December 16, 2025 — GSK plc stock (LSE: GSK; NYSE: GSK) is firmly on investors’ radar today after a cluster of late-year regulatory catalysts across respiratory, vaccines, and infectious diseases — the kind of headline flow that can reshape sentiment around a large-cap biopharma even when quarterly earnings are weeks away.
In the latest available market data, GSK’s US-listed ADR (NYSE: GSK) traded around $49.24 (latest trade time in the feed: Dec. 16, 2025 00:15 UTC). Meanwhile, in London, GSK shares most recently closed at 1,833.50p on Dec. 15, up 0.49% on the day, with the Financial Times’ market data showing a ~+37.9% one-year change (data delayed intraday). [1]
What’s driving attention on 16.12.2025 is not one single announcement — it’s the convergence of multiple developments: a first-in-world approval for a twice-yearly asthma biologic, fresh European regulator support for both respiratory and RSV vaccine expansions, a US FDA infectious-disease milestone, and steady share repurchases that continue to shrink the equity base.
Below is a comprehensive, publication-ready breakdown of the latest GSK stock news, key catalysts, and investor forecasts as of today.
GSK stock price and recent performance: where shares stand
GSK’s London listing has been trading near multi-month highs, and the US ADR has also been hovering close to its recent range. Investing.com lists the ADR’s 52-week range at roughly $31.72 to $49.39, underlining how far the stock has rebounded from earlier lows. [2]
On the valuation side, FT market data (delayed) shows GSK at a mid-teens trailing P/E with a dividend yield in the mid-3% area (figures vary by data source and timing). [3]
The near-term question for many investors: can this late-2025 regulatory momentum translate into 2026 revenue acceleration — particularly in respiratory and vaccines, where competitive dynamics are intense and product differentiation matters.
Big catalyst for GSK shares: Exdensur (depemokimab) wins first global approval in the UK
The headline development is the UK authorization of Exdensur (depemokimab), which GSK describes as the first and only ultra-long-acting biologic with twice-yearly dosing to treat certain respiratory diseases. [4]
What was approved — and for whom?
GSK says the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Exdensur in two indications: [5]
- Add-on maintenance treatment for asthma with type 2 inflammation in adults and adolescents 12+ with an eosinophilic phenotype who remain inadequately controlled despite high standard-of-care inhaled therapies.
- Add-on therapy (with intranasal corticosteroids) for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults where systemic corticosteroids and/or surgery don’t provide adequate control.
The UK government announcement confirms the marketing authorisation was granted on 15 December 2025 to GSK, describing it as the first twice-yearly biological medicine approved in the UK for these conditions. [6]
Why investors care: the “twice-yearly” convenience angle
From a commercial standpoint, depemokimab’s core pitch is adherence and convenience: two doses a year rather than monthly or more frequent injections. GSK’s UK release highlights efficacy signals from its Phase III programs, including a pooled 54% reduction in clinically significant asthma exacerbations over 52 weeks and a 72% reduction in exacerbations requiring hospitalisation or emergency department visit in a secondary endpoint analysis (vs placebo, on standard of care). [7]
In plain market terms, a dosing schedule like that is designed to compete not only on clinical outcomes but also on real-world persistence — a factor that can materially influence biologic market share.
The next immediate catalyst: FDA decision expected by Dec. 16, 2025
Reuters reports that the UK approval is the first for Exdensur and notes the US FDA review is expected to conclude by December 16 — putting today firmly in the “binary catalyst” window. [8]
GSK also previously stated that depemokimab’s PDUFA date is 16 December 2025 (for asthma with type 2 inflammation and CRSwNP). [9]
Key implication for GSK stock today: even without a new FDA headline yet, traders often position ahead of PDUFA dates — and volatility can rise in both directions around any decision, label language, or post-decision commercial commentary.
Europe tailwinds: positive CHMP opinions for depemokimab, Arexvy expansion, and Nucala COPD
GSK has also stacked up supportive European regulatory milestones in December, adding to the sense that the company is entering 2026 with meaningful “pipeline-to-market” momentum.
Depemokimab: EU committee recommends approval
On Dec. 12, Reuters reported that the European Medicines Agency’s CHMP issued a positive opinion recommending approval of depemokimab for severe asthma with type 2 inflammation and CRSwNP. [10]
Reuters also contextualized the competitive landscape, naming rival biologics such as Dupixent (Sanofi/Regeneron), Xolair (Roche/Novartis), and Tezspire (Amgen/AstraZeneca) — a reminder that even strong regulatory news must ultimately compete in crowded specialty markets. [11]
Arexvy (RSV vaccine): CHMP backs broader adult use
In a separate December development, GSK announced the CHMP recommended expanding Arexvy to all adults aged 18+, with the European Commission’s final decision expected in February 2026. [12]
Reuters likewise noted the potential for the expanded adult indication to intensify competition in RSV vaccines versus Pfizer’s Abrysvo and Moderna’s entrant. [13]
Why it matters for GSK shares: RSV remains a strategically important vaccine franchise, and label breadth in Europe can influence both volume opportunity and seasonal revenue visibility.
Nucala: positive CHMP opinion for COPD indication
GSK also reported that Nucala (mepolizumab) received a positive CHMP opinion for COPD (in adults with a raised blood eosinophil count, as add-on maintenance to inhaled triple therapy). [14]
GSK’s release adds useful context for investors: Nucala was approved in the US for COPD in May 2025, and Europe already includes multiple indications for the drug. [15]
Taken together, these respiratory updates (depemokimab + Nucala) reinforce a broader GSK thesis: respiratory, immunology and inflammation is one of the company’s key growth engines, and December’s regulatory news flow supports that narrative heading into 2026.
US milestone: FDA expands Blujepa (gepotidacin) for gonorrhea — a new antibiotic class
Beyond respiratory and vaccines, GSK also delivered a notable infectious-disease headline.
GSK announced that the US FDA approved a supplemental New Drug Application for gepotidacin (brand: Blujepa) as an oral option for uncomplicated urogenital gonorrhea in adults and pediatric patients aged 12+ (with certain use limitations). [16]
The company highlighted two points that are especially relevant for both public-health framing and investor narratives:
- It is positioned as the first in a new antibiotic class for gonorrhea approved in over three decades. [17]
- Gonorrhea treatment in the US has largely relied on injectable options, making an oral alternative potentially meaningful for real-world uptake. [18]
Reuters also covered the approval, emphasizing it as a noteworthy FDA decision for GSK in December’s regulatory calendar. [19]
Oncology pipeline signal: FDA Orphan Drug Designation for GSK’227 (risvutatug rezetecan) in SCLC
While near-term revenue catalysts tend to dominate stock reaction, longer-cycle pipeline progress can matter for valuation — especially in oncology, where investors may assign meaningful option value to differentiated assets.
On Dec. 10, GSK announced its B7-H3–targeted antibody-drug conjugate (ADC) GSK’227, now referred to as risvutatug rezetecan, received Orphan Drug Designation from the US FDA for small-cell lung cancer (SCLC). [20]
GSK said the designation was supported by early clinical data showing durable responses in certain extensive-stage SCLC patients (ARTEMIS-001), and noted it had begun a global Phase III trial in relapsed extensive-stage SCLC in August 2025. [21]
For GSK stock watchers, this is part of the broader question: how much can oncology contribute to the next multi-year growth leg, and when might that contribution become visible in reported sales.
Capital return backdrop: GSK share buybacks continue
Alongside product news, GSK’s capital return program remains a steady drumbeat supporting investor attention.
A recent transaction notice (filed via SEC materials and also disseminated through market announcement channels) states GSK repurchased 230,000 ordinary shares on 12 December 2025, at a volume-weighted average price of 1,827.59p, and that since 30 September 2025 the company had repurchased 13,391,733 shares under the program. [22]
The same disclosure reports that after the purchase the company held 238,856,577 shares in treasury and had 4,076,584,506 voting shares in issue (treasury shares representing about 5.86% of voting rights). [23]
Why it matters for the stock: buybacks can provide incremental EPS support over time and are often read as a management signal about confidence in cash generation — though they do not remove fundamental R&D and competitive risks.
GSK forecasts: what analysts expect for revenue, EPS, dividends, and cash flow
For investors looking past the day-to-day headlines, GSK’s company-compiled analyst consensus (core income statement and product revenue figures as at 26/11/2025) provides one of the clearest snapshots of market expectations heading into 2026. [24]
Sales outlook: modest growth expected into 2026, then a longer-cycle arc
According to the consensus table on GSK’s investor site, analysts expect: [25]
- Total turnover (GSK): £32,515m (2025) → £34,100m (2026)
- Specialty medicines: £13,338m (2025) → £14,795m (2026)
- Vaccines: £9,063m (2025) → £9,285m (2026)
- General medicines: £10,113m (2025) → £10,021m (2026)
The mix implied by these numbers is important: Specialty is expected to lead growth, while general medicines are modeled as gradually declining — a pattern consistent with mature primary-care franchises and generic pressure.
Earnings and shareholder returns: consensus points to rising EPS and dividends
The same analyst consensus expects (core measures): [26]
- Earnings per share:170.1p (2025) → 184.1p (2026)
- Dividend per share:63.6p (2025) → 66.2p (2026)
It also models free cash flow expanding meaningfully: £3,351m (2025) → £5,831m (2026), while net debt is expected to trend down over time (consensus shows £14,232m in 2025 and £11,254m in 2026, then lower in later years). [27]
Product-level expectations: what the Street is modeling for key franchises
GSK’s published consensus includes product revenue lines that are useful “reality checks” for narrative-driven headlines: [28]
- Shingrix: £3,401m (2025) → £3,473m (2026)
- Arexvy: £542m (2025) → £637m (2026)
- Trelegy: £2,973m (2025) → £3,117m (2026)
- Dovato: £2,659m (2025) → £2,941m (2026)
- Cabenuva: £1,395m (2025) → £1,689m (2026)
- Blujepa (gepotidacin): £14m (2025) → £105m (2026)
From an “analysis” standpoint, the message is clear: while vaccines like Arexvy can be meaningful, the consensus still points to large respiratory/HIV anchors (Trelegy, Dovato/Cabenuva regimens) carrying much of the near-term revenue base — with newer launches (like Blujepa) modeled as ramping.
What to watch next for GSK stock: the near-term catalyst calendar
As of 16.12.2025, several high-visibility milestones sit close together:
- US FDA decision due for depemokimab (PDUFA date Dec. 16, per GSK) — a potential near-term volatility driver. [29]
- European Commission decisions:
- Commercial follow-through: how quickly new labels translate to formulary access, prescriber adoption, and demand — especially in respiratory biologics where competition is intense. [32]
Policy and macro context: why geography still matters for GSK valuation
GSK’s leadership has been explicit that the US remains central to pharma investment decisions. The Guardian reported comments from CEO Emma Walmsley arguing the US is the most attractive place for drug companies to invest, and referenced GSK’s plan to invest $30 billion in the US by 2030. [33]
Reuters has also previously reported on GSK committing $30 billion to US R&D and manufacturing expansion (including a new factory for cancer medicines), underscoring the company’s strategic tilt toward the US market. [34]
For stock analysis, this matters because investors often view:
- US commercial scale as the biggest prize, especially for specialty medicines,
- while regulatory and reimbursement environments (UK/EU/US) can influence launch trajectories and margin durability.
Bottom line: why GSK stock is in the spotlight on 16.12.2025
GSK plc shares are being pulled into focus by a rare alignment of near-term regulatory catalysts and longer-cycle pipeline signals:
- Exdensur (depemokimab) has a first global approval in the UK, with the FDA decision due today — a catalyst that can drive headline volatility and reshape respiratory growth expectations. [35]
- Europe is adding momentum through CHMP support for depemokimab, Nucala in COPD, and broader adult use of Arexvy (decision expected Feb. 2026). [36]
- The US FDA expanded Blujepa (gepotidacin) into gonorrhea, reinforcing GSK’s infectious-disease positioning with a noteworthy “new antibiotic class” narrative. [37]
- Ongoing buybacks continue to support shareholder returns alongside the operating story. [38]
- Analyst consensus (as compiled by GSK) still frames the core debate: steady top-line growth, rising EPS, and improving cash flow — with specialty medicines expected to remain the primary growth engine. [39]
References
1. markets.ft.com, 2. www.investing.com, 3. markets.ft.com, 4. www.gsk.com, 5. www.gsk.com, 6. www.gov.uk, 7. www.gsk.com, 8. www.reuters.com, 9. www.gsk.com, 10. www.reuters.com, 11. www.reuters.com, 12. www.gsk.com, 13. www.reuters.com, 14. www.ema.europa.eu, 15. www.gsk.com, 16. www.gsk.com, 17. www.gsk.com, 18. www.gsk.com, 19. www.reuters.com, 20. www.gsk.com, 21. www.gsk.com, 22. www.sec.gov, 23. www.sec.gov, 24. www.gsk.com, 25. www.gsk.com, 26. www.gsk.com, 27. www.gsk.com, 28. www.gsk.com, 29. www.gsk.com, 30. www.reuters.com, 31. www.gsk.com, 32. www.reuters.com, 33. www.theguardian.com, 34. www.reuters.com, 35. www.gsk.com, 36. www.reuters.com, 37. www.gsk.com, 38. www.sec.gov, 39. www.gsk.com
