FDA grants bepirovirsen priority review and Breakthrough status; PDUFA 26 Oct 2026
The FDA approved GSK’s Bepirovirsen for Chronic hepatitis B on Apr 28, 2026. That clears it for sale in the US.
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- Company
- GSK plc GSK
- Drug
- Bepirovirsen
- For
- Chronic hepatitis B
- Stage
- Phase 1/2 · an early study that checks safety and takes a first look at effect
- When
- Apr 28, 2026
- Source note
- GSK announced FDA acceptance under priority review of the bepirovirsen NDA for chronic hepatitis B, plus Breakthrough Therapy Designation, with a 26 October 2026 PDUFA date.
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- GSK headlines on this site
Camlipixant US regulatory submission planned for H2 2026, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Camlipixant (P2X3 antagonist) for Refractory chronic cough): a step in the program rather than a decision or a data readout.
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- Entry
- Camlipixant US regulatory submission planned for H2 2026 · Company milestone
- Drug
- Camlipixant (P2X3 antagonist)
- For
- Refractory chronic cough
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- GSK guidance (company reporting reflected in 2026 SEC filings) plans US, EU, and Japan regulatory submissions for camlipixant in H2 2026, setting up a likely 2027 FDA decision.
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- ClinicalTrials.gov ↗ — trials of this drug
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GSK expects to report results from its Phase III (OCEAN) study of Exdensur (depemokimab) for Eosinophilic granulomatosis with polyangiitis in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.
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- Entry
- Exdensur (depemokimab) Phase III OCEAN readout in EGPA · Clinical trial results (readout / topline data)
- Drug
- Exdensur (depemokimab)
- For
- Eosinophilic granulomatosis with polyangiitis
- Stage
- Phase III (OCEAN)
- When
- H2 2026 · the company gave a window, not a day
- Source note
- GSK Q2 2026 results 'Anticipated pipeline milestones' table (Jul 28, 2026); EGPA submissions (US, EU, CN, JP) guided for H1 2027 and US/JP decisions H2 2027.
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Jemperli AZUR-1 US regulatory submission in dMMR locally advanced rectal cancer, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Jemperli (dostarlimab) for dMMR locally advanced rectal cancer): a step in the program rather than a decision or a data readout.
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- Entry
- Jemperli AZUR-1 US regulatory submission in dMMR locally advanced rectal cancer · Company milestone
- Drug
- Jemperli (dostarlimab)
- For
- dMMR locally advanced rectal cancer
- Stage
- Phase 1 · an early safety study in a small group of people
- When
- H2 2026 · the company gave a window, not a day
- Source note
- GSK Q2 2026 milestones table; positive AZUR-1 pivotal data reported in Q2 2026. JP submission H1 2027; EU/CN submission H2 2027.
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The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve GSK’s Jemperli (dostarlimab) for dMMR locally advanced rectal cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- FDA decision on Jemperli for dMMR rectal cancer (AZUR-1) · FDA decision due (PDUFA date)
- Drug
- Jemperli (dostarlimab)
- For
- dMMR locally advanced rectal cancer
- Stage
- Under FDA review (expected)
- When
- H2 2026 · the company gave a window, not a day
- Source note
- GSK guides to both US submission and US regulatory decision within H2 2026 (implies expedited review). EU decision guided H2 2027.
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- GSK headlines on this site
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GSK expects to report results from its Phase IIb registrational (EXTEND4M) study of Cabotegravir ultra-long-acting (ViiV) for HIV pre-exposure prophylaxis in the second half of 2026 (no exact date yet). Phase IIb registrational (EXTEND4M) is a study designed to support approval.
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- Entry
- Cabotegravir 3x-yearly PrEP Phase IIb EXTEND4M registrational data · Clinical trial results (readout / topline data)
- Drug
- Cabotegravir ultra-long-acting (ViiV)
- For
- HIV pre-exposure prophylaxis
- Stage
- Phase IIb registrational (EXTEND4M) · a study designed to support approval
- When
- H2 2026 · the company gave a window, not a day
- Source note
- GSK Q2 2026; milestones table also lists a US regulatory submission in H2 2026 and US regulatory decision in H1 2027 for 3x-a-year cabotegravir PrEP.
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The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve GSK’s Arexvy (RSVPreF3 OA) for RSV prevention, immunocompromised adults aged 18+. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- FDA decision on Arexvy for immunocompromised adults 18+ · FDA decision due (PDUFA date)
- Drug
- Arexvy (RSVPreF3 OA)
- For
- RSV prevention, immunocompromised adults aged 18+
- Stage
- sBLA under FDA review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- GSK Q2 2026 results; already approved for IC adults in the EEA. China decision for adults 60+ expected in 2027.
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- ClinicalTrials.gov ↗ — trials of this drug
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- GSK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page