Tebipenem pivoxil

Q1 2026: GSK published a “Pipeline assets and clinical trials appendix” detailing late-stage programs, recent pipeline changes since Q4 2025, and expected 2026–2027 catalysts across respiratory/immunology, oncology, HIV and infectious diseases.

Key achieved/changed catalysts since Q4 2025:

• Progressed to Phase III/registration: Benlysta (belimumab) for systemic sclerosis–associated ILD; Exdensur (depemokimab) for severe asthma/CRSwNP (regulatory decisions noted in EU/CN); Lynavoy (linerixibat) for cholestatic pruritus in PBC (US).
• Regulatory decisions: Nucala (mepolizumab) COPD (EU); Blenrep (belantamab mafodotin) 2L+ multiple myeloma (CN); Arexvy (RSV) 18–49 at increased risk (US).
• Regulatory submission acceptances: Lynavoy (PBC; CN); Arexvy (older adults 60+; CN); bepirovirsen (chronic HBV; US/EU/CN/JP).
• Late-stage readout: Exdensur NIMBLE (asthma) Phase III readout.
• Business/development: On 22 April 2026, GSK licensed worldwide rights for Lynavoy (linerixibat) to Alfasigma S.p.A.
• Designations noted: efimosfermin alfa (MASH) Breakthrough Therapy (US) and PRIME (EU); bepirovirsen (chronic HBV) Breakthrough Therapy (US); risvutatug rezetecan (ES-SCLC) Orphan Drug (JP).

Upcoming pipeline catalysts (2026–2027) highlighted:

• Regulatory decisions: tebipenem pivoxil (complicated UTI; US, H1 2026); Ventolin low-carbon MDI (asthma; EU, H1 2026); multiple Arexvy and bepirovirsen decisions across regions in 2026; camlipixant (refractory chronic cough) decisions in 2027; Exdensur (EGPA) decision in 2027.
• Late-stage readouts: camlipixant CALM-1/2 (RCC), Exdensur OCEAN (EGPA), Jemperli AZUR-1 (rectal cancer), and cabotegravir studies (CUATRO treatment; EXTEND4M PrEP).