GSK Stock (LON:GSK, NYSE:GSK): Latest News, FDA Catalysts and 2026 Outlook

GSK plc stock has quietly morphed from a problem child of Big Pharma into one of 2025’s more interesting “value with growth” stories. The shares are trading near multi‑year highs, the company has upgraded guidance, big litigation overhangs are easing, and a cluster of U.S. FDA decisions is about to test how much of that optimism is justified.

As of last night’s close, GSK’s U.S. ADR finished at $48.40, up more than 45% year‑to‑date, while the London‑listed shares recently changed hands around 1,800p, having pushed above their 200‑day moving average of 1,547.73p on heavy volume. ^[1]

Below is a deep dive into the latest news, stock forecasts, pipeline developments and risks as of 11 December 2025.

Share price snapshot and technical picture

A fresh MarketBeat report today highlighted that GSK (LON:GSK) has crossed above its 200‑day moving average, trading as high as 1,808p and last at 1,799.14p. The piece framed that move as a classic bullish technical signal: price above both 50‑day and 200‑day moving averages, on strong volume. ^[2]

Key current metrics from that note:

200‑day moving average: 1,547.73p
50‑day moving average: 1,731.56p
Market cap: ~£72.6bn
Trailing P/E: ~13.5
Beta: 0.31 (less volatile than the broader market)
Leverage: Debt‑to‑equity ~115%, with relatively tight liquidity (quick ratio 0.73; current ratio 0.81) ^[3]

On the U.S. side, MarketBeat’s forecast dashboard shows the ADR at $48.40 (close on 10 December), with an average 12‑month analyst target of $44.13, implying about 9% downside from here based on current Wall Street models. ^[4]

From a momentum perspective:

GuruFocus’ summary of value investor Kahn Brothers’ latest 13F shows they cut their GSK position by ~60% in Q3 2025, after the stock delivered ~27% in the last three months and ~47% year‑to‑date in dollar terms. ^[5]

That’s a neat encapsulation of where GSK sits today: technically strong after a big run, but up far enough that some early value buyers are taking profits while the sell‑side has turned more cautious.

Fundamentals: strong Q3 2025 and upgraded guidance

GSK’s Q3 2025 results, released on 29 October, are the backbone of the current bullish narrative. ^[6]

Headline numbers:

Q3 sales: £8.55bn, +7% at actual exchange rates and +8% at constant currency
Year‑to‑date sales: £24.0bn, +3% AER and +6% CER
Core operating profit: £3.0bn in Q3, up 11% CER
Core EPS: 55.0p in Q3, up 14% CER
Free cash flow: £1.2bn in Q3

Growth was broad‑based:

Specialty Medicines: £3.4bn, +16%, helped by double‑digit growth in respiratory immunology, oncology and HIV. ^[7]
Vaccines: £2.7bn, +2%, with Shingrix shingles vaccine up 13% and RSV vaccine Arexvy up 36% in the quarter. ^[8]
General Medicines: £2.5bn, +4%, led by COPD triple‑therapy Trelegy, up 25%. ^[9]

Crucially, management used this strength to upgrade 2025 guidance:

Turnover growth: now guided to 6–7% (previously “towards the top end” of 3–5%).
Core operating profit growth:9–11% (was 6–8%).
Core EPS growth:10–12% (was 6–8%). ^[10]

The quarter was also boosted by sharply lower legal costs versus prior Zantac‑heavy periods, pushing reported operating margin over 30%. ^[11]

Shareholder returns

Dividend: GSK declared a Q3 dividend of 16p, reaffirming an expected full‑year 2025 dividend of 64p per share. At ~1,800p, that implies a forward dividend yield around 3.5%. ^[12]
Buyback: The company has spent £1.1bn year‑to‑date under the £2bn share buyback programme announced with FY 2024 results. ^[13]

From an income‑plus‑growth perspective, that combination—mid‑single‑digit sales growth, double‑digit EPS growth, and a mid‑3% yield—is the core of the bullish equity story.

Capital allocation: buybacks, treasury shares and today’s block listing

Recent regulatory filings add some colour to GSK’s share‑count dynamics.

On 9 December, GSK disclosed a daily “transaction in own shares”: it repurchased 250,000 shares on the London Stock Exchange as part of the ongoing £2bn buyback. ^[14]
Following recent purchases and transfers to its employee benefit trust, GSK now reports around 238.2m shares held in treasury, representing roughly 5.8% of total issued share capital, with about 4.08bn shares in issue with voting rights. ^[15]

Today, there was a fresh technical but important filing:

On 11 December 2025, GSK announced a block listing application for 250,000 ordinary shares reserved for the 2012 Share Save Plan. These shares will rank pari passu with existing shares once admitted to the Official List on 12 December. ^[16]

Net‑net: buybacks are slowly shrinking the share count and boosting EPS, while periodic block listings and transfers fund employee plans. For long‑term holders, that’s a mild but persistent tailwind.

Leadership transition and the $30bn U.S. bet

Strategically, GSK is on the cusp of a leadership change.

On 29 September 2025, GSK appointed Luke Miels (currently Chief Commercial Officer) as CEO‑designate, effective 1 January 2026, succeeding Dame Emma Walmsley. ^[17]
Walmsley, who became CEO in 2017, will step down on 31 December 2025 but remain with the company during a transition period. ^[18]

Under Walmsley, GSK:

Spun off consumer‑health unit Haleon in 2022.
Re‑oriented the company toward vaccines and specialty medicines, with 15 “scale” pipeline opportunities expected between 2025 and 2031 and a long‑term goal of >£40bn in annual revenue by 2031. ^[19]

The strategy now tilts even harder toward the United States:

In September, GSK committed to invest at least $30bn over five years in the U.S., across R&D, biologics manufacturing and supply‑chain infrastructure, including a new “flex” biologics factory in Pennsylvania. ^[20]

Today, that commitment intersected with some politically sensitive commentary:

In interviews reported by Alliance News, Yahoo Finance and the Yorkshire Post, Walmsley described the U.S. as “the best place to invest” for new drugs and vaccines, even as she reiterated GSK’s commitment to the UK. ^[21]

Those remarks landed the same week the UK government and industry hammered out a new drug‑pricing approach:

A Reuters‑flagged analysis notes that the UK medicine rebate rate on new drugs will fall from 22.5% to 14.5% in 2026, part of a broader UK–US pharma deal involving zero tariffs but higher NHS drug prices. ^[22]
Executives from GSK and AstraZeneca have been invited to help design the successor regime to the much‑criticised VPAG scheme. ^[23]

For GSK shareholders, the message is straightforward: capital and R&D are flowing where pricing and returns look most attractive, and policy risk in the UK is easing but far from gone.

Pipeline and FDA catalysts: Blujepa, Blenrep and depemokimab

A big part of the re‑rating in GSK stock comes from tangible pipeline progress in 2024–25 plus two near‑term FDA decision points in December.

Blujepa (gepotidacin): today’s PDUFA for gonorrhoea

Gepotidacin, marketed as Blujepa, is a first‑in‑class oral antibiotic targeting bacterial type II topoisomerases.
March 2025: FDA approved Blujepa for uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old. ^[24]
11 August 2025: FDA accepted a supplemental NDA for uncomplicated urogenital gonorrhoea with priority review and set a PDUFA action date of 11 December 2025—today. ^[25]

Late‑stage EAGLE‑1 study data in The Lancet showed gepotidacin was non‑inferior to current injectable therapy against Neisseria gonorrhoeae, including resistant strains, with a safety profile consistent with expectations. ^[26]

Status as of this morning: No FDA decision has been publicly announced yet, so the gonorrhoea indication remains a live binary catalyst for GSK in the very near term. ^[27]

If approved, Blujepa would:

Become the first oral option for gonorrhoea in decades.
Strengthen GSK’s infectious‑disease franchise as revenues from some HIV drugs face patent expiries later in the decade. ^[28]

Blenrep (belantamab mafodotin) and hematology at ASH

GSK’s haematology portfolio is front and centre at this week’s American Society of Hematology (ASH) 2025 meeting.

A 1 December press release highlights multiple new datasets for:

Belantamab mafodotin (Blenrep) in relapsed/refractory and newly diagnosed multiple myeloma.
- Long‑term DREAMM‑7 and DREAMM‑8 data suggest sustained progression‑free survival benefits and durable responses. ^[29]
- October 2025: FDA approved Blenrep in combination with bortezomib and dexamethasone for adult patients with relapsed/refractory multiple myeloma after ≥2 prior lines of therapy. Blenrep combos are also approved for 2L+ multiple myeloma in the EU, UK, Japan and other markets. ^[30]
Momelotinib, GSK’s JAK inhibitor for myelofibrosis:
- ASH data reinforce its ability to improve anaemia and spleen volume, with responses linked to better survival outcomes.
- Early ODYSSEY combination‑trial data explore momelotinib + luspatercept, positioning momelotinib as a backbone for future combo regimens. ^[31]

These haematology assets are unlikely to move GSK’s share price overnight, but they feed into the longer‑term thesis that GSK is assembling a credible oncology and rare‑blood‑disease franchise.

Respiratory: Nucala and upcoming depemokimab decision

GSK’s respiratory portfolio is another growth pillar.

In May 2025, FDA expanded Nucala (mepolizumab) to treat eosinophilic COPD, sometimes described as “smoker’s lung.” Late‑stage data showed a 21% reduction in moderate/severe exacerbations versus placebo over 104 weeks. ^[32]

The next big swing is depemokimab, a long‑acting IL‑5–targeting biologic:

March 2025: FDA accepted Biologics License Applications for depemokimab as add‑on maintenance treatment in:
- Asthma with type 2 inflammation (eosinophilic phenotype), and
- Chronic rhinosinusitis with nasal polyps (CRSwNP). ^[33]
PDUFA date:16 December 2025 for both indications. ^[34]

Phase 3 data (SWIFT‑1/2 and ANCHOR‑1/2) show:

About 54% reduction in annualised asthma exacerbation rate versus placebo in patients ≥12.
Statistically significant improvements in nasal polyp scores and nasal obstruction symptoms in CRSwNP. ^[35]
Convenient twice‑yearly subcutaneous dosing, a clear differentiation vs more frequent biologic regimens.

If both Blujepa (gonorrhoea) and depemokimab secure approvals this month, they will reinforce the perception that the “new GSK” has moved beyond restructuring into a pipeline‑delivery phase.

Litigation and legal overhang: Zantac and Jemperli

Zantac (ranitidine) – from crisis to tail risk

The once‑ominous Zantac litigation has been substantially de‑risked over the past 18 months.

October 2024: GSK announced settlements resolving about 80,000 U.S. state‑court Zantac product‑liability cases—around 93% of its state‑court exposure—for up to $2.2bn, plus a separate $70m qui tam settlement. The company booked a ~£1.8bn charge, emphasising no admission of liability and “no change” to its growth agenda. ^[36]
July 2025: The Delaware Supreme Court ruled in favour of Zantac drugmakers including GSK, excluding key plaintiff expert testimony as scientifically unreliable in a case covering nearly 75,000 plaintiffs. This mirrored earlier federal rulings and was widely seen as a major win for the defence. ^[37]

Recent updates from plaintiff‑side trackers show that:

The number of federal multidistrict litigation (MDL) cases fell by more than 400 between October and November 2025, to roughly 1,800 active suits, suggesting ongoing confidential settlements. ^[38]

In short, Zantac has not vanished as a risk, but it now looks like a manageable legal tail, not an existential threat.

Jemperli / AnaptysBio dispute

One newer legal wrinkle involves Jemperli (dostarlimab), a GSK immuno‑oncology drug originally licensed from AnaptysBio.

A late‑November report notes ongoing litigation between GSK’s Tesaro unit and AnaptysBio over licensing obligations and the use of Jemperli in combination therapies. Both sides have filed lawsuits and are seeking to tweak or terminate elements of the agreement, with a trial slated for July 2026. ^[39]

For now, this looks more like a contractual tug‑of‑war over economics than a threat to Jemperli’s availability, but it’s a reminder that partner‑heavy pipelines bring partner‑heavy disputes.

Analyst ratings and GSK stock forecasts for 2026

U.S. ADR (NYSE:GSK) – MarketBeat consensus: ^[40]

Rating:Hold (based on 8 analysts)
- 2 Sell, 4 Hold, 2 Buy
Average 12‑month target:$44.13
- High: $53.00
- Low: $35.25
- Implied move: about −8.8% from $48.40

Recent moves:

HSBC reiterated a Reduce (sell‑leaning) stance on 10 December 2025.
Bank of America upgraded GSK in late November from Underperform to Neutral.
Jefferies earlier boosted its stance to Buy with a $53 price target. ^[41]

London‑listed shares (LON:GSK) – MarketBeat instant alert: ^[42]

Consensus rating: Hold
Consensus price target:1,762p, modestly below the current ~1,800p level.
Per the same note, individual UK‑broker targets range roughly from 1,500p (J.P. Morgan “underweight”) to 2,100p (Jefferies “buy” and Shore Capital “buy”).

Outside the mainstream banks, some platforms are more bullish:

StockAnalysis.com, which tracks a smaller analyst universe, currently tags GSK as a “Strong Buy”, albeit based on just one analyst. ^[43]

Taken together, the sell‑side isn’t screaming “bargain” anymore after this year’s rally. The average forecast now assumes limited upside—or mild downside—over the next 12 months, with opinions split between those who see a still‑cheap cash‑cow and those worried about leverage, competition and pipeline execution risk.

Key risks GSK shareholders are watching

Even with most Zantac damage contained and guidance trending higher, several meaningful risks remain:

Regulatory and pricing pressure
- The U.S. Inflation Reduction Act (IRA) is already pressuring some branded‑drug prices, and GSK notes that Medicare Part D redesign is impacting products like Nucala and other respiratory drugs. ^[44]
- In the UK, although the new framework lowers rebate rates from 2026, the NHS will still exert significant leverage on prices, and the details of the post‑VPAG regime are not fully baked. ^[45]
Pipeline execution
- Blujepa (gonorrhoea) and depemokimab (asthma/CRSwNP) are live near‑term binary events. Regulatory delays or negative decisions in December would dent the growth narrative. ^[46]
- Longer‑term, key growth drivers like Arexvy, Blenrep, Nucala in COPD, momelotinib and later‑stage assets (e.g., depemokimab in COPD, oncology ADCs) must deliver against high expectations.
Competition and patent cliffs
- GSK’s HIV portfolio remains important for cash flow, but faces patent expiries later in the decade and intense competition from long‑acting injectables and generics—concerns repeatedly flagged in coverage of the CEO transition. ^[47]
- The company also has limited exposure to the booming obesity‑drug category, which is commanding large valuation multiples for peers.
Leverage and balance sheet flexibility
- With a debt‑to‑equity ratio above 100% and an acquisitive R&D strategy, GSK’s balance sheet is not as clean as some investors might like, even though cash generation is solid. ^[48]
Residual legal risk
- Zantac has moved from headline to footnote, but federal appeals and residual cases could, in worst‑case scenarios, lead to additional settlements. ^[49]
- Contract disputes like the Jemperli/AnaptysBio case underline that licensing conflicts can erode economics on key assets. ^[50]

Bottom line: how GSK stock looks as of 11 December 2025

Summing up the current picture:

Bullish elements

2025 is shaping up as a clean year of execution: upgraded guidance, strong Q3, growing specialty and vaccine franchises, and easing litigation. ^[51]
Valuation remains reasonable on classic metrics (mid‑teens trailing P/E, mid‑single‑digit sales growth, mid‑3% dividend yield, plus buybacks). ^[52]
The pipeline is delivering real approvals (Blujepa, Blenrep combo, Nucala COPD) with two more FDA decisions imminent. ^[53]
The $30bn U.S. investment plan and more accommodative UK pricing regime signal a clearer, if still politically noisy, operating environment. ^[54]

Bearish or caution flags

After a ~45–50% YTD run, some value investors are trimming positions, and the average analyst target now sits below the current share price on both sides of the Atlantic. ^[55]
Leverage is elevated, and GSK still has to prove it can turn its enlarged pipeline into sustained double‑digit earnings growth post‑2026. ^[56]
Litigation and policy risk aren’t gone—just less dramatic than they looked two years ago. ^[57]

For investors, GSK today looks less like the “cheap for a reason” laggard it once was and more like a mid‑growth, mid‑yield pharma name whose valuation has caught up with its story—but not necessarily outrun it. Whether that’s attractive depends on your view of:

December’s FDA calls on Blujepa and depemokimab,
The durability of demand for Arexvy, Shingrix, Nucala and Blenrep, and
How smoothly Luke Miels can steer GSK through the next wave of patent expiries and pricing reforms.