GSK Stock Near 52‑Week High as FDA Decisions and CEO Transition Loom (LON:GSK, NYSE:GSK)

GSK Stock Near 52‑Week High as FDA Decisions and CEO Transition Loom (LON:GSK, NYSE:GSK)

GSK plc’s share price is pressing against 52‑week highs as 2025 draws to a close, with investors weighing a cluster of near‑term FDA decisions, a major CEO change on 1 January 2026, and a still‑busy share buyback programme.

As of 4 December 2025, GSK shares on the London Stock Exchange trade at 1,836.5p, within a day range of 1,827–1,839p and a 52‑week range of 1,242.5–1,848.5p. [1] The New York–listed ADR (NYSE:GSK) closed on 3 December at $48.97, just below its 52‑week high of $49.31 and well above its 52‑week low of $31.72. [2]

That puts GSK stock roughly 50% above its one‑year low on both sides of the Atlantic, after a year defined by strong specialty‑medicine growth, revived oncology momentum and a big legal overhang starting to clear.


GSK share price today: riding the upper end of the 2025 range

On 4 December, LON:GSK is trading at 1,836.5p, up modestly from the previous close of 1,833p. [3]

Key trading metrics:

  • Day range (4 Dec 2025): 1,827.0–1,839.0p
  • 52‑week range: 1,242.5–1,848.5p
  • ADR last close (3 Dec 2025): $48.97, with pre‑market quotes nudging above $49. [4]

The move caps a powerful recovery from 2024’s litigation‑heavy period. GSK’s valuation has re‑rated as investors focus less on Zantac risk and more on a pipeline cluster in respiratory, infectious disease, oncology and HIV.


Q3 beat and upgraded 2025 guidance

The inflection point for sentiment came with Q3 2025 results on 29 October.

According to Reuters, GSK:

  • Raised its 2025 outlook, now guiding for:
    • Revenue growth of 6–7% (up from 3–5%)
    • Core EPS growth of 10–12% (up from 6–8%) [5]
  • Reported core EPS of 55p on sales of £8.55bn, beating analyst expectations of 47.1p on £8.24bn. [6]
  • Saw its shares jump nearly 7% on the day, to the highest level since May 2024. [7]

Growth was driven by double‑digit gains in specialty HIV and oncology medicines, while vaccines remained mixed. Global vaccine sales in Q3 reached £2.68bn, ahead of forecasts, but U.S. shingles vaccine Shingrix sales fell 15% amid a weaker domestic vaccination environment and increased competition. [8]

Underlying 2024 performance

Full‑year 2024 results, reported in February 2025, showed that the litigation charge masked solid operating momentum:

  • 2024 sales: £31.4bn, up 7% at constant exchange rates (CER).
  • Specialty medicines: +19% (HIV +13%, oncology +98%, respiratory/immunology +13%).
  • General medicines: +6%.
  • Vaccines: ‑4% overall, with Shingrix up 1% but RSV vaccine Arexvy down sharply as post‑launch demand normalised.
  • Core EPS: 159.3p, +10% CER, while Total EPS fell 40% due mainly to a £1.8bn Zantac settlement charge. [9]

This combination—accelerating underlying growth plus reduced litigation uncertainty—is a big part of why GSK stock has outperformed many European pharma peers in 2025. [10]


December 2025 FDA calendar: three big catalysts

December is shaping up as a high‑stakes month for GSK’s pipeline, with three U.S. regulatory events in focus.

1. Blenrep: blood cancer comeback in the U.S.

GSK’s antibody–drug conjugate Blenrep (belantamab mafodotin), once withdrawn from the U.S. market, is now officially back.

On 23 October 2025, the U.S. FDA approved Blenrep in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma, clearing the way for a market re‑entry nearly three years after withdrawal. [11]

GSK has previously guided for potential peak sales of up to £3bn for Blenrep if combination regimens perform as hoped, making the U.S. relaunch a key test of its oncology ambitions.

Separately, a fresh GSK press release ahead of the ASH 2025 haematology conference highlights long‑term data from its DREAMM programme (DREAMM‑7, ‑8 and ‑9), showing sustained benefits of Blenrep‑based regimens and new analyses for momelotinib in myelofibrosis. [12]

2. Depemokimab: ultra‑long‑acting asthma biologic (PDUFA 16 December)

Depemokimab, an IL‑5–targeting biologic, could be one of GSK’s most important mid‑term assets.

  • The FDA accepted GSK’s biologics licence applications (BLAs) in March 2025 for:
    • Severe asthma with an eosinophilic phenotype in patients ≥12 years
    • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults [13]
  • The agency set a Prescription Drug User Fee Act (PDUFA) date of 16 December 2025. [14]

Phase 3 SWIFT and ANCHOR trials showed significant reductions in asthma exacerbations and hospitalisations, and depemokimab would be the first ultra‑long‑acting biologic with 6‑monthly dosing in its indications if approved. [15]

3. Gepotidacin (Blujepa): new oral antibiotic for gonorrhoea (PDUFA 11 December)

GSK is also pushing gepotidacin (Blujepa) further into infectious disease:

  • Gepotidacin was approved in March 2025 for certain uncomplicated urinary tract infections (uUTI). [16]
  • In August 2025, the FDA accepted a supplemental NDA for uncomplicated urogenital gonorrhoea and granted priority review.
  • The FDA set an 11 December 2025 PDUFA date for the gonorrhoea indication. [17]

Given the rise of antibiotic resistance and the lack of new oral options for gonorrhoea, a positive decision could be strategically important even if near‑term revenue is modest.

Why December matters for the GSK stock story

Bank of America recently argued that 2026 will be unusually busy for GSK, with:

  • Launch ramp‑up for Blenrep and depemokimab
  • Three key pipeline events: an HIV investor day, Phase 3 data for camlipixant in chronic cough and bepirovirsen in hepatitis B

BofA raised its GSK price objective to 2,000p and forecast 2026 sales of £275m for Blenrep and £340m for depemokimab, ahead of Visible Alpha consensus, while still rating the shares only “Neutral” given the long‑term challenge of offsetting HIV patent expiries. [18]


CEO change: Luke Miels inherits a higher‑growth GSK

GSK enters this catalyst‑heavy period amid a leadership transition.

  • Emma Walmsley, CEO since 2017, will step down on 31 December 2025 after eight years at the helm. [19]
  • Luke Miels, currently Chief Commercial Officer, has been named CEO‑designate and will assume full CEO responsibilities and join the board on 1 January 2026. [20]

Walmsley’s tenure included the 2022 spin‑off of consumer‑health unit Haleon, a refocusing on vaccines and specialty medicines, and the controversial but ultimately stabilising Zantac settlement. [21]

Despite criticism about R&D performance early in her tenure, GSK’s specialty portfolio has grown markedly, and shares have rebounded in 2025 after lagging peers for years. [22]

Miels, an Australian biopharma veteran with stints at AstraZeneca, Sanofi and Roche, is widely seen as a commercially aggressive operator. Reuters notes he now has to deliver on GSK’s headline ambition of more than £40bn in annual revenue by 2031, compared with analyst consensus closer to £34bn. [23]


Tariffs, trade and U.S. expansion strategy

Macro policy has been an unusually important variable for GSK in 2025.

Earlier this year, the Trump administration’s threat of a 100% tariff on imported branded drugs sent global pharma scrambling to increase U.S. manufacturing and inventory. GSK responded by planning to invest $30bn in U.S. R&D and supply‑chain infrastructure over five years, part of a broader scramble by drugmakers to avoid tariff exposure. [24]

That risk has since eased. On 1 December 2025, the U.S. and UK announced a zero‑tariff deal for British pharmaceutical products and medical technology, in exchange for Britain:

  • Agreeing to pay more for medicines (a 25% increase in net prices for new U.S. drugs)
  • Raising the cost‑effectiveness threshold at NICE from £30,000 to £35,000 per quality‑adjusted life‑year. [25]

GSK welcomed the deal, calling it an opportunity to secure the UK as an attractive environment for life sciences investment. [26]

For investors, the takeaway is that tariff risk has been replaced by pricing risk: better visibility on cross‑border trade, but a UK health system now committed to paying more for innovative medicines, which supports industry revenues but may generate political friction.


Zantac litigation: big bill paid, overhang reduced

The long‑running Zantac (ranitidine) litigation has loomed over GSK’s investment case for several years. That overhang is now much smaller, though not totally gone.

Key milestones:

  • October 2024: GSK agreed to settle about 80,000 U.S. state‑court Zantac lawsuits for up to $2.2bn, plus $70m to resolve a related whistleblower case. The company recorded a £1.8bn charge in Q3 2024 but said the settlements would not affect its R&D or growth plans. [27]
  • July 2025: The Delaware Supreme Court ruled that the trial judge had applied an overly lenient standard in allowing plaintiffs’ expert testimony and ordered stricter scrutiny, a decision widely viewed as a major win for GSK and other Zantac defendants. [28]

While most U.S. product‑liability cases are now settled or dismissed, some state‑court matters and a securities‑fraud class action remain. A filing by plaintiffs’ law firm Kessler Topaz notes that briefing on GSK’s motion to dismiss the securities case—alleging it misled investors on Zantac risks—was scheduled to be completed by 4 December 2025, making a court ruling a potential 2026 catalyst. [29]

Overall, the tail risk of a catastrophic Zantac judgment has fallen sharply, but legal noise has not disappeared entirely.


Dividends, buybacks and valuation

Dividend profile

GSK continues to emphasise cash returns.

According to StockInvest and company disclosures, GSK has declared quarterly dividends of 16p per share throughout 2025, payable in April, July, October 2025 and January 2026. [30]

That implies:

  • Annual dividend: 64p per share
  • Forward dividend yield: roughly 3.5% based on the 1,836.5p share price on 4 December 2025. [31]

Share buyback programme

GSK is also executing a sizeable share buyback programme.

A Form 6‑K filed on 2 December 2025 shows that the company:

  • Repurchased 200,000 ordinary shares that day at a volume‑weighted average price around 1,815p.
  • Has bought back about 11.55m shares since 30 September 2025 under the current programme.
  • Now holds around 237m shares in treasury, representing 5.81% of total voting rights out of 4.078bn shares outstanding. [32]

Buybacks help offset share‑based compensation and modestly boost EPS, but also signal confidence in the company’s cash‑generation outlook.

Valuation snapshot

Using 2024 core EPS of 159.3p, the 1,836.5p share price implies a trailing core P/E multiple of about 11.5x. [33]

That still leaves GSK trading at a discount to many large global pharma peers, which often command mid‑teens earnings multiples, even after the stock’s strong 2025 run. The discount reflects lingering scepticism about long‑term growth versus the HIV patent cliff and the risk that GSK may turn to value‑dilutive M&A to close its 2031 revenue gap. [34]


Analyst ratings and GSK stock forecasts

ADR consensus: neutral with limited upside

Data from Investing.com show that, for the NYSE‑listed ADR:

  • 8 analysts currently cover GSK.
  • The consensus rating is “Neutral”, with:
    • 2 Buy
    • 5 Hold
    • 1 Sell
  • The average 12‑month price target is $49.35, just 0.8% above the latest close, with a range of $40 to $58. [35]

In other words, the sell‑side sees limited further upside near term, but does not view the stock as obviously overvalued.

London listing: hold ratings and a modest downside skew

For the London‑listed shares (LON:GSK), MarketBeat data indicate:

  • A consensus “Hold” rating from five research firms.
  • An average target price of 1,762p, with a range of 1,450–2,100p. [36]

Against the current 1,836.5p price, that average target implies low‑single‑digit downside on capital alone, although total return improves once the ~3.5% dividend yield is included. [37]

BofA and the 2031 growth puzzle

Bank of America’s recent note is a good illustration of how many analysts see GSK:

  • It raised its target to 2,000p and upgraded the stock to Neutral, not Buy. [38]
  • It argues that consensus underestimates the revenue potential of Blenrep and depemokimab, forecasting 2026 sales ahead of Visible Alpha estimates. [39]
  • Yet it emphasises that even successful execution still leaves a sizable gap between GSK’s >£40bn 2031 revenue goal and current consensus around £32–34bn, a gap some investors fear might be filled via riskier M&A. [40]

Technical view: AI models see further upside, with caveats

From a purely technical standpoint, algorithmic models are currently bullish.

StockInvest’s AI‑driven analysis of GSK.L as of the close on 3 December 2025 concludes:

  • The stock is in a strong short‑term rising trend and has been a “Buy” or better since 18 September 2025, rising about 24% over that period.
  • It recently upgraded GSK from “Buy candidate” to “Strong Buy candidate” after the latest session.
  • Short‑ and long‑term moving averages both flash buy signals, with support flagged around 1,807p and 1,752p, and accumulated volume support near 1,794p. [41]

Its model projects that, if the current trend persists, GSK could rise roughly 26% over the next three months, landing in a 2,295–2,472p range with 90% probability, while recommending a suggested stop‑loss near 1,742p. [42]

These projections are, of course, statistical extrapolations of recent price action—not fundamental valuations—and actual returns can deviate sharply if December’s regulatory events or macro conditions surprise.


Key risks for GSK stock

Even with momentum on its side, several risks remain central to the GSK investment thesis:

  • HIV patent cliff: HIV therapy dolutegravir and related regimens contribute a substantial slice of revenue but will face U.S. patent erosion from 2028. GSK is betting that long‑acting injectables and pipeline assets can cushion the blow; skeptics doubt they’ll be enough. [43]
  • Vaccine sentiment and competition: U.S. vaccine sales have already shown vulnerability, with Shingrix down double digits in the U.S. amid political headwinds and competition. [44]
  • Pipeline execution: The December PDUFA decisions for depemokimab and gepotidacin, plus 2026 data for camlipixant and bepirovirsen, are genuine swing factors. Any safety signals or weaker‑than‑expected efficacy could hurt both sentiment and long‑term growth assumptions. [45]
  • M&A risk: Reuters’ Breakingviews has warned that the gap between GSK’s revenue ambitions and consensus forecasts raises the odds of “risky M&A” to buy growth. Deals can create value—but they can just as easily destroy it if valuations are stretched. [46]
  • Residual litigation and regulatory risk: While Zantac product‑liability risk is much lower, securities litigation is ongoing, and political scrutiny of drug pricing remains intense in both the U.S. and UK. [47]

Bottom line: a stronger GSK, but expectations are catching up

By 4 December 2025, GSK looks materially stronger than it did just 18 months ago:

  • The Zantac overhang is largely priced and provisioned.
  • Specialty medicines—especially oncology and HIV—are delivering solid growth.
  • The company has a cluster of near‑term catalysts in Blenrep, depemokimab and gepotidacin.
  • Tariff risks have eased with the U.S.–UK zero‑tariff deal, and GSK continues to return cash via dividends and buybacks.

Against that, the share price already discounts a lot of good news. Sell‑side analysts remain mostly neutral, with price targets hugging current levels, and the long‑term challenge of replacing HIV revenues—and possibly avoiding expensive acquisitions—still unresolved.

For investors following GSK stock into 2026, the story from here is likely to be dominated by:

  1. December FDA decisions,
  2. Luke Miels’ strategic update as new CEO, and
  3. Whether early pipeline wins can convince the market that GSK’s 2031 revenue target is realistic without balance‑sheet‑stretching M&A.

References

1. www.investing.com, 2. www.investing.com, 3. www.investing.com, 4. www.investing.com, 5. www.reuters.com, 6. www.reuters.com, 7. www.reuters.com, 8. www.reuters.com, 9. www.gsk.com, 10. www.reuters.com, 11. www.gsk.com, 12. www.gsk.com, 13. www.gsk.com, 14. www.gsk.com, 15. www.patientcareonline.com, 16. www.urologytimes.com, 17. us.gsk.com, 18. au.investing.com, 19. apnews.com, 20. www.gsk.com, 21. www.theguardian.com, 22. www.reuters.com, 23. www.reuters.com, 24. www.reuters.com, 25. www.reuters.com, 26. www.reuters.com, 27. www.gsk.com, 28. www.reuters.com, 29. www.ktmc.com, 30. stockinvest.us, 31. www.investing.com, 32. www.stocktitan.net, 33. www.gsk.com, 34. www.reuters.com, 35. www.investing.com, 36. www.marketbeat.com, 37. www.investing.com, 38. au.investing.com, 39. au.investing.com, 40. www.reuters.com, 41. stockinvest.us, 42. stockinvest.us, 43. www.reuters.com, 44. www.reuters.com, 45. www.gsk.com, 46. www.reuters.com, 47. www.reuters.com

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