GSK plc Stock News & Forecasts (Dec. 15, 2025): FDA Catalyst for Depemokimab, EU Backs Nucala and Arexvy, Analysts Map the Path Ahead
GSK plc stock (LSE: GSK, NYSE: GSK) is ending 2025 with a rare “cluster” of market-moving catalysts packed into the same two-week window: fresh U.S. regulatory momentum for a new antibiotic, European regulatory backing for multiple respiratory products, and an imminent FDA decision that could reshape GSK’s long-term outlook in severe asthma and nasal polyps.
For investors, this isn’t just headline noise. It’s the kind of sequencing—approval decisions, label expansions, and portfolio reinforcement—that can change how analysts model revenue durability, how shareholders think about valuation multiples, and how the market prices “pipeline confidence” versus “patent-cliff anxiety.”
Below is a comprehensive, publication-ready roundup of the most relevant GSK stock news, forecasts, and professional analysis as of December 15, 2025, with the key dates and what they could mean for the share price next.
GSK stock price check (U.S. ADR and London shares)
- GSK ADR (NYSE: GSK) last traded at $48.81, with the most recent recorded trade time showing Saturday, Dec. 13 (UTC)—reflecting the latest available U.S. market data after Friday’s close.
- GSK ordinary shares (LSE: GSK) were shown with an open price around 1,816.50p and a previous close of 1,824.50p (Dec. 12, 2025) on the London Stock Exchange feed. [1]
Because the ADR and London line track the same underlying business (with currency and market-hours differences), the “real story” for December 15 is less about a single tick and more about what the next 24–72 hours could unlock—particularly on the U.S. regulatory calendar.
The big near-term catalyst: FDA decision for depemokimab is due Dec. 16
On December 15, 2025, BioSpace flagged that the FDA has back-to-back decisions due on Dec. 16 for depemokimab, GSK’s ultra-long-acting anti‑IL‑5 antibody, being evaluated for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). [2]
Why markets care: depemokimab is designed around an unusually investor-friendly concept—twice-yearly dosing—which, if broadly adopted, can support strong persistence and predictable revenue streams in chronic inflammatory disease categories where adherence often falls apart.
Just days earlier, Reuters reported that Europe’s CHMP (the EMA’s Committee for Medicinal Products for Human Use) recommended approval of depemokimab for severe asthma with type 2 inflammation and CRSwNP, with a European Commission decision expected in early 2026. [3]
GSK’s own press release emphasized the same positioning: depemokimab could become the first and only ultra‑long‑acting biologic in the EU for these respiratory indications if approved. [4]
Investor takeaway (Dec 15 framing): The market is staring at a classic “two-step”:
- FDA decision (Dec. 16) → immediate sentiment impact and potentially faster commercialization momentum. [5]
- European Commission decision (Q1 2026 expected) → scale potential across major EU markets, reinforcing longer-term consensus models. [6]
Europe also backed Nucala for COPD—a meaningful respiratory expansion
GSK isn’t betting everything on one new biologic. Another respiratory headline landed the same week: Nucala (mepolizumab) received a positive CHMP opinion recommending approval for uncontrolled COPD characterized by raised eosinophils, as an add-on to inhaled triple therapy (ICS/LABA/LAMA). [7]
This matters because COPD is a large, high-burden category. Even a targeted eosinophilic subset can translate into meaningful sales, especially if payer access and guideline positioning cooperate.
GSK’s statement notes this CHMP step is based on Phase III evidence and would expand Nucala’s footprint if the European Commission follows through in Q1 2026. [8]
Market implication: Depemokimab is the shiny “new-new.” Nucala is the “already-selling asset” that could widen its addressable market. Together, they reinforce the idea that GSK’s respiratory franchise is trying to become a multi-product platform rather than a single-product story.
Arexvy: EU regulator backing points to broader RSV vaccine reach
GSK’s RSV vaccine Arexvy remains a key investor focus because RSV is both commercially meaningful and politically/competitively complicated.
Reuters reported that an EMA panel recommended expanded use of Arexvy for all adults aged 18+, with GSK expecting final EU approval for the broader indication by February 2026. [9]
If that expansion is finalized, it widens the eligible population and positions Arexvy more directly against competitors including Pfizer and Moderna in the RSV category. [10]
What investors watch next: regulatory is only step one. The “real” stock-driving question becomes demand durability, seasonal uptake, and how competitive dynamics affect pricing and market share.
Blujepa gets FDA expansion for gonorrhea—infectious disease momentum (and a rare antibiotic win)
Another major U.S. headline that still matters on Dec. 15: Reuters reported the FDA expanded approval for GSK’s antibiotic Blujepa (gepotidacin) as an oral treatment for uncomplicated urogenital gonorrhea in certain patients aged 12+ with limited or no alternative options. [11]
The FDA also issued a public statement highlighting the approvals of two oral therapies for gonorrhea, noting that Blujepa was approved “yesterday” relative to its announcement, reinforcing the timing and regulatory significance. [12]
GSK’s press release positioned Blujepa as the first in a new antibiotic class for gonorrhea approved in more than three decades, underscoring how unusual it is to see genuinely novel antibiotic classes reach market in this space. [13]
Reuters also framed the strategic “why now”: strengthening the infectious disease portfolio as GSK faces upcoming patent expirations on key HIV medicines—a reminder that the market constantly weighs fresh launches against lifecycle pressure. [14]
Capital return and “share technicals”: buyback activity continues into the Dec. 19 tranche finish
Beyond products and regulators, GSK has continued to execute on shareholder returns via buybacks.
- GSK’s third tranche of its broader buyback program is up to £0.3 billion, expected to run from Sept. 30, 2025 through Dec. 19, 2025, per the London Stock Exchange announcement. [15]
- A separate “transaction in own shares” announcement details ongoing repurchases executed through BNP Paribas, reflecting routine program execution rather than a one-off event. [16]
Why this matters for the stock: Buybacks don’t guarantee upside, but they can provide mechanical support (reduced share count, incremental EPS lift) and signal management confidence in cash generation—especially when paired with guidance upgrades.
Analyst consensus forecasts: what the Street models for revenue, EPS, dividend, and key products
One of the most useful “forecast snapshots” for GSK stock right now comes from GSK’s own published analyst consensus, which compiles estimates from major covering firms and, importantly, provides a transparent timestamp: core income statement and product revenue figures as at 26/11/2025. [17]
Top-line and earnings outlook (consensus snapshot)
Analysts’ mean estimates (per GSK’s compiled consensus) model:
- 2025 turnover:£32,515m (~£32.5bn)
- 2026 turnover:£34,100m (~£34.1bn)
- 2025 EPS:170.1p
- 2026 EPS:184.1p
- 2025 dividend per share:63.6p
- 2026 dividend per share:66.2p [18]
Consensus also projects improving free cash flow and a declining net debt trajectory over time—part of the “quality pharma” narrative investors tend to reward when pipeline execution cooperates. [19]
Product-level modeling: where analysts expect growth to come from
This is where the current news flow and the forecast models collide:
- Arexvy is modeled at £542m (2025) rising to £637m (2026) in the consensus table—important context as the EU considers broader adult use. [20]
- Depemokimab appears in the consensus product table with £193m (2026) and then ramps in subsequent years—exactly why the FDA/EMA decisions are treated as stock catalysts rather than academic milestones. [21]
- Nucala remains a large base business in consensus modeling (£1,988m in 2025; £2,144m in 2026), making COPD expansion news more than just “nice to have.” [22]
- Blujepa (gepotidacin) is modeled as a small number in 2025 (£14m) with higher numbers in later years—reflecting a ramp story rather than an overnight blockbuster. [23]
Is GSK stock a Buy, Hold, or Sell right now? Here’s what consensus targets suggest
Different platforms aggregate analyst calls differently, but the directional message is consistent: neutral-to-mixed, with valuation debates often tied to pipeline confidence and execution.
- MarketWatch (ADR) shows an average recommendation: Hold and an average target price around $48.53 (with 7 ratings listed). [24]
- Investing.com (London line) reports a “Neutral” consensus view from 18 analysts, with an average 12‑month target around 1,863.6p, and a wide high/low range—highlighting uncertainty dispersion rather than a single clean narrative. [25]
How to interpret this (without hype): When targets cluster near the current price, the market is basically saying, “Show me the next proof point.” For GSK in mid‑December 2025, that proof point is heavily linked to depemokimab’s FDA outcome and how the respiratory/vaccine portfolio translates regulatory wins into real prescriptions and tender wins.
GSK’s dividend timeline: Dec. 15 is a key date for DRIP elections
December 15, 2025 is not just a “pipeline news” day. It also matters for income investors.
GSK’s official dividend calendar lists Dec. 15, 2025 as the last date for DRIP elections for the Q3 2025 dividend, with the payment date set for Jan. 8, 2026. [26]
For dividend-focused shareholders, that’s an immediate calendar item—especially for those using dividend reinvestment plans to compound positions.
Next corporate calendar milestones: full-year results are set for Feb. 4, 2026
GSK’s investor events calendar states the company will announce full year and fourth quarter results on Wednesday, February 4, 2026. [27]
That date matters because December regulatory news can influence how investors position ahead of February reporting—particularly if approvals/label expansions change the confidence level around 2026 launch trajectories.
Policy and macro backdrop: investment signals from GSK leadership
GSK’s share price doesn’t trade in a vacuum; it trades in a world where policy can change commercial math.
In UK business coverage, GSK CEO Emma Walmsley argued the U.S. remains the best place for drug company investment, while also pointing to China as a key market. The same reporting highlighted GSK’s plan to invest $30 billion in the U.S. by 2030, and discussed UK policy changes affecting life sciences economics (including NHS-related rebate/clawback adjustments and NICE threshold moves). [28]
For GSK stock, this is the “soft power” side of the thesis: where future plants, trials, and launches get prioritized—and where margins may be most defendable.
What to watch next: the near-term decision tree for GSK stock
As of Dec. 15, 2025, here are the events most likely to shape GSK’s next move:
- Dec. 16, 2025 (FDA): depemokimab decisions for severe asthma and CRSwNP—potentially a major sentiment swing. [29]
- Q1 2026 (EU Commission): expected decisions following CHMP opinions for depemokimab and Nucala in COPD. [30]
- By Feb. 2026 (EU): potential final approval timing for broader Arexvy adult use, per GSK expectations cited by Reuters. [31]
- Feb. 4, 2026: GSK full-year results—an opportunity to quantify momentum and update guidance. [32]
Bottom line for Dec. 15, 2025
GSK plc stock is in a catalyst-rich stretch where the usual slow-and-steady pharma narrative gets replaced (briefly) by something closer to a high-stakes checklist:
Analysts’ forward models (including product-level revenue ramps) show why these approvals matter: they are directly embedded in how the Street projects 2026–2031 growth. [33]GSK plc stock (LSE: GSK, NYSE: GSK) is ending 2025 with a rare “cluster” of market-moving catalysts packed into the same two-week window: fresh U.S. regulatory momentum for a new antibiotic, European regulatory backing for multiple respiratory products, and an imminent FDA decision that could reshape GSK’s long-term outlook in severe asthma and nasal polyps.
Regulators are leaning positive in Europe on multiple respiratory assets (depemokimab and Nucala), while Arexvy’s addressable population could widen. [34]
The U.S. has already delivered a meaningful infectious disease win via Blujepa’s expanded gonorrhea indication, reinforcing GSK’s portfolio-building ahead of known lifecycle pressures. [35]
The market’s next “yes/no” moment arrives immediately with depemokimab’s FDA decision due Dec. 16, which could influence both near-term trading and longer-term valuation framing. [36]
For investors, this isn’t just headline noise. It’s the kind of sequencing—approval decisions, label expansions, and portfolio reinforcement—that can change how analysts model revenue durability, how shareholders think about valuation multiples, and how the market prices “pipeline confidence” versus “patent-cliff anxiety.”
Below is a comprehensive, publication-ready roundup of the most relevant GSK stock news, forecasts, and professional analysis as of December 15, 2025, with the key dates and what they could mean for the share price next.
GSK stock price check (U.S. ADR and London shares)
- GSK ADR (NYSE: GSK) last traded at $48.81, with the most recent recorded trade time showing Saturday, Dec. 13 (UTC)—reflecting the latest available U.S. market data after Friday’s close.
- GSK ordinary shares (LSE: GSK) were shown with an open price around 1,816.50p and a previous close of 1,824.50p (Dec. 12, 2025) on the London Stock Exchange feed. [37]
Because the ADR and London line track the same underlying business (with currency and market-hours differences), the “real story” for December 15 is less about a single tick and more about what the next 24–72 hours could unlock—particularly on the U.S. regulatory calendar.
The big near-term catalyst: FDA decision for depemokimab is due Dec. 16
On December 15, 2025, BioSpace flagged that the FDA has back-to-back decisions due on Dec. 16 for depemokimab, GSK’s ultra-long-acting anti‑IL‑5 antibody, being evaluated for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). [38]
Why markets care: depemokimab is designed around an unusually investor-friendly concept—twice-yearly dosing—which, if broadly adopted, can support strong persistence and predictable revenue streams in chronic inflammatory disease categories where adherence often falls apart.
Just days earlier, Reuters reported that Europe’s CHMP (the EMA’s Committee for Medicinal Products for Human Use) recommended approval of depemokimab for severe asthma with type 2 inflammation and CRSwNP, with a European Commission decision expected in early 2026. [39]
GSK’s own press release emphasized the same positioning: depemokimab could become the first and only ultra‑long‑acting biologic in the EU for these respiratory indications if approved. [40]
Investor takeaway (Dec 15 framing): The market is staring at a classic “two-step”:
- FDA decision (Dec. 16) → immediate sentiment impact and potentially faster commercialization momentum. [41]
- European Commission decision (Q1 2026 expected) → scale potential across major EU markets, reinforcing longer-term consensus models. [42]
Europe also backed Nucala for COPD—a meaningful respiratory expansion
GSK isn’t betting everything on one new biologic. Another respiratory headline landed the same week: Nucala (mepolizumab) received a positive CHMP opinion recommending approval for uncontrolled COPD characterized by raised eosinophils, as an add-on to inhaled triple therapy (ICS/LABA/LAMA). [43]
This matters because COPD is a large, high-burden category. Even a targeted eosinophilic subset can translate into meaningful sales, especially if payer access and guideline positioning cooperate.
GSK’s statement notes this CHMP step is based on Phase III evidence and would expand Nucala’s footprint if the European Commission follows through in Q1 2026. [44]
Market implication: Depemokimab is the shiny “new-new.” Nucala is the “already-selling asset” that could widen its addressable market. Together, they reinforce the idea that GSK’s respiratory franchise is trying to become a multi-product platform rather than a single-product story.
Arexvy: EU regulator backing points to broader RSV vaccine reach
GSK’s RSV vaccine Arexvy remains a key investor focus because RSV is both commercially meaningful and politically/competitively complicated.
Reuters reported that an EMA panel recommended expanded use of Arexvy for all adults aged 18+, with GSK expecting final EU approval for the broader indication by February 2026. [45]
If that expansion is finalized, it widens the eligible population and positions Arexvy more directly against competitors including Pfizer and Moderna in the RSV category. [46]
What investors watch next: regulatory is only step one. The “real” stock-driving question becomes demand durability, seasonal uptake, and how competitive dynamics affect pricing and market share.
Blujepa gets FDA expansion for gonorrhea—infectious disease momentum (and a rare antibiotic win)
Another major U.S. headline that still matters on Dec. 15: Reuters reported the FDA expanded approval for GSK’s antibiotic Blujepa (gepotidacin) as an oral treatment for uncomplicated urogenital gonorrhea in certain patients aged 12+ with limited or no alternative options. [47]
The FDA also issued a public statement highlighting the approvals of two oral therapies for gonorrhea, noting that Blujepa was approved “yesterday” relative to its announcement, reinforcing the timing and regulatory significance. [48]
GSK’s press release positioned Blujepa as the first in a new antibiotic class for gonorrhea approved in more than three decades, underscoring how unusual it is to see genuinely novel antibiotic classes reach market in this space. [49]
Reuters also framed the strategic “why now”: strengthening the infectious disease portfolio as GSK faces upcoming patent expirations on key HIV medicines—a reminder that the market constantly weighs fresh launches against lifecycle pressure. [50]
Capital return and “share technicals”: buyback activity continues into the Dec. 19 tranche finish
Beyond products and regulators, GSK has continued to execute on shareholder returns via buybacks.
- GSK’s third tranche of its broader buyback program is up to £0.3 billion, expected to run from Sept. 30, 2025 through Dec. 19, 2025, per the London Stock Exchange announcement. [51]
- A separate “transaction in own shares” announcement details ongoing repurchases executed through BNP Paribas, reflecting routine program execution rather than a one-off event. [52]
Why this matters for the stock: Buybacks don’t guarantee upside, but they can provide mechanical support (reduced share count, incremental EPS lift) and signal management confidence in cash generation—especially when paired with guidance upgrades.
Analyst consensus forecasts: what the Street models for revenue, EPS, dividend, and key products
One of the most useful “forecast snapshots” for GSK stock right now comes from GSK’s own published analyst consensus, which compiles estimates from major covering firms and, importantly, provides a transparent timestamp: core income statement and product revenue figures as at 26/11/2025. [53]
Top-line and earnings outlook (consensus snapshot)
Analysts’ mean estimates (per GSK’s compiled consensus) model:
- 2025 turnover:£32,515m (~£32.5bn)
- 2026 turnover:£34,100m (~£34.1bn)
- 2025 EPS:170.1p
- 2026 EPS:184.1p
- 2025 dividend per share:63.6p
- 2026 dividend per share:66.2p [54]
Consensus also projects improving free cash flow and a declining net debt trajectory over time—part of the “quality pharma” narrative investors tend to reward when pipeline execution cooperates. [55]
Product-level modeling: where analysts expect growth to come from
This is where the current news flow and the forecast models collide:
- Arexvy is modeled at £542m (2025) rising to £637m (2026) in the consensus table—important context as the EU considers broader adult use. [56]
- Depemokimab appears in the consensus product table with £193m (2026) and then ramps in subsequent years—exactly why the FDA/EMA decisions are treated as stock catalysts rather than academic milestones. [57]
- Nucala remains a large base business in consensus modeling (£1,988m in 2025; £2,144m in 2026), making COPD expansion news more than just “nice to have.” [58]
- Blujepa (gepotidacin) is modeled as a small number in 2025 (£14m) with higher numbers in later years—reflecting a ramp story rather than an overnight blockbuster. [59]
Is GSK stock a Buy, Hold, or Sell right now? Here’s what consensus targets suggest
Different platforms aggregate analyst calls differently, but the directional message is consistent: neutral-to-mixed, with valuation debates often tied to pipeline confidence and execution.
- MarketWatch (ADR) shows an average recommendation: Hold and an average target price around $48.53 (with 7 ratings listed). [60]
- Investing.com (London line) reports a “Neutral” consensus view from 18 analysts, with an average 12‑month target around 1,863.6p, and a wide high/low range—highlighting uncertainty dispersion rather than a single clean narrative. [61]
How to interpret this (without hype): When targets cluster near the current price, the market is basically saying, “Show me the next proof point.” For GSK in mid‑December 2025, that proof point is heavily linked to depemokimab’s FDA outcome and how the respiratory/vaccine portfolio translates regulatory wins into real prescriptions and tender wins.
GSK’s dividend timeline: Dec. 15 is a key date for DRIP elections
December 15, 2025 is not just a “pipeline news” day. It also matters for income investors.
GSK’s official dividend calendar lists Dec. 15, 2025 as the last date for DRIP elections for the Q3 2025 dividend, with the payment date set for Jan. 8, 2026. [62]
For dividend-focused shareholders, that’s an immediate calendar item—especially for those using dividend reinvestment plans to compound positions.
Next corporate calendar milestones: full-year results are set for Feb. 4, 2026
GSK’s investor events calendar states the company will announce full year and fourth quarter results on Wednesday, February 4, 2026. [63]
That date matters because December regulatory news can influence how investors position ahead of February reporting—particularly if approvals/label expansions change the confidence level around 2026 launch trajectories.
Policy and macro backdrop: investment signals from GSK leadership
GSK’s share price doesn’t trade in a vacuum; it trades in a world where policy can change commercial math.
In UK business coverage, GSK CEO Emma Walmsley argued the U.S. remains the best place for drug company investment, while also pointing to China as a key market. The same reporting highlighted GSK’s plan to invest $30 billion in the U.S. by 2030, and discussed UK policy changes affecting life sciences economics (including NHS-related rebate/clawback adjustments and NICE threshold moves). [64]
For GSK stock, this is the “soft power” side of the thesis: where future plants, trials, and launches get prioritized—and where margins may be most defendable.
What to watch next: the near-term decision tree for GSK stock
As of Dec. 15, 2025, here are the events most likely to shape GSK’s next move:
- Dec. 16, 2025 (FDA): depemokimab decisions for severe asthma and CRSwNP—potentially a major sentiment swing. [65]
- Q1 2026 (EU Commission): expected decisions following CHMP opinions for depemokimab and Nucala in COPD. [66]
- By Feb. 2026 (EU): potential final approval timing for broader Arexvy adult use, per GSK expectations cited by Reuters. [67]
- Feb. 4, 2026: GSK full-year results—an opportunity to quantify momentum and update guidance. [68]
Bottom line for Dec. 15, 2025
GSK plc stock is in a catalyst-rich stretch where the usual slow-and-steady pharma narrative gets replaced (briefly) by something closer to a high-stakes checklist:
- Regulators are leaning positive in Europe on multiple respiratory assets (depemokimab and Nucala), while Arexvy’s addressable population could widen. [69]
- The U.S. has already delivered a meaningful infectious disease win via Blujepa’s expanded gonorrhea indication, reinforcing GSK’s portfolio-building ahead of known lifecycle pressures. [70]
- The market’s next “yes/no” moment arrives immediately with depemokimab’s FDA decision due Dec. 16, which could influence both near-term trading and longer-term valuation framing. [71]
- Analysts’ forward models (including product-level revenue ramps) show why these approvals matter: they are directly embedded in how the Street projects 2026–2031 growth. [72]
References
1. www.londonstockexchange.com, 2. www.biospace.com, 3. www.reuters.com, 4. www.gsk.com, 5. www.biospace.com, 6. www.reuters.com, 7. www.gsk.com, 8. www.gsk.com, 9. www.reuters.com, 10. www.reuters.com, 11. www.reuters.com, 12. www.fda.gov, 13. www.gsk.com, 14. www.reuters.com, 15. www.londonstockexchange.com, 16. www.londonstockexchange.com, 17. www.gsk.com, 18. www.gsk.com, 19. www.gsk.com, 20. www.gsk.com, 21. www.gsk.com, 22. www.gsk.com, 23. www.gsk.com, 24. www.marketwatch.com, 25. www.investing.com, 26. www.gsk.com, 27. www.gsk.com, 28. www.theguardian.com, 29. www.biospace.com, 30. www.reuters.com, 31. www.reuters.com, 32. www.gsk.com, 33. www.gsk.com, 34. www.reuters.com, 35. www.reuters.com, 36. www.biospace.com, 37. www.londonstockexchange.com, 38. www.biospace.com, 39. www.reuters.com, 40. www.gsk.com, 41. www.biospace.com, 42. www.reuters.com, 43. www.gsk.com, 44. www.gsk.com, 45. www.reuters.com, 46. www.reuters.com, 47. www.reuters.com, 48. www.fda.gov, 49. www.gsk.com, 50. www.reuters.com, 51. www.londonstockexchange.com, 52. www.londonstockexchange.com, 53. www.gsk.com, 54. www.gsk.com, 55. www.gsk.com, 56. www.gsk.com, 57. www.gsk.com, 58. www.gsk.com, 59. www.gsk.com, 60. www.marketwatch.com, 61. www.investing.com, 62. www.gsk.com, 63. www.gsk.com, 64. www.theguardian.com, 65. www.biospace.com, 66. www.reuters.com, 67. www.reuters.com, 68. www.gsk.com, 69. www.reuters.com, 70. www.reuters.com, 71. www.biospace.com, 72. www.gsk.com
