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 April 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: 27 April 2026, London UK
GSK's investigational liver therapy, efimosfermin, receives US FDA
Breakthrough Therapy and EMA Priority Medicines (PRIME)
designations for MASH
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Phase
II data show once-monthly efimosfermin improved liver fibrosis
(scarring), a key driver of disease progression in metabolic
dysfunction-associated steatohepatitis (MASH)
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MASH
is a leading cause of liver transplant in the US and
Europe
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Designations
recognise potential for efimosfermin to address significant unmet
medical need and reflect momentum in GSK's liver health
pipeline
GSK plc (LSE/NYSE: GSK) today announced that efimosfermin, a
once-monthly investigational liver therapy, has been granted
Breakthrough Therapy Designation by the US Food and Drug
Administration (FDA) and Priority Medicines (PRIME) Designation by
the European Medicines Agency (EMA) for the treatment of
MASH.
The FDA designation is designed to expedite the development and
review of medicines for serious conditions, where preliminary
clinical evidence indicates the potential for substantial
improvement over available therapy.1 The
EMA designation provides scientific and regulatory support for
medicines that have the potential to address significant unmet
medical need.2
Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology &
Inflammation (RI&I), and Head of Translational &
Development Sciences, GSK, said:
"MASH affects millions of people worldwide and is one of the
leading causes of liver transplant in the US and Europe, but
treatment options are limited for most and non-existent for those
with the most advanced form of disease. These designations
recognise efimosfermin's potential and reflect GSK's accelerating
momentum in liver health. We believe efimosfermin has the potential
to significantly advance the standard of care by directly targeting
liver fibrosis."
The two designations were supported by data from MASH patients with
moderate to advanced (F2/F3) and cirrhotic (F4) fibrosis. This
includes phase II data at 48 weeks for F2/F3 patients who showed
fibrosis improvement and MASH resolution with once-monthly
efimosfermin versus placebo. Data also confirmed a well-tolerated
safety profile with mild, transient adverse events, including
nausea, vomiting, and diarrhoea.3,4 Efimosfermin
is currently in phase III with the ZENITH-1 and ZENITH-2 trials
investigating efficacy and safety in MASH patients with F2/F3
fibrosis. Phase III trials in MASH patients with F4 fibrosis are
expected to start this year.
MASH is a chronic, progressive liver disease that affects up to 5%
of the global population and is a leading cause of liver
transplants in both the US and Europe.5-7 The
buildup of scar tissue, or fibrosis, is a key predictor of serious
outcomes for patients, including cirrhosis, liver failure and liver
cancer.8 Currently,
liver-specific treatment options are limited for those with
moderate to advanced fibrosis and there are no approved treatments
for cirrhotic MASH (F4).8
About efimosfermin
Efimosfermin is an investigational, once-monthly subcutaneous
injection of a long-acting variant of FGF21 that is designed to
regulate key metabolic pathways to decrease liver fat, ameliorate
liver inflammation, and reverse liver fibrosis in patients with
MASH. Efimosfermin is currently in trials for moderate to
advanced fibrosis, including cirrhosis, and is not available for
prescription anywhere in the world.
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, 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 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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Sydney Dodson-Nease
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+1 215 370 4680
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(Philadelphia)
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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
2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1 U.S. Food &
Drug Administration.
Breakthrough Therapy. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.
Last accessed: 16 April 2026.
2 European Medicines Agency.
PRIME: Priority Medicines. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines. Last
accessed: 16 April 2026.
3 Noureddin M, Kowdley K, Odrljin
T et
al. Efimosfermin alfa (BOS-580)
once per month in people with metabolic dysfunction-associated
steatohepatitis with F2 or F3 fibrosis: results from a 24-week,
randomised, double-blind, placebo-controlled, phase 2
trial. Lancet, 2026; 407: 794-804.
4
Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With
F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study.
Gastroenterol Hepatol (N Y). 2025 Dec;21(12 Suppl 11):7-9. PMID:
41660650; PMCID: PMC12879048.
5 Povsic
M, et al. A Structured Literature Review of the Epidemiology and
Disease Burden of Non-Alcoholic Steatohepatitis (NASH). Advances in
Therapy. 2019;36(7):1574-94. DOI:
10.1007/s12325-019-00960-3.
6
Paklar N, Mijic M, Filipec-Kanizaj T. The Outcomes of Liver
Transplantation in Severe Metabolic Dysfunction-Associated
Steatotic Liver Disease Patients. Biomedicines.
2023;11(11):3096.
7
Younossi Z, Germani G, Wong R, et al. Steatotic liver disease is
the dominant indication for liver transplantation in both Europe
and the United States: Trends and outcomes in the past 2 decades.
Liver Transplantation. 2026;32(4):549-557. DOI:
10.1097/LVT.0000000000000688.
8 Miller
DM, McCauley KF, Dunham-Snary KJ. Metabolic
Dysfunction-Associated Steatotic Liver Disease (MASLD): Mechanisms,
Clinical Implications and Therapeutic Advances. Int
J Mol Sci. 2024;25(10):5487. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12627968/. Last
accessed: 16 April 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: April,
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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