Exdensur (depemokimab) — Topline data
in 2026
Further pivotal readouts expected in 2026: camlipixant (chronic cough); Jemperli (rectal cancer); 3x yearly (Q4M) HIV PrEP; and Exdensur for EGPASource filing
GSK biotech catalysts & pipeline
GSK PLC · Data as of 2026-09-08
Upcoming catalysts
neladalkib — PDUFA
2026
Zidesamtinib (NVL-520) and neladalkib (NVL-655) are considered potential best-in-class assets, based on clinical data, and are under FDA review for ROS1-positive and ALK-altered non-small cell lung cancer (NSCLC) with target decision dates later this year.Source filing
neladalkib — PDUFA
H2 2026
Two late-stage medicines for non-small cell lung cancer acquired: Jideytro (FDA approval) & neladalkib (PDUFA H2 2026)Source filing
Jideytro (zidesamtinib) — PDUFA
Sep 18
The approval comes ahead of the original target action date of 18 September 2026 and follows the FDA's Breakthrough Therapy and Orphan Drug Designations.Source filing
Hibsago (bepirovirsen) — PDUFA
Oct 26
The FDA has assigned 26 October 2026 as the Prescription Drug User Fee Act (PDUFA) goal date.Source filing
neladalkib — PDUFA
Nov 27
The company is advancing additional medicines from the recent Nuvalent acquisition, including neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review with a target decision date of 27 November 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC.Source filing
Arexvy — Regulatory decision
2027
A regulatory decision is expected in 2027.Source filing
ozureprubart — Topline data
2027
Data from the phase IIb trial (prestIgE) assessing use of ozureprubart as monotherapy is expected in 2027, with phase III trials to be focused on both at-risk adult and paediatric populations.Source filing
risvutatug rezetecan — Topline data
next year
GSK's broad clinical development programme includes studies in lung cancer, prostate cancer and other solid tumours, including the global phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer (ES-SCLC) with pivotal data expected next year.Source filing
Jemperli (dostarlimab) — PDUFA
Feb 2027
The FDA has assigned a PDUFA action date of February 2027.Source filing
Blenrep (belantamab mafodotin) — Topline data
early 2028
Follow-up continues for overall survival (OS) in both DREAMM-7 and DREAMM-8 with data expected in early 2028, including in patients who have received only one prior line of therapy.Source filing
Jemperli (dostarlimab) — Conference presentation
2026
These data will be submitted for presentation at a scientific congress later in 2026.Source filing
Bexsero — Conference presentation
Sep 13–Sep 17
Full data will be presented at the 25th International Pathogenic Neisseria Conference (IPNC) in September.Source filing