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: 17 February 2026, London UK
Exdensur (depemokimab)
approved by the European Commission for severe asthma with type 2
inflammation and chronic rhinosinusitis with nasal polyps
● Exdensur is
the first and only ultra-long-acting biologic in the EU to treat
respiratory diseases
● Approval
based on four phase III trials with statistically significant and
clinically meaningful primary data across severe asthma and chronic
rhinosinusitis with nasal polyps (CRSwNP)
● An
estimated 3 million people live with severe asthma in Europe and
patients with CRSwNP face inadequately controlled
symptoms
GSK plc (LSE/NYSE: GSK) today announced the European Commission
has approved Exdensur (depemokimab)
in two indications:
● as add-on maintenance treatment for severe asthma
with type 2 inflammation characterised by blood eosinophil count in
adults and adolescents 12 years and older who are inadequately
controlled despite high dose inhaled corticosteroids (ICS) plus
another asthma controller;
● as an add-on therapy with intranasal
corticosteroids for the treatment of adult patients with severe
CRSwNP for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate disease
control.
The approval is based on data from the SWIFT and ANCHOR phase III
trials, which showed sustained efficacy with a twice-yearly dosing
regimen for depemokimab. Each of the four trials met their primary
or co-primary endpoints with statistically significant and
clinically meaningful results, comparing the addition of
depemokimab to standard of care versus standard of care
alone.1,2
Kaivan Khavandi, SVP, Global Head, Respiratory,
Immunology & Inflammation R&D, GSK,
said: "The
approval of Exdensur in the EU means there is now an innovative
ultra-long-acting option that offers sustained efficacy over 6
months to protect patients from severe asthma exacerbations and the
debilitating symptoms associated with
CRSwNP. Exdensur may help redefine care for the millions of
patients living with these persistent and burdensome conditions,
supporting them in achieving their treatment goals with just two
doses a year."
Asthma affects more than 42 million people in
Europe.3 About
5-10% of patients experience severe asthma with many continuing to
experience exacerbations and reduced quality of life despite
treatment.4 In
addition, patients with CRSwNP face debilitating daily symptoms and
almost half remain uncontrolled.5,6 Exdensur is
a novel therapy that combines high interleukin-5 (IL-5) binding
affinity and high potency with an extended half-life, enabling the
sustained suppression of disease-driving type 2 inflammation with
twice-yearly dosing that could address the continued unmet need in
these diseases.1
Stephanie Korn, MD, PhD, Head of the Clinical Research Centre IKF
Pneumologie Mainz, said: "People
living with the burden of severe asthma face persistent
exacerbations driven by uncontrolled type 2 inflammation. A new
option with twice-yearly dosing that could provide sustained
suppression of type 2 inflammation is a promising innovation for
patients in Europe with severe asthma who are in urgent need of
novel solutions."
Eugenio De Corso, MD, PhD, Professor at University of Perugia,
said: "CRSwNP profoundly
impacts a patient's daily life, causing debilitating nasal
obstruction which can make breathing, smell, sleeping and other
fundamental activities a major challenge. An innovative treatment
option like Exdensur, that
could help patients achieve their treatment goals in fewer doses,
represents an important advance."
In the SWIFT phase III trials treatment with depemokimab resulted
in a significant 58% and 48% reduction in the rate of annualised
asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1
and SWIFT-2, respectively [rate ratio (95% confidence interval)
p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52
(0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1
0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per
year).1
In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated
with depemokimab experienced numerically fewer exacerbations
requiring hospitalisation and/or emergency department visits (1%
and 4%) compared with placebo (8% and 10%), respectively. A
pre-specified pooled analysis of the two trials showed there was a
72% reduction in the annualised rate of clinically significant
exacerbations requiring hospitalisation and/or ED visits over 52
weeks for depemokimab compared with placebo [rate ratio 0.28, 95%
CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus
placebo 0.09).1 The
full results from the SWIFT trials were presented at the
2024 European
Respiratory Society International Conference and
published in the New
England Journal of Medicine.1,7
Additionally, in the ANCHOR phase III trials, treatment with
depemokimab resulted in an improvement (reduction) from baseline in
nasal polyp score (scale: 0-8) at 52 weeks [treatment difference
(95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3)
p<0.001 and ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal
obstruction verbal response scale (scale: 0-3) over weeks 49-52
[treatment difference (95% confidence interval) p-value: ANCHOR-1
-0.23 (-0.46, <0.00) p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03)
p=0.025].2 The
full results from the ANCHOR trials were presented at the
2025 American
Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy
Organization (WAO) Joint Congress and
published in The
Lancet.2,8
Across these trials, depemokimab was well-tolerated, with patients
experiencing a similar rate and severity of side effects as those
receiving placebo.1,2
Exdensur recently
received approval in the US for the treatment of severe asthma, as
well as marketing authorisation in the UK and Japan for the
treatment of severe asthma and CRSwNP.9-11
About the SWIFT phase III trials
The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and
safety of depemokimab adjunctive therapy in 382 and 380
participants with severe asthma who were randomised to receive
depemokimab or a placebo respectively, in addition to their
standard of care (SOC) treatment with medium to high-dose inhaled
corticosteroids plus at least one additional controller. The full
analysis set in SWIFT-1 included 250 patients in the depemokimab
plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252
patients were included in the depemokimab plus SOC arm and 128 in
the placebo plus SOC arm.1
About the ANCHOR phase III trials
ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and
128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were
included in the depemokimab plus SOC arm and 128 in the placebo
plus SOC arm. All 528 patients had inadequately controlled CRSwNP,
including nasal polyps in both nasal cavities (an endoscopic
bilateral NPS ≥5), and had either undergone previous surgery
for CRSwNP, had received previous treatment with SCS or were
intolerant to SCS. Patients received depemokimab or placebo at
six-monthly intervals (26 weeks) in addition to SOC (maintenance
intranasal corticosteroids).2
About Exdensur (depemokimab)
Exdensur is the first ultra-long-acting biologic being
evaluated for certain respiratory diseases with underlying type 2
inflammation, such as severe asthma and CRSwNP. It combines high
interleukin-5 (IL-5) binding affinity and high potency with an
extended half-life to enable twice-yearly
dosing.1,2 IL-5
is a key cytokine in type 2 inflammation.
For product and important safety information please
consult the country's relevant summary of product
characteristics. The EU information is available
at: https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur
About the depemokimab development programme
Depemokimab is currently being evaluated in phase III trials for
the treatment of other diseases with underlying type 2
inflammation, including OCEAN for eosinophilic granulomatosis with
polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome
(HES).12,13 GSK
has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III
trials assessing the efficacy and safety of depemokimab as an
add-on therapy in patients with uncontrolled moderate to severe
COPD with type 2 inflammation.14-16
About GSK in respiratory
GSK continues to build on decades of pioneering work to deliver
more ambitious treatment goals, develop the next generation
standard of care, and redefine the future of respiratory medicine
for hundreds of millions of people with respiratory diseases. With
an industry-leading respiratory portfolio and pipeline of vaccines,
targeted biologics, and inhaled medicines, GSK is focused on
improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood refractory chronic cough
or rarer conditions like systemic sclerosis with interstitial lung
disease. GSK is harnessing the latest science and technology with
the aim of modifying the underlying disease dysfunction
and preventing progression.
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 2024, and
GSK's Q4 Results for 2025.
Registered in England & Wales:
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WC1A
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References
1.
Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with
an Eosinophilic Phenotype. NEJM.
September 2024. Vol. 391 No. 24.DOI: 10.1056/NEJMoa2406673.
2.
Gevaert, Philippe et al. Efficacy and safety of twice per year
depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1
and ANCHOR-2): phase 3, randomised, double-blind, parallel
trials. The
Lancet, Volume
405, Issue 10482, 911 - 926. DOI: 10.1016/S0140-6736(25)00197-7.
3.
International Respiratory Coalition. Asthma. Available
at: https://international-respiratory-coalition.org/diseases/asthma/.
Accessed January 2026.
4. Menzies-Gow,
A., et al. "A
renewed charter: Key principles to improve patient care in severe
asthma." Advances in Therapy, vol. 39, no. 12, 17 Oct. 2022, pp.
5307-5326, https://doi.org/10.1007/s12325-022-02340-w.
5. Maspero,
J, et al. "Type 2 inflammation in asthma and other airway
diseases." ERJ Open
Research, vol.
8, no. 3, July 2022, pp. 00576-02021, https://doi.org/10.1183/23120541.00576-2021.
6. Seys,
S, et al. "Real‐life
assessment of chronic rhinosinusitis patients using mobile
technology: The mysinusitiscoach project by Euforea." Allergy,
vol. 75, no. 11, 19 June 2020, pp.
2867-2878, https://doi.org/10.1111/all.14408.
7.
Jackson, D, et al. "Late breaking abstract - depemokimab
efficacy/safety in patients with asthma on medium/high-dose ICS:
The phase IIIA randomised SWIFT-1/2 studies." European Respiratory
Journal 2024, vol. 64, no. 68, 14 Sept. 2024, https://doi.org/10.1183/13993003.congress-2024.rct3718.
8. Han,
J, et al. Efficacy and Safety of Twice-Yearly Depemokimab in
Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP):
The Phase III Randomized, Double-Blind, Placebo-Controlled
Replicate ANCHOR-1/2 Trials. Journal of Allergy and Clinical
Immunology, Volume 155, Issue 2, AB443. www.jacionline.org
9. "Exdensur
(Depemokimab) Approved by US FDA for the Treatment of Severe
Asthma." GSK, 16 Dec.
2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/.
10. "Exdensur
(Depemokimab) Approved in the UK for Treatment of Asthma with Type
2 Inflammation and Chronic Rhinosinusitis with Nasal
Polyps." GSK, 15 Dec.
2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/.
11. "Exdensur
(depemokimab) approved in Japan for severe asthma and chronic
rhinosinusitis with nasal polyps." GSK, 6 Jan.
2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/.
12. "Efficacy
and Safety of Depemokimab Compared With Mepolizumab in Adults With
Relapsing or Refractory Eosinophilic Granulomatosis With
Polyangiitis (EGPA) (OCEAN)." ClinicalTrials.gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05263934.
Accessed 8 Dec. 2025.
13.
"Depemokimab in Participants With Hypereosinophilic Syndrome,
Efficacy, and Safety Trial (DESTINY)." ClinicalTrials.gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05334368.
Accessed 8 Dec. 2025.
14.
"Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2
Inflammation (ENDURA-1)." ClinicalTrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT06959095.
Accessed 8 Dec. 2025.
15.
"Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2
Inflammation (ENDURA-2)." Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06961214.
Accessed 8 Dec. 2025.
16. eValuating
the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN
Chronic Obstructive Pulmonary Disorder (COPD) With Type 2
Inflammation (VIGILANT)."
Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT07177339.
Accessed 17 Dec. 2025.
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
17, 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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