GSK Stock Stumbles: Mixed EU Respiratory Drug Approvals Spark Investor Jitters

GSK shares took a hit today, caught in the crossfire of Europe's regulatory maze. The pharma giant's respiratory pipeline just got a dose of harsh reality.

The Regulatory Rollercoaster

Approvals came through, but not the clean sweep investors were banking on. The European Medicines Agency delivered a mixed verdict on GSK's latest respiratory treatments, sending a clear signal: navigating Brussels' bureaucracy is still a high-stakes gamble for big pharma. One analyst quipped it's like watching a hedge fund manager try to explain a quarterly loss—lots of moving parts, but the bottom line is all anyone cares about.

Market Punishes Uncertainty

The street hates ambiguity more than it loves potential. While some doors in the EU opened, others remained firmly shut, creating precisely the kind of uncertainty that triggers sell-offs. It's a classic case of 'good news, but not good enough'—the kiss of death for momentum stocks in any sector.

Portfolio Pressure Points

This stumble highlights the inherent risk in relying on blockbuster drug approvals to drive growth. When regulatory winds shift, even the most robust pipelines can spring leaks. For a company of GSK's scale, these respiratory drugs aren't just treatments; they're calculated bets placed years in advance with billions in R&D chips on the table.

One cynical take? This is just another day in the pharmaceutical casino, where the house (regulators) always changes the rules after you've placed your bet. The real drug here might be the volatility itself—and investors just got their next fix.

TLDRs;

• GSK shares fell as mixed EU approvals create uncertainty in respiratory portfolio growth forecasts.
• Depemokimab awaits FDA decision, a key catalyst likely to influence near-term stock sentiment.
• Nucala and Arexvy EU approvals expand respiratory and RSV coverage, supporting medium-term revenue potential.
• Buybacks and dividend reinvestment programs offer limited support amid cautious analyst outlooks.

GlaxoSmithKline plc (GSK) stock faced downward pressure on Monday as investors weighed the implications of recent European regulatory actions for its respiratory portfolio.

While the EMA’s CHMP provided positive recommendations for multiple respiratory drugs, the news was tempered by cautious language and pending final approvals, leaving traders hesitant to bid the stock higher.

On the London Stock Exchange, GSK ordinary shares opened around 1,816p, slightly below recent levels, while the ADR on the NYSE last traded NEAR $48.81. Analysts suggest that the near-term volatility reflects the market’s focus on upcoming regulatory catalysts rather than broader fundamental shifts.

GSK plc, GSK

Depemokimab FDA Decision Nears

Investors are closely watching the FDA’s impending decision for depemokimab, GSK’s long-acting anti-IL-5 antibody designed for severe asthma and chronic rhinosinusitis with nasal polyps. Scheduled for December 16, the decision could have immediate effects on market sentiment.

Depemokimab is positioned as a twice-yearly treatment, potentially offering predictable revenue streams and better adherence compared to existing biologics.

While Europe’s CHMP recommended approval for the drug earlier this month, the European Commission is expected to issue a final ruling in early 2026. This “two-step” regulatory sequence has the potential to influence both short-term trading and medium-term growth forecasts.

Nucala and Arexvy Expand EU Coverage

Alongside depemokimab, GSK secured positive CHMP opinions for Nucala, an eosinophilic COPD treatment, and Arexvy, its RSV vaccine for adults aged 18 and above. These approvals broaden GSK’s respiratory and vaccine footprint, particularly in high-burden COPD populations and adult RSV prevention.

While both products reinforce GSK’s multi-product strategy, analysts caution that final European Commission approvals are still pending, and the real stock-driving question lies in uptake, competition, and pricing dynamics. The EMA backing supports the narrative of a diversified respiratory franchise but does not eliminate near-term uncertainty.

Portfolio Support from Buybacks and Dividends

GSK has continued its shareholder return programs, including a third tranche of buybacks totaling £0.3 billion and DRIP elections for the Q3 2025 dividend. While such measures provide mechanical support and signal management confidence, they have so far been insufficient to offset investor caution surrounding regulatory timing and product adoption.

Analyst consensus remains neutral-to-mixed, with average 12-month price targets clustering near current trading levels. Street forecasts project 2025 turnover of £32.5 billion, rising to £34.1 billion in 2026, with the respiratory and vaccine portfolio driving medium-term growth. However, near-term trading is expected to remain sensitive to FDA and EU outcomes.

Looking Ahead

Investors are keeping a close eye on a series of upcoming events that could shape GSK’s near-term performance. The immediate focus is on December 16, when the FDA is set to announce its decision on depemokimab for severe asthma and chronic rhinosinusitis with nasal polyps.

Following this, early 2026 is expected to bring final rulings from the European Commission for both depemokimab and Nucala, which could significantly influence GSK’s respiratory franchise in Europe. In February 2026, the company anticipates broader EU approval for its Arexvy vaccine for adults, potentially expanding its market reach in the RSV segment.

Finally, on February 4, 2026, GSK will release its full-year financial results along with updated guidance, providing investors with a comprehensive view of portfolio execution and growth prospects.

Collectively, these developments place GSK in a high-catalyst period, where regulatory approvals, product adoption, and strategic execution will be key determinants of the company’s trajectory for 2026 and beyond.