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EMA Accepts GSK's Filing for Linerixibat in Rare Disease-Related Itch
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Key Takeaways
GSK's MAA for linerixibat in cholestatic pruritus tied to PBC has been accepted by the EMA.
Linerixibat showed rapid, significant itch relief in the phase III GLISTEN study versus placebo.
Linerixibat may become the first globally approved therapy for itch associated with PBC.
GSK plc (GSK - Free Report) announced that the European Medicines Agency has accepted its marketing authorization application (MAA) seeking approval of its investigational ileal bile acid transporter (“IBAT”) inhibitor, linerixibat, for treating cholestatic pruritus in patients with primary biliary cholangitis (“PBC”).
Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure.
A regulatory filing seeking approval for linerixibat for the given indication is currently under review in the United States. A final decision from the FDA is expected on March 24, 2026.
Year to date, shares of GSK have increased 13.1% against the industry’s decline of 3.3%.
Image Source: Zacks Investment Research
GSK's MAA for Linerixibat Based on GLISTEN Study
The MAA for linerixibat was based on positive data from the phase III GLISTEN study.
The study met both the primary and key secondary endpoints, wherein treatment with linerixibat led to a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference as compared to placebo.
Management believes that linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally, a condition for which only a few effective treatments are available presently.
Growing Competition in the PBC Market
Some other companies are also developing treatments for PBC, as there remains a high unmet medical need.
Last August, the FDA granted accelerated approval to Gilead Sciences’ (GILD - Free Report) seladelpar for the treatment of PBC, in combination with ursodeoxycholic acid (“UDCA”), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
GILD markets seladelpar under the trade name Livdelzi in the United States.
Earlier this year, the European Commission granted conditional marketing authorization to GILD’s seladelpar for the given indication.
Mirum Pharmaceuticals (MIRM - Free Report) is developing its pipeline candidate, volixibat, an oral IBAT inhibitor, for the treatment of PBC.
The phase IIb VANTAGE study is currently evaluating MIRM’s volixibat for treating PBC.
Mirum expects to complete enrollment in the VANTAGE study in 2026.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have rallied 30.2%.
EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.
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EMA Accepts GSK's Filing for Linerixibat in Rare Disease-Related Itch
Key Takeaways
GSK plc (GSK - Free Report) announced that the European Medicines Agency has accepted its marketing authorization application (MAA) seeking approval of its investigational ileal bile acid transporter (“IBAT”) inhibitor, linerixibat, for treating cholestatic pruritus in patients with primary biliary cholangitis (“PBC”).
Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure.
A regulatory filing seeking approval for linerixibat for the given indication is currently under review in the United States. A final decision from the FDA is expected on March 24, 2026.
Year to date, shares of GSK have increased 13.1% against the industry’s decline of 3.3%.
Image Source: Zacks Investment Research
GSK's MAA for Linerixibat Based on GLISTEN Study
The MAA for linerixibat was based on positive data from the phase III GLISTEN study.
The study met both the primary and key secondary endpoints, wherein treatment with linerixibat led to a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference as compared to placebo.
Management believes that linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally, a condition for which only a few effective treatments are available presently.
Growing Competition in the PBC Market
Some other companies are also developing treatments for PBC, as there remains a high unmet medical need.
Last August, the FDA granted accelerated approval to Gilead Sciences’ (GILD - Free Report) seladelpar for the treatment of PBC, in combination with ursodeoxycholic acid (“UDCA”), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
GILD markets seladelpar under the trade name Livdelzi in the United States.
Earlier this year, the European Commission granted conditional marketing authorization to GILD’s seladelpar for the given indication.
Mirum Pharmaceuticals (MIRM - Free Report) is developing its pipeline candidate, volixibat, an oral IBAT inhibitor, for the treatment of PBC.
The phase IIb VANTAGE study is currently evaluating MIRM’s volixibat for treating PBC.
Mirum expects to complete enrollment in the VANTAGE study in 2026.
GSK's Zacks Rank & Stock to Consider
GSK currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Exelixis (EXEL - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have rallied 30.2%.
EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.