Shots:
- GSK has granted Alfasigma worldwide exclusive rights to develop, manufacture & commercialise linerixibat for cholestatic pruritus in primary biliary cholangitis
- As per the deal, GSK will receive $300M upfront, $100M upon FDA approval (based on PDUFA date of Mar 24, 2026), $20M upon EU & UK approval, & ~$270M in sales milestones, along with tiered double-digit royalties on global sales
- Linerixibat is under regulatory review in the US, EU, UK, China (priority review) & Canada, based on the P-III (GLISTEN) trial, which met its 1 & 2EPs, showing rapid & sustained improvement in cholestatic pruritus along with reduced itch-related sleep interference
Ref: GSK | Image: GSK & Alfasigma | Press Release
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