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 February 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: 26 February 2026, London UK
Linerixibat accepted for priority review in China for cholestatic
pruritus in patients with primary biliary cholangitis
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Submission
based on data from positive GLISTEN phase III
trial
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Linerixibat
demonstrated significant and sustained improvement in cholestatic
pruritus versus placebo
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Regulatory
reviews underway in US, EU, UK and Canada
GSK plc (LSE/NYSE: GSK) today announced that its new drug
application for the use of linerixibat for the treatment of
cholestatic pruritus in patients with primary biliary cholangitis
(PBC), a rare autoimmune liver disease, has been accepted for
priority review by China's National Medical Products
Administration. Linerixibat is an investigational inhibitor of the
ileal bile acid transporter (IBAT), developed to reduce mediators
of cholestatic pruritus - an internal and relentless
itch.
The application is based on positive data from the GLISTEN phase
III trial, presented last year at the European Association for the
Study of the Liver (EASL) Congress.1 GLISTEN
met both primary and key secondary endpoints demonstrating a rapid,
significant and sustained improvement in cholestatic pruritus and
itch-related sleep interference versus placebo. The safety profile
of linerixibat was consistent with previous studies and the
mechanism of IBAT inhibition.2
Cholestatic pruritus in PBC is a serious and debilitating
condition, with patients experiencing sleep disturbance and
impaired quality of life and sometimes requiring liver transplant
in the absence of liver failure.3,4,5
In China, approximately 280,000 people are affected by PBC, and
cholestatic pruritus, for which there are few effective treatment
options, is estimated to impact up to 89% of PBC patients during
the course of their disease.3,
6-9
Linerixibat has also been granted Orphan Drug Designation in the
US, EU and Japan for the treatment of cholestatic pruritus in
patients with PBC. Marketing applications for linerixibat are
currently under Health Authority review in the US, EU, UK and
Canada. Linerixibat is currently not approved anywhere in the
world.
About linerixibat
Linerixibat is an IBAT inhibitor, a targeted oral agent to treat
cholestatic pruritus associated with the rare autoimmune liver
disease PBC.2 By
inhibiting bile acid re-uptake, linerixibat reduces multiple
mediators of pruritus in circulation.10
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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GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Sarah Clements
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Constantin Fest
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+44 (0) 7831 826525
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Sam Piper
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+44 (0) 7824 525779
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 3126
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(Philadelphia)
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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 2024, and
GSK's Q4 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. Hirschfield
GM, et al. J
Hepatol. 2025; 82(S1);
S4-5. doi:
10.1016/S0168-8278(25)00303-4
2. Hirschfield
GM, et al. Lancet
Gastroenterol Hepatol. 2026; 11(1): 22-33. doi:
10.1016/S2468-1253(25)00192-X
3. Mayo
MJ, et al. Dig Dis
Sci. 2023;68:995-1005. doi:
10.1007/s10620-022-07581-x
4.
Smith HT, et al. Hepatol Commun. 2025; 9(3):e0635. doi:
10.1097/HC9.0000000000000635
5. Lindor KD, et
al. Hepatol. 2019;69(1):394-419. doi:
10.1002/hep.30145
6. Zeng N, et
al. Hepatol
Int. 2019;13(6):788-99.
doi: 10.1007/s12072-019-09984-x
7. Hegade VS, et
al. Clin Gastroenterol
Hepatol. 2019;17(7):1379-87. doi:
10.1016/j.cgh.2018.12.00
8. de Veer RC, et
al. Hepatol
Res. 2023;53:401-8. doi:
10.1111/hepr.13880
9. Gungabissoon U, et
al. BMJ Open
Gastroenterol. 2024;11;e001287. doi:
10.1136/bmjgast-2023-001287
10. Kremer A, et
al. Hepatol. 2025; 82(S1); S204. doi:
10.1097/HEP.0000000000001493
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.
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GSK plc
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(Registrant)
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Date: February
26, 2026
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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