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: 27th March
2026, London UK
Bepirovirsen accepted
for review by the European Medicines Agency as
a potential first-in-class treatment for chronic hepatitis
B
● Submission
supported by statistically significant and clinically meaningful
functional cure rates in pivotal PhIII B-Well
trials.
● Nearly
3.2 million
people in Europe live
with chronic hepatitis B (CHB), a leading cause of liver
cancer.[1]
GSK plc (LSE/NYSE: GSK) today
announced that the European Medicines Agency (EMA) has accepted for
review the marketing authorisation application (MAA) for the use
of bepirovirsen,
an investigational antisense oligonucleotide (ASO), in the
treatment of adults with chronic hepatitis B
(CHB).
Chronic hepatitis B remains a public health concern in Europe, with
an estimated 3.2 million people living with CHB.1The
current standard of care - nucleos(t)ide
analogues - often
requires lifelong therapy and the functional cure rates remain low,
typically only 1%.
[2] Functional
cure occurs when the hepatitis B virus DNA and viral protein -
hepatitis B surface antigen (HBsAg) - are undetectable in the blood
for at least 24 weeks after stopping all treatment, indicative of
the disease being controlled by the immune system without
medication. It
is estimated that ~56% of liver cancer cases globally are caused by
CHB.[3]
The regulatory submission to EMA is based on positive results from
the B-Well 1 and B-Well 2 Phase III trials. Both trials met their
primary endpoint, and bepirovirsen demonstrated a statistically
significant and clinically meaningful functional cure rate.
Functional cure rates were significantly higher with bepirovirsen
plus standard of care compared with standard of care alone. Results
were statistically significant across all ranked endpoints,
including in patients with baseline surface antigen (HBsAg)
<=1000 IU/ml where an even greater effect was demonstrated. The
trials demonstrated an acceptable safety and tolerability profile
consistent with what was reported in other
studies. These
data will be presented at a congress and submitted for scientific
peer-reviewed publication in 2026.
About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and
chronic liver disease. Chronic hepatitis B occurs when the immune
system is unable to clear the virus, resulting in long-lasting
infection that affects more than 250 million people worldwide. The
disease causes approximately 1.1 million deaths each year
globally[4],
including an estimated 15,000 in Europe.1 Many
patients require lifelong antiviral therapy for viral suppression,
making functional cure a critical goal in disease management. The
European Association for the Study of the Liver (EASL) guidelines
identify functional cure as the ultimate goal of
treatment.[5]
About bepirovirsen
Bepirovirsen is a triple action investigational antisense
oligonucleotide (ASO), designed to recognise and orchestrate the
destruction of the genetic components (i.e. mRNA and pregenomic
RNA) of the hepatitis B virus that can lead to chronic disease,
potentially allowing a person's immune system to regain control.
Bepirovirsen inhibits the replication of the viral genome in the
body, suppresses the level of hepatitis B surface antigen (HBsAg)
in the blood, and stimulates the immune system to increase the
chances of a durable and sustained response.
About B-Well Clinical trial programmes
B-Well
1 and B-Well 2 trials are global multi-centre, randomised,
double-blind, placebo-controlled trials conducted in 29 countries.
They assessed the efficacy, safety, pharmacokinetic profile, and
the durability of functional cure in nucleos(t)ide analogue
(NA)-treated participants with CHB and baseline surface antigen
(HBsAg) ≤3000 IU/ml. The primary endpoint assessed the
proportion of participants achieving functional cure in patients
with baseline surface antigen (HBsAg) ≤3000 IU/ml. A key
ranked secondary endpoint evaluated functional cure in participants
with baseline HBsAg ≤1000 IU/ml. Functional cure is defined
as hepatitis B surface antigen (HBsAg) loss and undetectable HBV
DNA for at least 24 weeks after a finite course of
treatment.
Bepirovirsen is also being evaluated as a potential backbone
therapy for future sequential treatment strategies aimed at
expanding functional cure to broader patient
populations.
GSK licensed bepirovirsen from Ionis Pharmaceuticals and
collaborated with them on its development. Bepirovirsen is
currently not approved anywhere in the world.
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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Investor
Relations:
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Fest
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(London)
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Jeff
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Frannie
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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
[1] European
Centre for Disease Prevention and Control. World Hepatitis Day
2025: Hepatitis burden remains high across the EU/EEA. 28 July
2025. Available at : https://www.ecdc.europa.eu/en/news-events/world-hepatitis-day-2025 (last
accessed February 2026).
[2] Slaets,
L. et al. "Systematic review with meta-analysis: hepatitis B
surface antigen decline and seroclearance in chronic hepatitis B
patients on nucleos(t)ide analogues or pegylated interferon
therapy" in GastroHep 2, 106-116 (2020)
[3] Maucort-Boulch,
D., de Martel, C., Franceschi, S. and Plummer, M. (2018), Fraction
and incidence of liver cancer attributable to hepatitis B and C
viruses worldwide. Int. J. Cancer, 142: 2471-2477. Available
at: https://doi.org/10.1002/ijc.31280 (last
accessed March 2026)
4 WHO Global Hepatitis Report
2024. Available at https://www.who.int/publications/i/item/9789240091672 (last
accessed March 2026)
[5] EASL
Guidelines available at https://easl.eu/publication/easl-guidelines-management-of-hepatitis-b/ (last
accessed March 2026)
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
27, 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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