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: 9 March 2026, London UK
GSK and Alfasigma announce agreement on worldwide rights for
linerixibat
GSK plc (LSE/NYSE: GSK) and Alfasigma S.p.A. today announced a
licence agreement under which Alfasigma will acquire worldwide
exclusive rights to develop, manufacture and commercialise
linerixibat, an investigational ileal bile acid transporter (IBAT)
inhibitor being developed for cholestatic pruritus in primary
biliary cholangitis (PBC).
Alfasigma is a global pharmaceutical company with established
capabilities in specialty care and rare diseases. The company has
significant experience in developing and commercialising therapies
for serious liver diseases, including PBC, and has products in more
than 100 markets worldwide.
Tony Wood, Chief Scientific Officer, GSK said:
"We're proud of the role GSK has played discovering and developing
linerixibat to advance treatment in this rare disease with high
unmet need. We believe Alfasigma, given their expertise in PBC, is
the right partner to take this medicine forward for patients. This
agreement sharpens GSK's focus to deliver our next wave of liver
disease innovation, including potential treatments for chronic
hepatitis B, MASH and ALD, which account for two million deaths
annually and have a major impact on healthcare
utilisation."
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 currently under regulatory review in the US,
EU, UK, China and Canada, based on positive data from the GLISTEN
phase III trial. GLISTEN met 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.1
Linerixibat is not currently approved anywhere in the
world.
Francesco Balestrieri, Chief Executive Officer,
Alfasigma, said:
"Alfasigma is committed to advancing rare and specialty care by
developing and delivering innovative solutions that address some of
the most complex healthcare challenges. With our deep hepatology
expertise and strong global footprint, we are uniquely positioned
to lead the worldwide commercialization of linerixibat. This
agreement underscores our strategic focus on bringing meaningful
new treatments to patients and improving outcomes for communities
around the world."
Financial considerations
Under the terms of the agreement, GSK will receive an upfront
payment of $300 million, plus $100 million upon US FDA approval
(expected prior to transaction closing, based on current PDUFA
target approval date of 24 March 2026). Additionally, GSK is
eligible to receive $20 million upon EU and UK approval, and up to
$270 million in sales-based milestone payments. GSK will also earn
tiered double-digit royalties on net sales worldwide.
This transaction is subject to customary conditions, including
applicable regulatory agency clearances such as under the
Hart-Scott-Rodino Act in the US.
About cholestatic pruritus in PBC
In PBC, a 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.2 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.3-5 Data
from the US indicate that itch is frequently undocumented in
medical records and up to one-third of patients experiencing
clinically significant itch do not receive any
treatment.6
About linerixibat (GSK2330672)
Linerixibat is an IBAT inhibitor, a targeted oral agent with
potential to treat cholestatic pruritus (itch) associated with the
rare autoimmune liver disease PBC.1 By
inhibiting bile acid re-uptake, linerixibat reduces multiple
mediators of pruritus in circulation.7
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 Alfasigma
Alfasigma is a global pharmaceutical company headquartered in Italy
with products in over 100 markets across Europe, North and South
America, Asia, and Africa. Alfasigma is dedicated to research,
development, production, and distribution of medicinal products,
contributing to its mission to provide better health and a better
quality of life for patients, caregivers, and healthcare providers.
Its portfolio spans from primary care to specialty care, rare
disease medications, and consumer health products, including
medical food and nutraceuticals. Visit www.alfasigma.com.
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 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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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
2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. Hirschfield
GM, et al. Lancet Gastroenterol
Hepatol. 2026; 11(1):
22-33. doi: 10.1016/S2468-1253(25)00192-X
2. Düll MM, Kremer
AE. Clin Liver
Dis. 2022; 26(4):727-45.
doi: 10.1016/j.cld.2022.06.009
3. Smith H, et
al. Hepatol
Commun. 2025; 9(3):e0635.
doi: 10.1097/HC9.0000000000000635
4. Mayo MJ, et
al. Dig Dis
Sci. 2023;68(3):995-1005.
doi: 10.1007/s10620-022-07581-x
5. Lindor KD, et
al. Hepatol. 2019;69(1):394-419. doi:
10.1002/hep.30145
6. Gungabissoon U, et
al. BMJ Open Gastroenterol.
2024; 11;e001287. doi:
10.1136/bmjgast-2023-001287
7. 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: March
09, 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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