GSK (GSK) secures FDA approval for Lynavoy to treat PBC cholestatic pruritus

Rhea-AI Filing Summary

GSK plc reports that the US FDA has approved Lynavoy (linerixibat) to treat cholestatic pruritus in adult patients with primary biliary cholangitis (PBC). Lynavoy is an ileal bile acid transporter (IBAT) inhibitor and is the first medicine approved in the US specifically for this indication.

The approval is supported by the phase III GLISTEN trial, which met its primary and key secondary endpoints, showing significant, rapid (by week two) and sustained (over 24 weeks) reductions in itch and itch-related sleep interference versus placebo. The most common side effects were diarrhoea and abdominal pain, generally mild to moderate.

GSK previously signed a licence agreement for Alfasigma S.p.A. to acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat, with this transaction still subject to customary regulatory clearances. Regulatory reviews for linerixibat are also underway in the EU, UK, Canada and China, and the drug has Orphan Drug Designation in the US and Japan and priority review in China.

Positive

• First approved US therapy for PBC-related cholestatic pruritus: Lynavoy (linerixibat) has received FDA approval as the first medicine in the US specifically indicated for cholestatic pruritus in primary biliary cholangitis, addressing a serious, previously poorly treated symptom with high prevalence among PBC patients.
• Robust phase III efficacy data with sustained benefit: The GLISTEN trial met primary and key secondary endpoints, showing significant, rapid (week two) and sustained (24-week) reductions in itch and itch-related sleep interference versus placebo, supporting meaningful clinical benefit.
• Strategic out-licensing agreement in place: GSK has entered a licence agreement granting Alfasigma S.p.A. worldwide exclusive rights to develop, manufacture and commercialise linerixibat, potentially enabling focused commercial execution while GSK continues to build its hepatology pipeline.

Negative

• None.

Insights

Biopharma regulatory and pipeline analyst

FDA approval of Lynavoy validates GSK’s liver pipeline and expands its rare disease portfolio.

The FDA has approved Lynavoy (linerixibat) as the first US treatment specifically for cholestatic pruritus in primary biliary cholangitis. This moves the asset from development into the commercial phase and confirms the clinical relevance of IBAT inhibition in this indication.

The phase III GLISTEN trial met primary and key secondary endpoints, with statistically significant improvements in itch and sleep interference over 24 weeks versus placebo. Safety was consistent with the mechanism, with diarrhoea and abdominal pain the most frequent adverse events, mostly mild to moderate, and relatively low discontinuation rates.

GSK has already agreed to license worldwide exclusive rights for linerixibat to Alfasigma S.p.A., with the transaction subject to customary regulatory clearances such as under the Hart-Scott-Rodino Act. Future disclosures on regulatory decisions in the EU, UK, Canada and China will further shape the global opportunity for this first-in-indication therapy.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2026

Commission File Number 001-15170

GSK plc

(Translation of registrant's name into English)

79 New Oxford Street, London, WC1A 1DG

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F . . . .X. . . . Form 40-F . . . . . . . .

Issued: 19 March 2026, London UK

Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)

●    Lynavoy, an ileal bile acid transporter (IBAT) inhibitor, is the first medicine approved in the US for the treatment of cholestatic pruritus in patients with PBC

●    Up to 89% of people living with PBC experience cholestatic pruritus, an internal itch with a debilitating impact on quality of life1-4

●    Approval based on the positive GLISTEN phase III trial with regulatory reviews underway in the EU, UK, Canada and China

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication.5

GSK previously announced on 9 March a licence agreement under which Alfasigma S.p.A. will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat. This transaction is ongoing and is subject to customary conditions, including applicable regulatory agency clearances such as under the Hart-Scott-Rodino Act in the US.

Cholestatic pruritus is an internal itch experienced by up to 89% of people living with PBC, a rare autoimmune disease that can lead to liver failure.1-4 It is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure.3,6,7

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation, and Head of GSK Translational & Development Sciences, GSK, said: "The approval of Lynavoy in the US gives patients a much needed treatment option that offers rapid, significant and sustained improvement in the debilitating effects of itch caused by PBC. For many patients, cholestatic pruritus remains a persistent, poorly addressed condition. This is the first liver medicine from our pipeline to receive approval, underscoring our commitment to developing meaningful innovation across the spectrum of liver disease."

Christopher Bowlus M.D., Lena Valente Professor and Chief of Gastroenterology and Hepatology, University of California Davis, said: "The approval of linerixibat represents an important opportunity to improve the lives of people with PBC and who struggle with uncontrolled and often debilitating pruritus. The impact of itch on people living with PBC can be profound and treatment options have until now been limited. The FDA's decision marks a major milestone in PBC pruritus care that addresses a critical area of unmet need."

Carol Roberts, President, The PBCers Organization, said: "Cholestatic pruritus has been underestimated and overlooked for far too long, despite its significant impact on people living with PBC. Seeing a treatment specifically developed for chronic itch finally reach patients is a significant step forward and offers hope for those in need."

The approval is based on data from the global GLISTEN phase III trial which met both primary and key secondary endpoints, demonstrating significant, rapid (at week two) and sustained (over 24 weeks) improvements in cholestatic pruritus and itch-related sleep interference versus placebo.8

Linerixibat has been granted Orphan Drug Designation in the US, EU and Japan, and priority review in China, for the treatment of cholestatic pruritus in patients with PBC. Marketing applications for linerixibat are ongoing in the EU, UK, Canada and China.

About cholestatic pruritus in PBC

In PBC, a rare cholestatic liver disease, bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching. Pruritus can occur at any stage of PBC disease or biochemical control.9 It is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure.3,6,7

About Lynavoy (linerixibat)

Linerixibat is an IBAT inhibitor, a targeted oral agent to treat cholestatic pruritus (itch) associated with the rare autoimmune liver disease PBC.8 By inhibiting bile acid re-uptake, linerixibat reduces multiple mediators of pruritus in circulation.5

About the GLISTEN trial

GLISTEN is a double-blind, randomised, placebo-controlled, phase III trial. The primary and key secondary endpoints of the study were met, demonstrating significant, rapid (at week two), and sustained (over 24 weeks) improvements in cholestatic pruritus (p<=0.001) and itch-related sleep interference (p=0.024) versus placebo. The primary endpoint of change from baseline in monthly itch score showed linerixibat (n=119) significantly improved itch versus placebo (n=119) over 24-weeks, as measured on a 0-10 numerical rating scale (NRS) for the worst itch (WI-NRS) (least squares [LS] mean difference [95% CI]: -0.72 [-1.15, -0.28], p=0.001). The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition. The most frequently reported adverse events were diarrhoea (61%) and abdominal pain (18%), both of which were mostly mild to moderate. Treatment discontinuation due to diarrhoea was in 4% of patients versus <1% in placebo, and abdominal pain in 4% versus none in placebo.8

About GSK research in hepatology

GSK is extending its expertise in inflammation to develop a next wave of innovation for the millions of people affected by chronic and life-threatening fibro-inflammatory liver conditions. Harnessing the science of the immune system and advanced technologies, GSK is committed to advancing its hepatology pipeline with potential therapies for chronic hepatitis B and steatotic liver disease (SLD), including metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease (ALD).

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025.

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References

1.     Hegade VS, et al. Clin Gastroenterol Hepatol. 2019;17(7):1379-87. doi: 10.1016/j.cgh.2018.12.00

2.     Mayo MJ, et al. Dig Dis Sci. 2023;68:995-1005. doi: 10.1007/s10620-022-07581-x

3.     de Veer RC, et al. Hepatol Res. 2023;53:401-8. doi: 10.1111/hepr.13880

4.     Gungabissoon U, et al. BMJ Open Gastroenterol. 2024;11;e001287. doi: 10.1136/bmjgast-2023-001287

5.     Kremer A, et al. Hepatol. 2025; 82(S1); S204. doi: 10.1097/HEP.0000000000001493

6.     Smith HT, et al. Hepatol Commun. 2025; 9(3):e0635. doi: 10.1097/HC9.0000000000000635

7.     Lindor KD, et al. Hepatol. 2019;69(1):394-419. doi: 10.1002/hep.30145

8.     Hirschfield GM, et al. Lancet Gastroenterol Hepatol. 2026; 11(1): 22-33. doi: 10.1016/S2468-1253(25)00192-X

9.     Düll MM, Kremer AE. Clin Liver Dis. 2022; 26(4):727-45. doi: 10.1016/j.cld.2022.06.009

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.

GSK plc

(Registrant)

Date: March 19, 2026

By:/s/ VICTORIA WHYTE

--------------------------

Victoria Whyte

Authorised Signatory for and on

behalf of GSK plc

FAQ

What did GSK (GSK) announce about Lynavoy (linerixibat) in this 6-K?

GSK announced that the US FDA approved Lynavoy (linerixibat) for cholestatic pruritus in adult primary biliary cholangitis patients. Lynavoy is an ileal bile acid transporter inhibitor and is the first US-approved medicine specifically for this indication, based on the positive phase III GLISTEN trial.

How effective was Lynavoy in the GLISTEN phase III trial reported by GSK (GSK)?

Lynavoy met the primary and key secondary endpoints in the GLISTEN phase III trial, showing significant, rapid (by week two) and sustained (over 24 weeks) improvements in cholestatic pruritus and itch-related sleep interference versus placebo. Efficacy was measured using a 0–10 numerical rating scale for worst itch.

What side effects of Lynavoy did GSK (GSK) highlight in its 6-K?

GSK reported that Lynavoy’s safety profile was consistent with IBAT inhibition. The most frequent adverse events were diarrhoea in 61% of patients and abdominal pain in 18%, generally mild to moderate. Treatment discontinuation due to diarrhoea occurred in 4% of patients and abdominal pain in 4%.

Does GSK (GSK) have a partner for developing and commercialising linerixibat?

GSK previously agreed that Alfasigma S.p.A. will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat. The transaction remains ongoing and is subject to customary conditions, including regulatory clearances such as under the Hart-Scott-Rodino Act in the United States.

What regulatory designations has Lynavoy (linerixibat) received according to GSK (GSK)?

GSK stated that linerixibat has Orphan Drug Designation in the US and Japan for cholestatic pruritus in PBC, and priority review in China. Marketing applications are also under review in the European Union, United Kingdom, Canada and China, expanding its potential global reach.

How common is cholestatic pruritus in PBC patients, as cited by GSK (GSK)?

GSK cited research indicating that up to 89% of people living with primary biliary cholangitis experience cholestatic pruritus. This internal itch can be debilitating, contributing to sleep disturbance, fatigue, impaired quality of life, and in some cases liver transplantation even without liver failure.