GSK Stock News Today (Dec. 12, 2025): Arexvy EU Expansion, Blujepa FDA Approval, Analyst Forecasts and What’s Next

GSK Stock News Today (Dec. 12, 2025): Arexvy EU Expansion, Blujepa FDA Approval, Analyst Forecasts and What’s Next

Published: 12 December 2025

GSK plc stock is back in focus on Friday as investors digest a fast-moving cluster of regulatory headlines across vaccines, infectious diseases and oncology—alongside ongoing buybacks and fresh consensus forecasts that map out how GSK’s revenue mix may evolve into 2031.

On the New York Stock Exchange, GSK’s U.S.-listed ADR was trading around $48.88 in the latest available quote (prices move throughout the session).

Below is a full, publication-ready roundup of the latest GSK stock news and market-moving developments available as of 12.12.2025, plus analyst forecasts and the key catalysts investors are watching into early 2026.


What’s driving GSK stock on 12.12.2025

1) Arexvy gets positive CHMP opinion for adults 18+ in Europe

GSK said today that the European Medicines Agency’s CHMP has recommended expanding the label of its RSV vaccine Arexvy to all adults aged 18 years and older. GSK added that the European Commission’s final decision is expected in February 2026. [1]

Why this matters for the GSK share price:

  • Addressable market: A move from older/at‑risk cohorts toward “all adults 18+” meaningfully expands the eligible population in Europe—though real-world uptake will still depend on national immunisation guidance, reimbursement and seasonal demand.
  • Competitive landscape: GSK has been working to strengthen Arexvy’s position against rival RSV offerings from Pfizer and Moderna, and regulatory momentum in Europe is one lever in that competition. [2]
  • Timing clarity: Markets often react not only to the recommendation itself, but to the visibility on when a final decision could land (here, February 2026). [3]

What analysts think Arexvy could contribute:
In GSK’s own broker consensus file (as at 26/11/2025), analysts collectively modeled Arexvy sales of £542m in 2025, rising to £637m in 2026 and £1,174m by 2031 (core consensus, £m). [4]


2) FDA expands Blujepa (gepotidacin) for gonorrhea—first new class in decades

A second major catalyst arrived late Thursday: Reuters reported that the U.S. FDA expanded the use of GSK’s Blujepa (gepotidacin) as an oral treatment for uncomplicated urogenital gonorrhea in patients 12+ who have limited or no alternative options. Reuters also noted this is the first approval of a new antibiotic class for gonorrhea in decades, addressing rising resistance concerns. [5]

GSK’s own press release frames the approval as a new oral option in a setting where many patients rely on injectable therapy, highlighting the public health need for additional effective antibiotics. [6]

Why investors care:

  • Portfolio diversification: Reuters explicitly linked GSK’s push in infectious diseases (including RSV and new antibiotics) to the company’s effort to offset future pressure from HIV patent expirations. [7]
  • Commercial runway: Even if the initial label is narrower than “all-comers,” it establishes a foothold in an area with clear unmet need and potential for guideline-driven adoption.

What analysts forecast for Blujepa revenue:
GSK’s broker consensus (26/11/2025) shows a steep expected ramp: £14m in 2025, £105m in 2026, reaching £401m by 2031. [8]


3) Oncology pipeline momentum: FDA orphan designation for GSK’227 in small-cell lung cancer

Adding to the week’s positive tone for GSK’s pipeline, the company announced on 10 December 2025 that its B7‑H3–targeted antibody‑drug conjugate GSK’227 (risvutatug rezetecan) received U.S. FDA Orphan Drug Designation for small-cell lung cancer. [9]

This is not an approval—but orphan status can support development momentum via incentives and can elevate investor attention on pipeline value (especially as big pharma valuations increasingly reward credible oncology platforms).


Capital returns and share mechanics: buybacks, treasury shares, and a block listing

Ongoing £2bn buyback continues to reduce share count

GSK has been returning capital via a multi-tranche £2 billion buyback program (announced earlier in 2025). [10]

A regulatory filing tied to the program disclosed that GSK purchased 220,000 ordinary shares on 10 December 2025, to be held as treasury shares. [11]

Another filing summary indicated that since 30 September 2025, GSK had purchased 12,944,733 ordinary shares, and (at that point) held 238,409,577 ordinary shares in treasury, with 4,077,029,560 ordinary shares in issue excluding treasury shares. [12]

Why this matters for the stock: buybacks can support EPS and provide a steady bid, but the market will still prioritize the underlying growth outlook and execution.

Block listing: 250,000 new shares admitted to trading

Separately, GSK applied for admission of 250,000 ordinary shares under a block listing linked to the GlaxoSmithKline plc Share Save Plan 2022, with admission expected to become effective on 12 December 2025. [13]

This is relatively small against GSK’s multi‑billion share base, but it is part of the normal “share plan plumbing” investors often like to track alongside buybacks.


Analyst forecasts: what the consensus says about GSK through 2031

One of the most useful “single source of truth” snapshots available today is GSK’s own Analyst consensus page, which compiles broker estimates (from firms including Bank of America, Barclays, Deutsche Bank, Goldman Sachs, Jefferies, JP Morgan, Morgan Stanley, UBS and others) and notes the dataset is as at 26/11/2025. [14]

Headline revenue outlook (consensus)

The consensus shows total GSK turnover (core) of:

  • £32.5bn in 2025
  • £34.1bn in 2026
  • Rising to £36.3bn in 2029
  • Then easing to £34.8bn by 2031 [15]

Interpretation: Analysts appear to be modeling growth through the late 2020s, followed by a drag later—consistent with the widely discussed “patent cycle” dynamic in big pharma.

Mix shift: specialty grows; general medicines decline

Consensus forecasts show:

  • Specialty medicines rising from £13.3bn (2025) to £14.8bn (2026). [16]
  • General medicines drifting down over time (from £10.1bn in 2025 to £7.8bn in 2031). [17]
  • Vaccines edging upward (from £9.1bn in 2025 to £11.0bn in 2031). [18]

Product-level signals investors will focus on

The same consensus table highlights a few key narratives:

  • HIV franchise expected to decline: consensus shows HIV turnover £7.64bn (2025) falling to £4.49bn (2031). [19]
  • Oncology expected to expand materially: £1.97bn (2025) to £4.61bn (2031)—a central pillar of the “next GSK” equity story. [20]
  • Respiratory/Immunology/Inflammation rising from £3.73bn (2025) to £6.88bn (2031) in the consensus view. [21]

This helps explain why investors respond to pipeline and label-expansion headlines: they connect directly to the “mix shift” the Street is modeling.


Company guidance and long-term targets: where GSK differs from consensus

2025 outlook was upgraded after strong specialty medicine performance

In late October, Reuters reported GSK raised its 2025 forecast range, expecting annual revenue growth of 6% to 7% and core EPS growth of 10% to 12% (with prior ranges lower). [22]

GSK targets >£40bn revenue by 2031—consensus is lower

Earlier this year, Reuters reported that GSK raised its 2031 sales forecast to over £40 billion and announced a £2bn share buyback. [23]

But the broker consensus table on GSK’s site shows 2031 turnover at £34.8bn (as at 26/11/2025). [24]

What that gap means for the stock:
If investors gain confidence that pipeline execution (oncology, RI&I, vaccines, infectious diseases) can push closer to the company’s >£40bn ambition, that can support a higher valuation multiple. If not, the share price may behave more like a mature dividend/buyback story with limited rerating.


Leadership transition: another near-term focus point for GSK shares

GSK is approaching a major leadership handover. The Guardian reported in September that Emma Walmsley will step down as CEO at the end of 2025, with Luke Miels set to become CEO from 1 January 2026. [25]

For equity markets, CEO transitions can be catalysts for:

  • strategic refocusing (portfolio priorities, deal appetite),
  • changes in capital allocation,
  • shifts in risk tolerance around R&D and M&A.

Investors will likely listen closely for “tone” and execution detail on the Feb. 2026 full‑year results call.


Policy backdrop: UK and US headlines that could influence sentiment

Not all drivers are product-specific. The Guardian reported this week on the UK’s efforts to improve pharma competitiveness, including a reduction in the “clawback” rate on new medicine revenues paid to the NHS (from 22.5% to 14.5% in 2026), and it quoted Walmsley emphasizing the U.S. as the most attractive investment destination; the article also referenced a planned $30bn U.S. investment by 2030. [26]

Meanwhile, vaccine-policy volatility in the U.S. remains a theme across the sector. Reuters reported earlier this month that changes proposed by a U.S. advisory panel regarding hepatitis B vaccination policy drew concerns from vaccine makers including GSK, and the market reaction included a modest dip in GSK shares following the vote. [27]


Key dates to watch for GSK stock

Next earnings: Full-year & Q4 2025 results on 4 Feb 2026

GSK’s investor events calendar states it will announce full‑year and fourth quarter results on Wednesday, 4 February 2026. [28]

Dividend calendar checkpoints

GSK’s dividend calendar lists key Q4 2025 dividend milestones around the February 2026 reporting window (including an announcement date aligned with results). [29]

Regulatory: Europe’s final decision on expanded Arexvy use expected February 2026

GSK explicitly said the European Commission decision on the broadened Arexvy label is expected in February 2026. [30]


Bottom line for investors tracking GSK share price right now

As of 12.12.2025, the GSK stock narrative is being shaped by three overlapping forces:

  1. Regulatory momentum (Arexvy in Europe; Blujepa in the U.S.; oncology designations),
  2. Capital returns (ongoing buybacks with meaningful treasury accumulation),
  3. The medium-term mix shift (specialty/oncology/RI&I rising as HIV faces a forecast decline).

In the near term, the market is likely to trade GSK on: (a) incremental de‑risking events like label expansions and approvals, and (b) confidence that management can deliver the growth trajectory implied by its long-term ambitions—especially as the CEO transition approaches.

References

1. www.gsk.com, 2. www.reuters.com, 3. www.gsk.com, 4. www.gsk.com, 5. www.reuters.com, 6. www.gsk.com, 7. www.reuters.com, 8. www.gsk.com, 9. www.gsk.com, 10. www.reuters.com, 11. www.sec.gov, 12. www.streetinsider.com, 13. www.investegate.co.uk, 14. www.gsk.com, 15. www.gsk.com, 16. www.gsk.com, 17. www.gsk.com, 18. www.gsk.com, 19. www.gsk.com, 20. www.gsk.com, 21. www.gsk.com, 22. www.reuters.com, 23. www.reuters.com, 24. www.gsk.com, 25. www.theguardian.com, 26. www.theguardian.com, 27. www.reuters.com, 28. www.gsk.com, 29. www.gsk.com, 30. www.gsk.com

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