FDA Accepts GSK's NDA for Linerixibat in Rare Disease-Related Itch

GSK plc GSK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval of its investigational targeted inhibitor of the ileal bile acid transporter (“IBAT”), linerixibat, for treating cholestatic pruritus in patients with primary biliary cholangitis (“PBC”).

With the FDA accepting the NDA for review, a decision from the regulatory body is expected on March 24, 2026.

If approved, linerixibat could address an area of high unmet medical need for patients living with cholestatic pruritus and related sleep interference.

Year to date, shares of GSK have rallied 23.2% against the industry’s decline of 3.8%.

Linerixibat NDA Based on GSK's GLISTEN Study

The NDA for linerixibat was based on data from the phase III GLISTEN study. In November 2024, the company announced positive data from the 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 versus placebo.

Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure.

Per management, if successfully developed, linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally.

Other Players in the PBC Market

A few other companies are also developing treatments for PBC, as there remains a high unmet medical need.

In August 2024, the FDA granted accelerated approval to Gilead Sciences’ GILD 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.

The candidate was approved under the brand name Livdelzi.

Seladelpar was added to GILD’s portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024. The approval of Livdelzi strengthened GILD’s liver disease portfolio.

Small biotech Mirum Pharmaceuticals MIRM is developing its pipeline candidate, volixibat, also 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 & Another Key Pick

GSK currently carries a Zacks Rank #2 (Buy).

Another top-ranked stock in the biotech sector is Immunocore Holdings IMCR, carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s loss per share have narrowed from $1.57 to 86 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.80 to $1.34. Year to date, shares of IMCR have rallied 31.1%.

IMCR’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 76.18%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research