UNITED STATES<\/p>\n
SECURITIES AND EXCHANGE COMMISSION<\/p>\n
Washington, D.C. 20549<\/p>\n
\n\u00a0<\/p>\n
Form 6-K<\/p>\n
\n\u00a0<\/p>\n
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
\n15d-16<\/p>\n
UNDER THE SECURITIES EXCHANGE ACT OF 1934<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
\nFor the
\nmonth of June 2026<\/p>\n
\n\u00a0<\/p>\n
\nCommission
\nFile Number 001-15170<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
GSK plc<\/p>\n
\n(Translation
\nof registrant’s name into English)<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
79 New Oxford Street, London, WC1A 1DG<\/p>\n
\n(Address
\nof principal executive office)<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
\nIndicate
\nby check mark whether the registrant files or will file annual
\nreports under cover of Form 20-F or Form 40-F.<\/p>\n
\n\u00a0<\/p>\n
\nForm
\n20-F . . . .X. . . . Form 40-F . . . . . . . .<\/p>\n
\n\u00a0<\/p>\n
17 June 2026, London UK<\/p>\n
\u00a0<\/p>\n
Utebzi\u00a0(tebipenem
\npivoxil) approved in the US for adults with complicated urinary
\ntract infections (cUTIs)<\/p>\n
\u00a0<\/p>\n
\n\u25cf\u00a0 First and only oral carbapenem antibiotic approved
\nin the US<\/p>\n
\n\u25cf\u00a0\u00a0Approval
\nbased on PIVOT-PO trial\u00a0demonstrating
\nnon-inferiority compared to intravenous
\ntreatment[1]<\/p>\n
\n\u25cf\u00a0\u00a0More
\nthan 3 million cases of cUTIs are treated annually in the
\nUS[2]\u00a0with
\nup to a third of patients impacted by resistant
\ninfections[3]<\/p>\n
\u00a0<\/p>\n
GSK plc (LSE\/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today
\nannounced that the US Food and Drug Administration (FDA) has
\napproved\u00a0Utebzi,\u00a0an oral\u00a0antibiotic
\nfor the treatment of complicated urinary tract infections (cUTIs)
\nincluding pyelonephritis[i],
\ncaused by certain susceptible pathogens[ii]\u00a0in
\nadult patients who have limited or no alternative oral treatment
\noptions. This is the first and only oral carbapenem antibiotic
\napproved for these patients. This approval is a result of GSK’s
\ndevelopment and exclusive global licensing agreement (excluding
\nselect Asian territories) with Spero
\nTherapeutics.[4]<\/p>\n
\u00a0<\/p>\n
There are more than 3 million cases of cUTI in the US annually and
\ntreatment failure impacts up to 34% of patients.2,3\u00a0Often
\ncaused by multidrug-resistant pathogens,[5]\u00a0these
\ninfections\u00a0account
\nfor\u00a0over
\n$6 billion per year in healthcare costs.[6]\u00a0Carbapenems
\nare the standard treatment for severe or resistant infections, but
\nuntil now have only been available through\u00a0intravenous
\nadministration[7],
\nincreasing hospital resource use and reducing patients’ quality of
\nlife.[8]\u00a0Tebipenem
\npivoxil offers the potential for an effective oral alternative
\ntaken outside of a hospital setting.<\/p>\n
\u00a0<\/p>\n
Tony Wood, Chief Scientific Officer,\u00a0GSK,\u00a0said:
\n“With antibiotic\u00a0resistance\u00a0continuing\u00a0to\u00a0rise,
\npatients and\u00a0healthcare
\nprofessionals\u00a0need
\nnew treatment options. The approval of\u00a0Utebzi\u00a0provides the first and only oral carbapenem
\nantibiotic for appropriate adults with complicated UTIs, a solution
\nthat could help reduce reliance on hospital-based intravenous care
\nand support efforts to address resistant
\ninfections.”<\/p>\n
\u00a0<\/p>\n
Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital,
\nNorthwell Health and Associate Professor of Urology at the Zucker
\nSchool of Medicine at Hofstra\/Northwell, said: “For patients with complicated urinary
\ntract infections (cUTIs) and their caregivers, this approval is a
\nmajor milestone as today’s standard of care places a serious burden
\non them and hospitals. A new effective oral treatment offering an
\nalternative option to intravenous care has the potential to enable
\nmore treatment in the outpatient settings with the ambition to
\nimprove their experience.”<\/p>\n
\u00a0<\/p>\n
Esther Rajavelu, President and Chief Executive Officer, Spero
\nTherapeutics added:\u00a0“The
\nFDA approval of tebipenem pivoxil marks the culmination of more
\nthan a decade of dedication from our team, partners, and, most
\nimportantly, the patients who placed their trust in this program.
\nWe are proud to reach this important milestone. Through our
\npartnership with GSK, we look forward to this much-needed oral
\ntreatment option reaching cUTI patients to help reduce the burden
\nof the disease.”<\/p>\n
\u00a0<\/p>\n
This approval is supported by positive results from the PIVOT-PO
\nphase III trial, which\u00a0demonstrated\u00a0non-inferiority
\nof tebipenem pivoxil compared to intravenous imipenem-cilastatin in
\nhospitalised patients with cUTI, including pyelonephritis, based on
\nthe overall response (composite of clinical cure plus
\nmicrobiological eradication) at the test of cure visit. Tebipenem
\npivoxil (oral, 600 mg) achieved a 58.5% overall success rate
\n(261\/446 participants) compared to 60.2% overall success rate
\n(291\/483 participants) for imipenem-cilastatin (intravenous, 500
\nmg) (adjusted treatment difference: \u22121.3%; 95% CI:
\n\u22127.5%, 4.8%).\u00a0<\/p>\n
\u00a0<\/p>\n
The safety profile of tebipenem pivoxil was generally similar to
\nthat of imipenem-cilastatin and other carbapenem
\nantibiotics.\u00a0The
\nmost frequently reported adverse events (in \u22653% of
\npatients)\u00a0were\u00a0diarrhoea
\nand headache; these events were all mild or moderate and
\nnon-serious.1<\/p>\n
\u00a0<\/p>\n
Tebipenem pivoxil is anticipated to be made available to US
\npatients by the end of 2026. With this approval, GSK builds on
\nrecent advances in its growing anti-infectives
\nportfolio.<\/p>\n
\u00a0<\/p>\n
This approval confirms the successful and productive collaboration
\nbetween GSK and Spero Therapeutics.\u00a0The
\ndevelopment of tebipenem pivoxil has been supported in part with
\nfederal funds from the US Department of Health and Human Services;
\nAdministration for Strategic Preparedness and Response; Biomedical
\nAdvanced Research and Development Authority (BARDA), under contract
\nnumbers HHSO100201800015C and
\nHHSO100201300011C.\u00a0<\/p>\n
\u00a0<\/p>\n
About tebipenem pivoxil\u00a0<\/p>\n
Tebipenem pivoxil was developed in collaboration with Spero
\nTherapeutics4\u00a0for
\nthe treatment of cUTIs, including pyelonephritis. In September
\n2022, GSK entered into an exclusive license agreement with Spero
\nTherapeutics for the development and commercialisation in all
\nmarkets, except certain Asian territories.\u00a0Under
\nthis agreement, GSK sub-licensed back to Spero Therapeutics the
\nrights and responsibility to conduct certain development work,
\nincluding the PIVOT-PO phase III study. The sponsorship of the New
\nDrug Application has been transferred to GSK. As part of the
\nlicense agreement, tebipenem pivoxil has received Qualified
\nInfectious Disease Product and Fast Track designations from the US
\nFDA.\u00a0<\/p>\n
\u00a0<\/p>\n
The US Prescribing Information will be available\u00a0here\u00a0[https:\/\/gskpro.com\/content\/dam\/global\/hcpportal\/en_US\/Prescribing_Information\/Utebzi\/pdf\/UTEBZI-PI-PIL.PDF]<\/p>\n
\u00a0\u00a0<\/p>\n
About the PIVOT-PO trial\u00a0<\/p>\n
The PIVOT-PO trial was a global, randomised, double-blind, pivotal,
\nnon-inferiority (NI margin: -10%) phase III trial evaluating the
\npotential of oral tebipenem pivoxil compared to IV
\nimipenem-cilastatin, in hospitalised adult patients with
\ncomplicated urinary tract infections,\u00a0including
\nacute pyelonephritis. Patients were randomised 1:1 to
\nreceive\u00a0tebipenem
\npivoxil\u00a0(600
\nmg) orally every six hours, or imipenem-cilastatin (500 mg) IV
\nevery six hours, for a total of seven to ten days. Dose adjustments
\nwere made for patients with reduced renal function. Matching
\nplacebos were used to maintain blinding. The primary efficacy
\nendpoint was composite response (combined per-patient clinical cure
\nand microbiological response) at the test-of-cure visit (about 17
\ndays from first dose administration of study drug) in patients with
\nqualifying pathogens susceptible to imipenem. The trial enrolled a
\ntotal of 1,690 patients, with randomisation stratified by age,
\nbaseline diagnosis (cUTI or acute\u00a0pyelonephritis),
\nand the presence or absence of urinary tract instrumentation. For
\nfurther details on the trial, refer to clinicaltrials.gov
\nidentifier NCT06059846.[9]<\/p>\n
\u00a0<\/p>\n
About complicated urinary tract infections
\n(cUTIs)\u00a0<\/p>\n
cUTIs are broadly described as any UTI that carries an increased
\nrisk of morbidity and mortality.5\u00a0Definitions
\nof cUTIs are not currently uniform among international societies
\nand regulatory agencies. cUTIs encompass a heterogeneous patient
\npopulation due to the wide range of host factors, comorbidities and
\nurological abnormalities associated with cUTIs. Risk factors for
\ncUTIs include indwelling catheters, ureteric stents, neurogenic
\nbladder, obstructive uropathy, urinary retention, urinary
\ndiversion, kidney stones, diabetes mellitus, immune deficiency,
\nurinary tract modification and UTIs in renal transplant
\npatients.[10],[11],[12],[13]<\/p>\n
\u00a0<\/p>\n
GSK in infectious diseases\u00a0<\/p>\n
GSK has pioneered innovation in infectious diseases for over 70
\nyears, and the Company’s pipeline of medicines and vaccines is one
\nof the largest and most diverse in the industry, with a goal of
\ndeveloping preventive and therapeutic treatments for multiple
\ndisease areas or diseases with high unmet need globally. Our
\nexpertise and capabilities in infectious disease strongly position
\nus to help prevent and treat disease and potentially mitigate the
\nchallenge of antimicrobial resistance. The approval of tebipenem
\npivoxil continues the momentum for our anti-infectives
\nportfolio.<\/p>\n
\u00a0<\/p>\n
About Spero Therapeutics<\/p>\n
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a
\nclinical-stage biopharmaceutical company focused on identifying and
\ndeveloping novel treatments for rare diseases and diseases with
\nhigh unmet need. For more information, visit\u00a0www.sperotherapeutics.com.<\/p>\n
\u00a0<\/p>\n
About GSK<\/p>\n
GSK is a global biopharma company with a purpose to unite science,
\ntechnology and talent to get ahead of disease together. Find out
\nmore at gsk.com.<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
GSK enquiries<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\nMedia:<\/p>\n
\nSimon
\nMoore<\/p>\n
\n+44 (0)
\n20 8047 5502<\/p>\n
\n(London)<\/p>\n
\u00a0<\/p>\n
\nTim
\nFoley<\/p>\n
\n+44 (0)
\n20 8047 5502<\/p>\n
\n(London)<\/p>\n
\u00a0<\/p>\n
\nKathleen
\nQuinn<\/p>\n
\n+1 202
\n603 5003<\/p>\n
\n(Washington
\nDC)<\/p>\n
\u00a0<\/p>\n
\nAlison
\nHunt<\/p>\n
+1 540 742 3391<\/p>\n
\n(Washington
\nDC)<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\nInvestor
\nRelations:<\/p>\n
\nConstantin
\nFest<\/p>\n
\n+44 (0)
\n7831 826525<\/p>\n
\n(London)<\/p>\n
\u00a0<\/p>\n
\nJames
\nDodwell<\/p>\n
\n+44 (0)
\n20 8047 2406<\/p>\n
\n(London)<\/p>\n
\u00a0<\/p>\n
\nMick
\nReadey<\/p>\n
\n+44 (0)
\n7990 339653<\/p>\n
\n(London)<\/p>\n
\u00a0<\/p>\n
\nSteph
\nMountifield<\/p>\n
\n+44 (0)
\n7796 707505<\/p>\n
\n(London)<\/p>\n
\u00a0<\/p>\n
\nJeff
\nMcLaughlin<\/p>\n
\n+1 215
\n751 7002<\/p>\n
\n(Philadelphia)<\/p>\n
\u00a0<\/p>\n
\nFrannie
\nDeFranco<\/p>\n
\n+1 215
\n751 3126<\/p>\n
\n(Philadelphia)<\/p>\n
Cautionary statement regarding forward-looking
\nstatements<\/p>\n
GSK cautions investors that any forward-looking statements or
\nprojections made by GSK, including those made in this announcement,
\nare subject to risks and uncertainties that may cause actual
\nresults to differ materially from those projected. Such factors
\ninclude, but are not limited to, those described in the “Risk
\nFactors” section in GSK’s Annual Report on Form 20-F for 2025, and
\nGSK’s Q1 Results for 2026.<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
Registered in England & Wales:<\/p>\n
No.
\n3888792<\/p>\n
\u00a0<\/p>\n
\nRegistered Office:<\/p>\n
79
\nNew Oxford Street<\/p>\n
London<\/p>\n
WC1A
\n1DG<\/p>\n
\n\u00a0<\/p>\n
References\u00a0<\/p>\n
\n\u00a0
\n\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<\/p>\n
\n\u00a0<\/p>\n
[i]\u00a0Pyelonephritis
\nis a specific type of UTI that has travelled up the urinary tract
\nto infect one or both kidneys.<\/p>\n
[ii]\u00a0Escherichia
\ncoli, Klebsiella pneumoniae, Enterobacter
\ncloacae\u00a0species
\ncomplex,\u00a0Klebsiella
\noxytoca,
\nand\u00a0Enterococcus
\nfaecalis.<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
[1]\u00a0GSK
\npress release,\u00a0Positive
\nPIVOT-PO phase III data show tebipenem HBr’s potential as the first
\noral carbapenem antibiotic for patients with complicated urinary
\ntract infections (cUTIs), October 2025.<\/p>\n
[2]\u00a0Carreno
\nJJ, et al.\u00a0Longitudinal,
\nnationwide, cohort study to assess incidence, outcomes, and costs
\nassociated with complicated urinary tract
\ninfection.\u00a0Open Forum
\nInfect Dis.
\n2019;7:ofil446. doi: 10.1093\/ofid\/ofz446.<\/p>\n
[3]\u00a0Lodise
\nTP, et al. Retrospective Cohort Study of the 12-Month Epidemiology,
\nTreatment Patterns, Outcomes, and Health Care Costs Among Adult
\nPatients With Complicated Urinary Tract
\nInfections.\u00a0Open Forum
\nInfect Dis.\u00a02022 Jun 20;9(7):ofac307.
\ndoi: 10.1093\/ofid\/ofac307.<\/p>\n
[4]\u00a0GSK
\npress release, GSK and Spero Therapeutics announce exclusive
\nlicence agreement for tebipenem HBr, a late-stage antibiotic that
\nmay treat complicated urinary tract infections, 22 September
\n2022.<\/p>\n
[5]\u00a0Sabih
\nA, Leslie SW. Complicated urinary tract infections
\nin\u00a0StatPearls.
\n2023. StatPearls, Treasure Island, FL, USA.<\/p>\n
[6]\u00a0Lodise
\nTP, et al. Hospital admission patterns of adult patients with
\ncomplicated urinary tract infections who present to the hospital by
\ndisease acuity and comorbid conditions: How many admissions are
\npotentially avoidable?\u00a0Am J Infect
\nControl.
\n2021;49(12):1528-1534.\u00a0<\/p>\n
[7]\u00a0Eckburg
\nPB, et al. Oral tebipenem pivoxil hydrobromide in complicated
\nurinary tract infection.\u00a0New England
\nJournal of Medicine,.2022;386:1327-1338. doi:
\n10.1056\/NEJMoa2105462.<\/p>\n
[8]\u00a0NHS.
\nReducing complications with a prolonged hospital stay.
\n2024.\u00a0Available
\nfrom:\u00a0https:\/\/www.plymouthhospitals.nhs.uk\/display-pil\/pil-reducing-complications-with-a-prolonged-hospital-stay-6686.
\nLast accessed: June 2026.<\/p>\n
[9]\u00a0CT.gov.
\nA Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr)
\nCompared to Intravenous Imipenem-cilastatin in Participants With
\nComplicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis
\n(AP) (PIVOT-PO), last updated on 01 July 2025.<\/p>\n
[10]\u00a0Bonkat G, et
\nal.\u00a0Keep it Simple: A Proposal for a
\nNew Definition of Uncomplicated and Complicated Urinary Tract
\nInfections from the EAU Urological Infections Guidelines
\nPanel.\u00a0Eur
\nUrol.\u00a02024;86(3):195-197.<\/p>\n
[11]\u00a0Wagenlehner
\nFME, et al. Epidemiology, definition and treatment of complicated
\nurinary tract infections.\u00a0Nat Rev
\nUrol.
\n2020;17(10):586-600.<\/p>\n
[12]\u00a0Gomila
\nA, et al. Predictive factors for multidrug-resistant gram-negative
\nbacteria among hospitalised patients with complicated urinary tract
\ninfections.\u00a0Antimicrob
\nResist Infect Control. 2018;7:111.<\/p>\n
[13]\u00a0Altunal
\nN, et al. Ureteral stent infections: a prospective
\nstudy.\u00a0Braz J Infect
\nDis.
\n2017;21(3):361-364.<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
SIGNATURES<\/p>\n
\n\u00a0<\/p>\n
\n\u00a0<\/p>\n
\nPursuant
\nto the requirements of the Securities Exchange Act of 1934, the
\nregistrant has duly caused this report to be signed on its behalf
\nby the undersigned, thereunto duly authorised.<\/p>\n
\u00a0<\/p>\n
GSK plc<\/p>\n
\u00a0<\/p>\n
\n(Registrant)<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\nDate:\u00a0June
\n17, 2026<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\nBy:\/s\/\u00a0VICTORIA
\nWHYTE<\/p>\n
\n————————–<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\nVictoria\u00a0Whyte<\/p>\n
\u00a0<\/p>\n
\nAuthorised
\nSignatory for and on<\/p>\n
\u00a0<\/p>\n
\nbehalf
\nof GSK plc<\/p>\n","protected":false},"excerpt":{"rendered":"UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 \u00a0 Form 6-K \u00a0 REPORT OF FOREIGN PRIVATE ISSUER…\n","protected":false},"author":2,"featured_media":67042,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[20784],"tags":[31325,31321,31322,20684,20785,31323,31324,30869,31320,31319],"class_list":["post-67041","post","type-post","status-publish","format-standard","has-post-thumbnail","category-gsk","tag-6-k-filing","tag-complicated-urinary-tract-infection","tag-cuti","tag-fda-approval","tag-gsk","tag-oral-carbapenem","tag-pivot-po-phase-iii","tag-spero-therapeutics","tag-tebipenem-pivoxil","tag-utebzi"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/116783138924405442","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/67041","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/comments?post=67041"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/67041\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media\/67042"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media?parent=67041"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=67041"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=67041"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}