aibioGSK
GSK is a British drugmaker that sells vaccines and medicines for HIV, respiratory disease, cancer and liver disease.
- Ticker
- GSK
- Listing
- LSE, United Kingdom
- Next date
- November 27, 2026
- Chief executive
- Luke Miels
Desk view · Opinion · Updated Oct 22, 2026
GSK is buying its way past the HIV cliff, and the early approvals are landing
GSK has turned its pipeline around quickly, with US approvals for Jideytro, Jemperli in rectal cancer and Hibsago since July. The cost is more debt and higher R&D spending just before its dolutegravir HIV franchise starts to lose exclusivity in 2028.
Read the full desk viewaibio.space Investor Rank · Opinion
8/10 Positive view
Three US approvals in four months and a filed drug with a November decision support GSK, while rising debt meets the dolutegravir exclusivity loss from 2028.
- Technology
- 2/2
- Odds
- 2/2
- Balance sheet
- 1/2
- Risk
- 1/2
- Momentum
- 2/2
Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. How the rank works.
- Technology
- Broad and refreshed. Approvals in lung cancer, rectal cancer and hepatitis B in four months, plus a B7-H3 ADC with phase 3 survival data in China.
- Odds
- Good near term. Neladalkib is filed with a November 27 decision date, though Ris-Rez still needs a global phase 3.
- Balance sheet
- Profitable, more leveraged. £3.11 billion in cash and liquid investments against £15.13 billion net debt at June 30, 2026.
- Main risk
- HIV patent cliff. Dolutegravir drugs lose exclusivity from 2028, while R&D spending and deal debt rise.
- Watch next
- Neladalkib FDA decision on November 27, 2026. Then Exdensur OCEAN data and the pace of phase 3 starts.
Top news on GSK
Questions investors ask
What is aibio.space's Investor Rank for GSK?
8 out of 10, our positive view. Three US approvals in four months and a filed drug with a November decision support GSK, while rising debt meets the dolutegravir exclusivity loss from 2028. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. Source
What did GSK pay for Nuvalent?
GSK paid $124 per share in cash, about $10.6 billion in equity value, or about $9.4 billion net of cash acquired. The deal closed on July 15, 2026. Source
Is Jemperli approved for rectal cancer?
Yes. On October 19, 2026, GSK said the FDA granted accelerated approval to Jemperli for adults with stage II and III dMMR/MSI-H locally advanced rectal cancer, based on the AZUR-1 trial. Source
Why did GSK stop camlipixant?
CALM-1 met its primary endpoint but CALM-2 did not, and secondary endpoints missed in both trials. GSK said the limited efficacy was unlikely to transform patient care and stopped development in chronic cough. Source
When does GSK's dolutegravir patent expire?
GSK refers to a loss-of-exclusivity period for dolutegravir from 2028 to 2030. Dolutegravir products sold £1.44 billion in the second quarter of 2026. Source
What is Ris-Rez?
Risvutatug rezetecan is a B7-H3-targeted antibody-drug conjugate GSK licensed from Hansoh Pharma. In a Chinese phase 3 it cut the risk of death by 54% against topotecan in relapsed small cell lung cancer. Source
Is GSK a smaller reporting company?
SEC records list GSK plc's filer category as: Large accelerated filer. Source
Where is GSK headquartered?
SEC records list its business address as 79 NEW OXFORD STREET, LONDON, WC1A 1DG. Source
What did GSK last file with the SEC?
Its most recent filing in our record is a 6-K filed 2026-10-21. All of its filings are on SEC EDGAR. Source
What was GSK called before?
SEC records list these former names: GLAXOSMITHKLINE PLC. Source
What industry is GSK in?
Its SEC industry code (SIC 2834) is Pharmaceutical Preparations. Source
Legal and investor matters
- Litigation
GSK and AstraZeneca settle Zejula royalty dispute
GSK reported that in July 2026 the parties agreed to settle the Zejula royalty dispute with AstraZeneca. AstraZeneca sued Tesaro, now a GSK subsidiary, in the High Court of England and Wales in May 2021, alleging unpaid royalties under two 2012 licence agreements. The Court of Appeal ruled for GSK in February 2024, and the UK Supreme Court refused permission to appeal in May 2024. GSK states the matter has concluded.
- Litigation
Delaware court grants summary judgment in remaining Zantac cases, plaintiffs appeal
GSK reports that on 2026-04-13 the Delaware Superior Court granted summary judgment in all remaining Zantac cases filed on or before 2025-12-01, because plaintiffs had not shown general causation. Plaintiffs filed a notice of appeal on 2026-05-13, which applies to six GSK cases. Appeals of about 14,000 dismissed federal MDL cases remain pending at the Eleventh Circuit, with a decision now expected in the second half of 2026.
- Litigation
Tesaro v. AnaptysBio trial held in Delaware Chancery, decision expected by early 2027
GSK reports that the trial in Tesaro, Inc. v. AnaptysBio was held before the Delaware Chancery Court on 2026-07-14 to 2026-07-17. The court asked for post-trial briefs ahead of a post-trial hearing scheduled for 2026-10-20. GSK states a decision is expected in the fourth quarter of 2026 or the first quarter of 2027. The filing does not describe the claims.
- Litigation
Third Circuit vacates class certification in Avandia payor case
GSK's Q2 results report that on 2026-07-21 the Third Circuit Court of Appeals vacated the district court's decision certifying a class in the Avandia third-party payor litigation. The court set out the legal and evidentiary requirements the plaintiffs must satisfy to proceed as a class and remanded the case for further proceedings. The two class actions were filed in 2010 and assert RICO and state consumer protection claims.
- Class action
Zantac securities class action against GSK dismissed with prejudice
A putative securities class action was filed on 2025-02-04 in the Eastern District of Pennsylvania against GSK and certain officers on behalf of purchasers of GSK securities from 2020-02-05 through 2022-08-14. The complaint alleges materially false or misleading statements or omissions about Zantac. Plaintiffs amended it on 2025-07-07, removing one individual defendant and changing the class period to 2020-02-05 through 2022-08-12. On 2026-03-04 the court granted GSK's motion to dismiss and dismissed the amended complaint with prejudice.
- Litigation
GSK and Teva settle Coreg patent case after $235.51 million jury award
GSK says it reached a confidential settlement with Teva on 2026-02-09, resulting in dismissal with prejudice of the Coreg patent action. GSK sued Teva in 2014 for inducing infringement of a carvedilol patent. A 2017 jury awarded $235.51 million, which the Federal Circuit reinstated, and the Supreme Court denied Teva's petition in May 2023. GSK states the matter is concluded.
- Litigation
GSK patent suits against Pfizer, BioNTech and Moderna over mRNA vaccines proceed
GSK has sued Pfizer and BioNTech over Comirnaty and Moderna over Spikevax, mNEXSPIKE and mRESVIA in the District of Delaware, the Unified Patent Court and other courts. The Delaware trials are scheduled for 2027-06-07 against Pfizer and BioNTech, 2027-07-19 against Moderna over its COVID-19 vaccines and 2027-08-23 over Moderna's RSV vaccine. Pfizer and BioNTech filed a UK revocation suit, with trial listed for 2027-02-22.
- Regulatory
GSK signs $70 million settlement of Zantac qui tam complaint
GSK reports that on 2024-10-09 it reached an agreement in principle to pay a total of $70 million to resolve the Zantac qui tam complaint previously filed by Valisure. The Department of Justice and participating State Attorneys General approved it, and it was signed on 2025-04-03. The qui tam complaint has been dismissed.
- Litigation
GSK and Pfizer settle all RSV vaccine patent litigation
GSK reports that on 2025-04-01 it and Pfizer reached a global settlement of all RSV vaccine patent litigation. Pfizer received a worldwide licence to certain GSK patents on recombinant RSV prefusion F protein, and GSK receives a royalty stream on sales of Abrysvo. The Delaware case was dismissed on 2025-04-04, and cases in other jurisdictions were also dismissed.
- Regulatory
Arizona attorney general sues GSK over Flovent
The Arizona Attorney General filed a lawsuit in Arizona state court on 2025-02-06 alleging GSK engaged in deceptive and unfair practices over Flovent in violation of the state consumer protection statute. GSK removed the case to federal court, which remanded it to state court on 2025-08-26. The state court heard argument on GSK's motion to dismiss on 2026-01-23.
Pipeline
| Program | Indication | Stage |
|---|---|---|
| Neladalkib (NVL-655) | ALK-positive non-small cell lung cancer | Under FDA review, decision Nov 27, 2026 Source |
| Risvutatug rezetecan (Ris-Rez, B7-H3 ADC) | Extensive-stage small cell lung cancer; prostate cancer | Phase 3 (EMBOLD SCLC-301 ongoing) Source |
| Jemperli (dostarlimab) | dMMR/MSI-H locally advanced rectal cancer | FDA accelerated approval Oct 2026 Source |
| Jideytro (zidesamtinib) | ROS1-positive NSCLC, first line | Registrational data presented Sep 2026; approved in pretreated patients Source |
| Cabenuva (cabotegravir + rilpivirine) | HIV in people with viremia | Phase 3b CROWN met primary endpoint Source |
| Exdensur (depemokimab) | OCEAN phase 3 program | Phase 3 readout expected H2 2026 Source |
Opinion · Devil's advocate
Fact-check-o-meter
GSK's messaging is mostly consistent with its filings, though the early lung-cancer response rate is a thin base
GSK's results announcement matches its press releases on the camlipixant failure, the Nuvalent deal and its legal matters, and it discloses its litigation plainly. The softer spots are emphasis: a 61% response rate drawn from 18 evaluable patients, and a reaffirmed guidance range whose text puts core EPS growth in the lower half.
Science · weight medium
Ris-Rez 61% response rate is 11 of 18 patients in an open-label phase 1
The company said: "61% among evaluable patients at the 8 mg/kg dose (n=11/18; 95% CI: 35.7-82.7)" source
The record says: The release calls EMBOLD PanTumour-101 a "global, open-label phase Ia/b study" and says "longer follow-up will be needed to further characterise the durability of response." The 6 mg/kg arm had a 32% response rate. ClinicalTrials.gov lists the study as Phase 1, non-randomized, with no masking, and its primary outcomes include confirmed objective response rate in Phase 1b. source
Our view: The 61% figure is the better of two doses, in a small group, with about 100 days of median follow-up and no duration or survival data. It supports moving to a phase 3, which GSK has started, but it cannot be compared with other drugs' pivotal results.
Science · weight medium
Jemperli approval rests on a single-arm trial; two response figures differ
The company said: "68% of evaluable patients (98/144; 95% CI: 60%, 76%) achieved cCR12" source
The record says: The same release describes AZUR-1 as an "open-label, single-arm, registrational phase II trial" and gives the independently reviewed figure as "47% (54/116) (95% CI: 37%, 56%)". ClinicalTrials.gov lists the primary outcome as sustained complete clinical response for 12 months "as assessed by Independent Central Review (ICR)" in a single-group study of 154 participants. source
Our view: The release reports both numbers, which is fair. The registry's primary endpoint is the independently assessed one, so 47% is the figure the trial was designed around, though the release says those data continue to mature and that 38 more participants have a clinical complete response but have not yet reached 12 months. Accelerated approval without a control arm leaves long-term benefit unproven.
Press release vs filing · weight low
Camlipixant: the July release and the quarterly report agree
The company said: "CALM-2 did not reach statistical significance in the same primary endpoint with 50mg twice daily at week 24." source
The record says: The Q2 announcement says camlipixant "demonstrated limited efficacy in the CALM-1 and CALM-2 pivotal trials" and reports that Total EPS fell 69% "driven by higher impairments, primarily related to camlipixant of £1.3 billion". source
Our view: The July release was candid that one of two trials missed and did not mention the financial cost; the quarterly report supplied it eleven days later. No gap beyond timing.
Press release vs filing · weight low
Guidance 'reaffirmed' while core EPS growth sits in the lower half of the range
The company said: "2026 guidance reaffirmed with expected growth in: turnover 3% to 5%; Core OP 7% to 9%; Core EPS 7% to 9%" source
The record says: Later in the same announcement: "Core earnings per share is also expected to increase at the lower half of the range between 7 to 9 per cent at CER, reflecting higher interest charges of around £800 million, including the impact of the Nuvalent acquisition." The June deal release said GSK expected "low single-digit percentage dilution to core EPS" for the current year, FY 2027 and FY 2028. source
Our view: The range is unchanged, but the text places core EPS growth in its lower half, citing higher interest charges that include the Nuvalent acquisition and a tax rate expected to rise to about 17.5%, while turnover and core operating profit are placed in the upper half. Net debt was £15.13 billion at June 30, per the same document. The text below the headline range adds detail the range alone does not show.
Legal and disclosure record · weight medium
Product liability and IP matters disclosed; no securities litigation in the update
The record says: The Q2 announcement reports a legal provision of £232 million and lists Zantac ("the Delaware Superior Court issued its decision granting summary judgment as to all remaining cases filed on or before 1 December 2025", plaintiffs appealed 13 May 2026), Avandia (Third Circuit vacated a class certification on 21 July 2026) and Tesaro, Inc. v. AnaptysBio in Delaware Chancery Court, with a decision "expected in Q4 2026 or Q1 2027". source
Our view: These are documented proceedings, not findings against GSK. The Eleventh Circuit decision on the federal Zantac appeals is expected in the second half of 2026, according to the filing.
Documents we compared
- GSK Q2 2026 results announcement (furnished on Form 6-K)
- GSK Ris-Rez first global data in small cell lung cancer release
- GSK Jemperli rectal cancer approval release
- GSK CALM-1 and CALM-2 update release
- GSK agreement to acquire Nuvalent release
- ClinicalTrials.gov NCT06551142 (EMBOLD PanTumour-101)
- ClinicalTrials.gov NCT05723562 (AZUR-1)
Stock chart
SEC filings and registration
- SEC name
- GSK plc
- CIK
- 1131399
- Industry (SIC)
- Pharmaceutical Preparations (2834)
- US tickers
- GSK (NYSE), GLAXF (OTC)
- State or country of incorporation
- X0
- Filer category
- Large accelerated filer
- Business address
- 79 NEW OXFORD STREET, LONDON, WC1A 1DG
- Phone
- 44 20 8047 5000
- Shares outstanding
- 4,315,445,026 as of 2025-12-31 (20-F filed 2026-03-06)
- Former names
- GLAXOSMITHKLINE PLC
Recent filings
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