GSK plc (LSE/NYSE: GSK) shares experienced a decline of 1.5% today, despite the announcement of a licensing agreement with Alfasigma S.p.A. for linerixibat, an investigational treatment for cholestatic pruritus in primary biliary cholangitis (PBC).
The agreement grants Alfasigma worldwide exclusive rights to develop, manufacture, and commercialize linerixibat.
Under the terms of the agreement, GSK will receive an upfront payment of $300 million. An additional $100 million is contingent upon US FDA approval, anticipated before the transaction closes, given the current PDUFA target approval date of March 24, 2026.
Further milestones include $20 million upon EU and UK approval, and up to $270 million in sales-based milestone payments. GSK will also earn tiered double-digit royalties on net sales worldwide.
Alfasigma, a global pharmaceutical company with a strong presence in specialty care and rare diseases, is well-positioned to advance linerixibat.
Their established capabilities in developing and commercializing therapies for liver diseases, including PBC, and their extensive global reach in over 100 markets, make them a suitable partner to maximize the drug’s potential.
Tony Wood, Chief Scientific Officer, GSK said: “We’re proud of the role GSK has played discovering and developing linerixibat to advance treatment in this rare disease with high unmet need. We believe Alfasigma, given their expertise in PBC, is the right partner to take this medicine forward for patients. This agreement sharpens GSK’s focus to deliver our next wave of liver disease innovation.”
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