Updated: 17 December 2025
GSK plc stock (LSE: GSK; NYSE: GSK) is in focus on Dec. 17 after a major U.S. regulatory win: the FDA approved Exdensur (depemokimab‑ulaa) for severe asthma—giving GSK a new, ultra‑long‑acting biologic that’s dosed just twice a year. The approval lands as the company approaches a leadership handover on Jan. 1, 2026, and as investors weigh whether GSK’s late‑2025 pipeline momentum can translate into durable earnings growth in 2026 and beyond. [1]
Below is a full, news-driven breakdown of what’s moving GSK stock today, the most important recent catalysts, and how current analyst forecasts and technical indicators frame the setup into 2026.
The headline driver for GSK stock: FDA approves Exdensur for severe eosinophilic asthma
GSK announced that the U.S. Food and Drug Administration approved Exdensur (depemokimab‑ulaa) as an add‑on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in adults and pediatric patients 12 years and older. [2]
What makes this approval strategically important for GSK investors isn’t just the new label—it’s the dosing model. GSK positions Exdensur as an “ultra‑long‑acting biologic” designed for twice‑yearly dosing, a potential differentiator in a category where many biologics require monthly (or more frequent) dosing and ongoing adherence. [3]
The efficacy data investors are zeroing in on
In GSK’s stock‑exchange announcement, the company highlighted Phase III SWIFT‑1 and SWIFT‑2 results:
- 58% (SWIFT‑1) and 48% (SWIFT‑2) reductions in the rate of annualized asthma exacerbations versus placebo (both on standard of care).
- A pre‑specified pooled analysis showed a 72% reduction in clinically significant exacerbations requiring hospitalization and/or emergency department visits versus placebo. [4]
That combination—meaningful exacerbation reduction plus fewer injections—sets up the core commercial question for 2026: can convenience and outcomes expand the biologics‑eligible patient pool and win share from established rivals?
A key caveat: FDA declined a second indication (for now)
Reuters reported that the FDA did not approve Exdensur for chronic rhinosinusitis with nasal polyps (CRSwNP) at this time, even though the product has broader authorization in the UK. GSK said it remains in discussions with the FDA regarding the CRSwNP opportunity. [5]
This matters for valuation: investors tend to price a “platform” drug differently when it has multiple near‑term indications versus a single initial label.
Why Exdensur could matter financially (and what could hold it back)
From a stock perspective, Exdensur is being watched as a potential growth driver at a time when large pharma investors often worry about the “gravity” of patent expiries and competitive pressure across mature brands.
The bull case in one sentence
A twice‑yearly asthma biologic that reduces exacerbations and severe events could become a sticky, high‑value therapy—especially if it improves real‑world adherence and gets strong payer coverage.
GSK also frames the unmet need as large: its announcement cites an estimate that ~2 million Americans live with severe asthma, and that many still experience frequent exacerbations and hospitalizations despite available therapies. [6]
The real-world adoption question
The market is competitive. Reuters pointed to competition from biologics including Dupixent (Sanofi/Regeneron) and Xolair (Roche/Novartis), among others, noting that uptake will depend on how patients and clinicians value the twice‑yearly regimen. [7]
In other words: FDA approval removes regulatory risk for the asthma indication, but commercial execution risk now becomes the main variable investors will track through 2026 prescription trends and payer decisions.
Broader December catalysts: vaccines, antibiotics, oncology—and a pipeline drumbeat
Exdensur isn’t the only late‑year catalyst supporting sentiment around GSK stock. Several other items from the past week are feeding into the market’s “pipeline cadence” narrative.
1) Europe moves toward depemokimab approval
Earlier this month, Reuters reported the European Medicines Agency’s CHMP recommended approval for depemokimab for severe asthma (and CRSwNP) in Europe, with a European Commission decision expected in Q1 2026. [8]
That sets up an early‑2026 potential headline for GSK: EU approval would expand Exdensur’s commercial runway beyond the U.S. asthma label and could support broader multi‑indication positioning.
2) Arexvy: EU panel recommends expanded RSV vaccine use
GSK’s RSV vaccine Arexvy also got a supportive EU signal. Reuters reported an EMA panel recommended expanded use for all adults over 18, with GSK expecting final EU approval by February 2026. [9]
For GSK stock, this is relevant because RSV is a competitive vaccine market (with Pfizer and Moderna also active) and incremental addressable population can support revenue resilience—particularly important when investors compare vaccine durability versus specialty medicines growth.
3) Blujepa: FDA expands use for gonorrhea treatment in certain patients
Reuters reported the FDA expanded approval of GSK’s antibiotic Blujepa (gepotidacin) as an oral treatment for uncomplicated urogenital gonorrhea in patients 12 and older with limited or no alternative options. [10]
This is a portfolio story: GSK has been emphasizing infectious disease innovation, and antibiotic approvals tend to be viewed as strategically important even when early revenue expectations are more modest than blockbuster immunology drugs.
4) Oncology R&D: orphan drug designation for GSK’227 in small‑cell lung cancer
GSK also announced the FDA granted Orphan Drug Designation for GSK’227 (risvutatug rezetecan) in small‑cell lung cancer, citing early clinical data and the high unmet need in extensive‑stage disease. [11]
While this is not an immediate revenue driver like Exdensur, orphan designation can be a signal investors use to gauge pipeline optionality and regulatory momentum.
Capital returns: buybacks and dividends remain part of the GSK stock narrative
Even in a catalyst-heavy week, income and capital return still matter for how many long‑term holders value GSK stock—especially in the UK market.
Share buybacks
GSK continues to execute share repurchases. In a December 2025 Form 6‑K filing, the company disclosed it repurchased 230,000 shares on 12 December 2025, at prices between 1,816.00p and 1,837.00p, with a volume‑weighted average price of 1,827.59p (held as treasury shares). [12]
GSK has also communicated buyback planning at the programme level. A London Stock Exchange notice for the third tranche of its buyback programme stated purchases were expected to run from 30 September 2025 and be completed by 19 December 2025. [13]
Dividend visibility
In its Q3 2025 results announcement, GSK declared a 16p dividend for Q3 2025 and indicated 64p expected for full‑year 2025. [14]
Its dividend calendar also points to the next cash-flow milestones (including U.S. ADR details such as ex‑dividend timing and payment dates). [15]
GSK share price check: where the stock is trading on Dec. 17, 2025
Price context matters because it frames how much “good news” may already be priced in.
- U.S. ADR (NYSE: GSK): around $48.78 in recent trading data.
- London listing (LSE: GSK): recent data shows trading in the ~1,820p–1,830p area in mid‑December. [16]
From a momentum standpoint, the London Stock Exchange tear‑sheet indicated (as of its mid‑December report date) GSK was up roughly 36% year‑to‑date, and trading above key moving averages—evidence of a 2025 re‑rating that makes upcoming 2026 execution even more consequential. [17]
Analyst forecasts and price targets for GSK stock: mixed, clustered near the current price
Analyst views on GSK stock remain cautious‑to‑neutral overall, with targets often hovering near where the shares already trade—suggesting the market is waiting for more clarity on 2026 revenue mix, new‑product ramps, and margin trajectory.
Price targets (examples from major aggregators)
- MarketWatch’s analyst estimates for GSK show targets in a relatively tight band around the current trading range (median and average targets close to the stock price). [18]
- Investing.com’s compiled view shows a neutral stance overall, with a high target above current levels and a low target below, reflecting disagreement on upside versus execution risk. [19]
- Yahoo Finance’s forecast page similarly displays a spread of low‑to‑high targets with an overall mix of ratings. [20]
The important takeaway for investors is not the exact number—it’s that Exdensur’s launch curve (and any progress on the U.S. CRSwNP indication) could become the catalyst that pushes targets meaningfully higher if early adoption surprises to the upside.
Company guidance still anchors near-term expectations
At Q3, GSK upgraded 2025 guidance, and Reuters reported the company expected annual revenue growth of 6%–7% and core EPS growth of 10%–12%, noting its forecast incorporated enacted tariffs and modeled potential tariff impacts. [21]
That upgraded baseline is part of why the stock has shown strength in 2025—and also why 2026 will be judged against a higher bar.
Technical and market “read” on GSK stock: momentum has improved
Beyond fundamentals, some market participants pay attention to technical and quant-style signals.
- Investor’s Business Daily reported GSK’s composite rating rose to 96 (on Dec. 16), with the stock moving beyond a noted buy point and showing improving technical/fundamental characteristics versus peers. [22]
- The LSE tear‑sheet snapshot placed the stock above its 50‑day and 200‑day moving averages, and listed an RSI reading around the low‑60s range (often interpreted as strong but not extreme momentum). [23]
These aren’t guarantees, but they help explain why catalyst news like FDA approvals can have an outsized effect when a stock already has positive trend support.
The 2026 storyline investors are preparing for: leadership change plus “pipeline-to-P&L” execution
The other big piece of the GSK stock narrative is governance and strategy continuity.
GSK has confirmed that Luke Miels will assume full responsibilities as CEO and join the Board on 1 January 2026. [24]
In parallel, policy and investment signals have stayed in the headlines. The Guardian reported CEO Emma Walmsley emphasized the U.S. as a key investment destination and referenced a plan to invest $30 billion in the U.S. by 2030. [25]
For shareholders, the leadership transition is likely to sharpen focus on:
- Whether new launches (like Exdensur) can scale quickly enough to offset mature brand pressure,
- How GSK manages pricing, reimbursement, and policy uncertainty,
- And how efficiently the company converts R&D progress into operating leverage.
Risks to watch in GSK plc stock right now
No serious stock analysis is complete without the downside map. For GSK, the big watch‑items include:
- Commercial adoption risk for Exdensur
Twice‑yearly dosing is compelling, but payer coverage, physician behavior, and competition will decide whether Exdensur becomes a meaningful sales driver or a niche option. [26] - Label expansion uncertainty (CRSwNP in the U.S.)
The FDA’s current stance on CRSwNP creates uncertainty about timing and required data, even as the UK authorization covers that indication. [27] - Policy and pricing pressure
Large pharma remains exposed to evolving U.S. and UK policy debates around drug pricing and access. [28] - Legacy litigation overhang
GSK continues to publish updates regarding Zantac (ranitidine) litigation, which remains a reputational and financial risk category investors keep on the dashboard even when the pipeline is delivering good news. [29]
What to watch next for GSK stock
The next few checkpoints that could move GSK plc shares:
- Early 2026 EU decision on depemokimab/Exdensur (European Commission timeline referenced in reporting). [30]
- EU decision timing for expanded Arexvy use (GSK expects a decision by February 2026). [31]
- CEO transition on Jan. 1, 2026, which may come with refreshed priorities, updated KPIs, or sharper capital allocation signals. [32]
- More buyback execution disclosures as the third tranche approaches its stated completion window. [33]
References
1. www.reuters.com, 2. www.gsk.com, 3. www.gsk.com, 4. www.gsk.com, 5. www.reuters.com, 6. www.gsk.com, 7. www.reuters.com, 8. www.reuters.com, 9. www.reuters.com, 10. www.reuters.com, 11. www.gsk.com, 12. www.sec.gov, 13. www.londonstockexchange.com, 14. www.gsk.com, 15. www.gsk.com, 16. www.investing.com, 17. api.londonstockexchange.com, 18. www.marketwatch.com, 19. www.investing.com, 20. finance.yahoo.com, 21. www.reuters.com, 22. www.investors.com, 23. api.londonstockexchange.com, 24. www.gsk.com, 25. www.theguardian.com, 26. www.reuters.com, 27. www.reuters.com, 28. www.theguardian.com, 29. www.gsk.com, 30. www.reuters.com, 31. www.reuters.com, 32. www.gsk.com, 33. www.londonstockexchange.com
