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GSK Out-Licenses Rights for Rare Liver Disease Drug to Alfasigma
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Key Takeaways
GSK grants Alfasigma exclusive global rights to develop and market linerixibat for PBC-related pruritus.
GSK will receive $300M upfront and up to $390M in milestones plus tiered royalties on global sales.
GSK reported positive phase III GLISTEN data; FDA decision on linerixibat expected by March 24, 2026.
GSK plc (GSK - Free Report) signed a license agreement with Italy-based Alfasigma. Per the terms of the agreement, Alfasigma has acquired exclusive global rights from GSK to develop and market linerixibat, an investigational therapy for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC).
PBC is a chronic autoimmune disease in which bile flow from the liver is disrupted, leading to a build-up of bile acids. This excess bile can cause intense itching, called cholestatic pruritus, which cannot be relieved by scratching.
In return for granting these rights, GSK will receive $300 million as an upfront payment from Alfasigma. The company will be eligible to receive milestone payments, including $100 million upon the FDA’s approval of the drug, $20 million upon approvals in the EU and the UK, and up to $270 million in sales-based milestone payments. In addition, GSK will be eligible to receive tiered double-digit royalties on linerixibat’s net sales worldwide.
GSK Stock’s Performance
Year to date, shares of GSK have gained 13% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
More on GSK’s Linerixibat
Linerixibat is an orally-administered drug designed to inhibit the ileal bile acid transporter (IBAT), which reduces multiple mediators of pruritus in circulation. The drug is yet to be approved anywhere in the world.
Last year, GSK reported full results from the late-stage GLISTEN study, which evaluated linerixibat in PBC patients with cholestatic pruritus. The study achieved its primary and key secondary endpoints — treatment with the drug led to rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference compared with placebo.
Based on the above results, GSK submitted regulatory filings for linerixibat across the United States, the EU, the UK, China and Canada. A final decision from the FDA is expected by March 24, 2026.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.28 to $9.00, while the same for 2027 have risen from $9.25 to $10.10. The stock has declined 5% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, ALX Oncology’s 2026 loss per share estimates have narrowed from $1.21 to 88 cents, while the same for 2027 have declined from 99 cents to 60 cents. ALXO shares have rallied over 88% year to date.
ALX Oncology’s earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 12.82%.
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GSK Out-Licenses Rights for Rare Liver Disease Drug to Alfasigma
Key Takeaways
GSK plc (GSK - Free Report) signed a license agreement with Italy-based Alfasigma. Per the terms of the agreement, Alfasigma has acquired exclusive global rights from GSK to develop and market linerixibat, an investigational therapy for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC).
PBC is a chronic autoimmune disease in which bile flow from the liver is disrupted, leading to a build-up of bile acids. This excess bile can cause intense itching, called cholestatic pruritus, which cannot be relieved by scratching.
In return for granting these rights, GSK will receive $300 million as an upfront payment from Alfasigma. The company will be eligible to receive milestone payments, including $100 million upon the FDA’s approval of the drug, $20 million upon approvals in the EU and the UK, and up to $270 million in sales-based milestone payments. In addition, GSK will be eligible to receive tiered double-digit royalties on linerixibat’s net sales worldwide.
GSK Stock’s Performance
Year to date, shares of GSK have gained 13% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
More on GSK’s Linerixibat
Linerixibat is an orally-administered drug designed to inhibit the ileal bile acid transporter (IBAT), which reduces multiple mediators of pruritus in circulation. The drug is yet to be approved anywhere in the world.
Last year, GSK reported full results from the late-stage GLISTEN study, which evaluated linerixibat in PBC patients with cholestatic pruritus. The study achieved its primary and key secondary endpoints — treatment with the drug led to rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference compared with placebo.
Based on the above results, GSK submitted regulatory filings for linerixibat across the United States, the EU, the UK, China and Canada. A final decision from the FDA is expected by March 24, 2026.
GSK PLC Sponsored ADR Price
GSK PLC Sponsored ADR price | GSK PLC Sponsored ADR Quote
GSK’s Zacks Rank
GSK currently carries a Zacks Rank #3 (Hold).
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals (ANIP - Free Report) and ALX Oncology Holdings (ALXO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.28 to $9.00, while the same for 2027 have risen from $9.25 to $10.10. The stock has declined 5% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, ALX Oncology’s 2026 loss per share estimates have narrowed from $1.21 to 88 cents, while the same for 2027 have declined from 99 cents to 60 cents. ALXO shares have rallied over 88% year to date.
ALX Oncology’s earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 12.82%.