
In January 2026, Novartis announced plans to submit a European Union regulatory filing for pelabresib in 2026, and that it would begin a new Phase 3 study in the United States, China and Japan.Source filing
RPRX biotech catalysts & pipeline
ROYALTY PHARMA PLC · Data as of 2026-09-08
Upcoming catalysts
sacituzumab govitecan — NDA/BLA submission
2026
In October 2025, Gilead announced that based on the positive Phase 3 updates from ASCENT-03 and ASCENT-04, it has submitted two supplemental BLAs for Trodelvy in 1L metastatic triple-negative breast cancer and expects regulatory decisions in 2026.Source filing
olanzapine LAI — PDUFA
H2 2026
FDA approval expected H2 2026Source filing
Pelacarsen — Topline data
H2 2026
Phase 3 data expected H2 2026Source filing
Cobenfy — Topline data
Late 2026
Following consultation with the FDA and a review by the independent Data Monitoring Committee, the study will continue as planned with results expected by the end of 2026.Source filing
Jideytro (zidesamtinib) — PDUFA
Sep 18
PDUFA date September 18, 2026Source filing
Litifilimab — Topline data
Q4 2026
Phase 3 data expected Q4 2026Source filing
neladalkib — PDUFA
Nov 27
In May 2026, Nuvalent announced the FDA accepted its NDA for neladalkib for filing and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of November 27, 2026.Source filing
Frexalimab — Topline data
2027
Phase 3 data expected 2027Source filing
Olpasiran — Topline data
2027
Phase 3 data expected 2027Source filing
Omecamtiv mecarbil — Topline data
2027
Phase 3 data expected 2027Source filing
Seltorexant — Topline data
2027
Phase 3 data expected 2027Source filing
deucrictibant immediate-release — PDUFA
Apr 23
In July 2026, Pharvaris announced that the FDA accepted its NDA for deucrictibant immediate-release for the on-demand treatment of hereditary angioedema attacks and assigned a PDUFA date of April 23, 2027.Source filing
Trontinemab — Topline data
2028
Phase 3 data expected 2028Source filing