GSK plc GSK
GSK plc (NYSE: GSK) is an infectious disease drug developer. Its lead program, Hibsago (bepirovirsen), is in Phase 3 for chronic hepatitis B virus infection. Its next catalyst on record is HS235 (35Pharma): Start PAH and PH-HFpEF studies (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: HS235 (35Pharma) — Start PAH and PH-HFpEF studies (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Hibsago (bepirovirsen) | chronic hepatitis B | RNA (siRNA/ASO/mRNA) | Approved |
| Exdensur (depemokimab) | asthma; CRSwNP | antibody | Approved |
| Nucala (mepolizumab) | COPD, asthma and others | antibody | Approved |
| Blenrep (belantamab mafodotin) | 2L+ multiple myeloma | antibody | Approved |
| Blujepa (gepotidacin) | uncomplicated UTI; gonorrhoea | small molecule | Approved |
| Arexvy (RSV vaccine) | RSV prophylaxis | vaccine | Approved |
| linerixibat | cholestatic pruritus in PBC | small molecule | Phase 3 |
| tebipenem pivoxil | complicated UTI | small molecule | Phase 3 |
| camlipixant | refractory chronic cough | small molecule | Phase 3 |
| efimosfermin alfa | MASH | protein/peptide | Phase 3 |
| risvutatug rezetecan | extensive-stage SCLC | antibody | Phase 3 |
| velzatinib | GIST | small molecule | Phase 3 |
Recent results and decisions
- Oct 28, 2026approval Hibsago approved in US and Japan for chronic hepatitis B.
Hibsago approved in US and Japan, with data showing unprecedented functional cure rates and potential to redefine treatment of chronic hepatitis B
Filing - Oct 28, 2026positive Positive registrational data for Jideytro in first-line ROS1-positive non-small cell lung cancer.
Positive registrational data for Jideytro in first-line ROS1-positive non-small cell lung cancer (approved in US in second-line in July)
Filing - Oct 28, 2026started ZENITH-1 phase III trial for efimosfermin alfa in F2-F3 MASH started in Q4 2025.
A phase III, randomised, double-blind, placebo-controlled, 3-arm study to investigate the safety and efficacy of efimosfermin alfa in participants with biopsy-confirmed F2- or F3-stage metabolic dysfunction-associated steatohepatitis (MASH)
Filing
48 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 infectious disease companies
- Vaxcyte, Inc. PCVX
- Sinovac Biotech Ltd SVA
- Valneva SE VALN
- Kamada Ltd KMDA
- CorMedix Inc. CRMD
- Atea Pharmaceuticals, Inc. AVIR
- SIGA Technologies, Inc. SIGA
- Invivyd, Inc. IVVD
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.