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 bepirovirsen: GSK continues regulatory submissions for bepirovirsen across multiple geographies with key decisions anticipated in the coming months. (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: bepirovirsen — GSK continues regulatory submissions for bepirovirsen across multiple geographies with key decisions anticipated in the coming months. (H2 2026). 2 catalysts 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 21, 2026met B-WELL phase III trials demonstrated 19% functional cure rate with bepirovirsen versus 0% with placebo in adults with ≤3000 IU/ml HBsAg.
Pooled data from the B-Well phase III trials showed that six-month treatment with bepirovirsen achieved a clinically meaningful 19% functional cure response rate (233 of 1,220 vs. 0 of 614 in the placebo group).
Filing - Oct 20, 2026approval FDA approved Hibsago (bepirovirsen) for chronic hepatitis B in adults without cirrhosis on nucleos(t)ide analogue therapy with HBsAg <=3000 IU/ml; B-Well functional cure 19% vs 0%.
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy.
Filing - Oct 19, 2026approval FDA granted accelerated approval to Jemperli as the first immunotherapy for MSI-H/dMMR locally advanced rectal cancer, ahead of the PDUFA date.
The US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) as the first and only immunotherapy for adults with stage II and III microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer under the accelerated approval pathway.
Filing
32 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
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- Novavax Inc NVAX
- Sinovac Biotech Ltd SVA
- CorMedix Inc. CRMD
- Valneva SE VALN
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.