GSK Secures $300M Upfront, $390M Milestone Deal for Linerixibat; Supplies Niraparib to J&J
GSK out-licensed global rights for PBC therapy linerixibat to Alfasigma for $300M upfront plus $390M in milestone payments and double-digit royalties, with an FDA decision due March 24, 2026. GSK also supplies niraparib for J&J’s EU-approved Akeega in BRCA1/2-mutated metastatic hormone-sensitive prostate cancer.
1. License Agreement with Alfasigma
GSK signed an exclusive global development and marketing license agreement with Italy-based Alfasigma granting rights to linerixibat for cholestatic pruritus in primary biliary cholangitis. The deal delivers $300 million upfront, potential milestone payments totaling $390 million and tiered double-digit royalties on future net sales.
2. Regulatory and Clinical Status of Linerixibat
Linerixibat, an oral IBAT inhibitor, achieved primary and key secondary endpoints in the late-stage GLISTEN study, showing significant, sustained itch relief in PBC patients. Regulatory filings have been submitted across the US, EU, UK, China and Canada, with an FDA decision expected by March 24, 2026.
3. Partnership for Niraparib
Under an existing collaboration, GSK supplies the PARP inhibitor niraparib to Johnson & Johnson for combination use in Akeega. The therapy recently received EU approval for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, extending its prior indication in metastatic castration-resistant patients.