NYSE:GSK

GSK Falls 3.7% as Weak Vaccine Sales and Lower Reported Profit Offset Specialty Medicines Growth

GSK shares fell about 3.7% after the company reported solid third-quarter sales growth but weaker vaccine performance and a sharp decline in reported operating profit.

Third-quarter sales rose 4% to £8.9 billion, or 5% at constant exchange rates. Specialty Medicines led growth with sales up 15%, including 10% growth in HIV, 21% growth in Respiratory, Immunology & Inflammation and 23% growth in Oncology.

Vaccines were the main weak spot. Segment sales declined 2%, with Shingrix down 5% and Arexvy falling 24%, partly offset by 12% growth in meningitis vaccines. General Medicines sales were broadly flat.

Core operating profit increased 5% at constant currencies, while core EPS rose just 1% to 54.6p. Reported operating profit fell 16% and reported EPS declined 21%, mainly because of £328 million of restructuring charges tied to the Accelerate Growth programme and lower other operating income.

GSK reaffirmed its 2026 outlook for 3%-5% sales growth and 7%-9% growth in both core operating profit and core EPS. The company also maintained its goal of more than £40 billion in sales by 2031.

The 3.7% decline appears to reflect investor concern over continued weakness in key vaccines, modest core EPS growth and restructuring-related pressure on reported earnings, despite strong Specialty Medicines momentum and unchanged full-year guidance.
GSK Stock Rises 6.4% as Strong Specialty Medicines Growth and R&D Expansion Boost Confidence

GSK (NYSE: GSK) shares rose 6.4% on Tuesday after the pharmaceutical company reported solid second-quarter results, reaffirmed its full-year guidance, and unveiled plans to accelerate research and development while expanding its late-stage pipeline.

Second-quarter sales increased 5% to £8.4 billion, driven by continued strength in Specialty Medicines and Vaccines. Core operating profit rose 7%, while core EPS increased 9% to 50.5 pence, reflecting higher sales and a favorable product mix despite increased investment in research and development and new product launches. Operating cash flow reached £2.9 billion, with free cash flow totaling £2.0 billion.

Specialty Medicines remained the company’s primary growth engine, with sales climbing 14% to £3.8 billion. Respiratory, Immunology & Inflammation revenue increased 19%, Oncology sales grew 17%, and HIV revenue advanced 10%. Vaccines also delivered a strong performance, with sales rising 8%, supported by robust demand for meningitis vaccines and Arexvy, whose sales more than doubled year over year. General Medicines revenue declined 9%, largely reflecting lower sales of Trelegy and other mature products.

While reported operating profit fell 75% and reported EPS declined 69%, the weakness was primarily driven by a £1.3 billion impairment related to camlipixant and other one-time charges rather than deterioration in the underlying business. Investors instead focused on the company’s improving core performance and strong cash generation.

GSK also announced an ambitious acceleration of its research pipeline. The company now expects to launch more than 20 Phase III clinical trials during 2026, double its previous target, while identifying seven priority assets across 18 indications for accelerated development. Management also announced plans to establish a new flagship R&D center at the Cambridge Biomedical Campus in the UK and introduced a restructuring program targeting £1.9 billion in annual cost savings by 2029.

The company reaffirmed its 2026 guidance, forecasting revenue growth of 3% to 5%, core operating profit growth of 7% to 9%, and core EPS growth of 7% to 9%. Management also reiterated confidence in achieving more than £40 billion in annual sales by 2031.

The strong share price reaction suggests investors looked beyond the headline impairment charges and focused on GSK’s accelerating pharmaceutical pipeline, robust growth in Specialty Medicines, improving profitability, and management’s confidence in sustaining long-term earnings growth.
GSK plc announced that its investigational drug bepirovirsen has been accepted for priority review by the U.S. Food and Drug Administration for the treatment of chronic hepatitis B.

The therapy has also received Breakthrough Therapy Designation, highlighting its potential to significantly improve outcomes compared to existing treatments. The application is supported by Phase III trial data showing meaningful functional cure rates in patients.

The FDA has set a target decision date of October 26, 2026. If approved, bepirovirsen could address a major unmet need, as current therapies often require lifelong treatment and have low cure rates.

Source: GSK
GSK announced that its investigational liver therapy efimosfermin has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

The designations are based on Phase II data showing that once-monthly efimosfermin significantly improved liver fibrosis and helped resolve MASH in patients with moderate to advanced disease, compared to placebo. The therapy also demonstrated a favorable safety profile, with mostly mild and temporary side effects.

MASH, affecting up to 5% of the global population, is a major cause of liver transplants, with limited treatment options currently available—particularly for advanced stages. Efimosfermin is now advancing into Phase III trials, targeting both moderate and severe fibrosis cases, including cirrhosis.
**GSK's Blenrep Approved in China for Relapsed Multiple Myeloma**

GSK has secured approval from China's National Medical Products Administration (NMPA) for Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The approval followed priority review and Breakthrough Therapy Designation.

The decision is backed by data from the Phase III DREAMM-7 trial, in which BVd nearly tripled median progression-free survival compared to a standard daratumumab-based regimen (36.6 months versus 13.4 months) and reduced the risk of death by 42%. Blenrep is now the only anti-BCMA therapy approved for this patient population in China, and notably the only such treatment administered entirely on an outpatient basis as a 30-minute infusion — reducing the burden on both patients and healthcare facilities.

The approval is particularly significant given that multiple myeloma incidence in China has doubled over the past three decades to around 30,000 new cases annually. Blenrep has now received more than 15 regulatory approvals globally, including in the US, EU, UK, and Japan.
London, April 15, 2026 — GSK announced the completion of its $950 million acquisition of 35Pharma, strengthening its pipeline in respiratory and inflammatory diseases.

The deal includes HS235, a clinical-stage therapy targeting pulmonary hypertension (PH), a serious condition affecting around 82 million people globally. The drug focuses on the activin receptor signalling pathway and is designed to improve safety by reducing risks associated with current treatments, such as bleeding.

GSK said HS235 could also offer broader metabolic benefits, including improved insulin sensitivity and fat-selective weight loss, based on early clinical findings. Proof-of-concept trials are expected to begin soon across multiple forms of PH.

The acquisition supports GSK’s strategy to expand its portfolio in chronic diseases and address significant unmet medical needs in pulmonary and cardiovascular conditions.
GSK plc announced that China’s National Medical Products Administration has approved Exdensur (depemokimab) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first ultra-long-acting biologic available for this condition in the country.

The approval allows Exdensur to be used as an add-on therapy for patients who do not achieve adequate disease control with corticosteroids or surgery. The decision is based on Phase III ANCHOR trials, which demonstrated statistically significant reductions in nasal polyp size and improvements in nasal obstruction symptoms over a 52-week period.

Exdensur, administered twice yearly, targets type 2 inflammation by inhibiting interleukin-5 (IL-5), offering a long-lasting treatment option for patients with persistent symptoms. The therapy has shown a safety profile comparable to standard care in clinical studies.

The drug has already received approvals in multiple markets, including the United States, Japan, the European Union, and the UK, for respiratory conditions such as severe asthma and CRSwNP.
GSK announced that China has approved Exdensur (depemokimab) for the treatment of severe asthma with an eosinophilic phenotype.

Exdensur is the first ultra-long-acting biologic in China for this condition, requiring only two doses per year, which could significantly improve treatment convenience and adherence.

The approval is based on Phase III SWIFT trials, where the drug reduced asthma exacerbations by up to 58% compared to placebo and showed strong safety and tolerability.

With more than 2 million severe asthma patients in China, the approval expands GSK’s footprint in respiratory medicine and supports its strategy to redefine treatment standards through long-acting biologics.
GSK plc announced that the European Medicines Agency has accepted for review its investigational therapy Bepirovirsen for the treatment of chronic hepatitis B.

The submission is supported by Phase III B-Well trials, which showed statistically significant and clinically meaningful functional cure rates compared with standard of care alone. The therapy also demonstrated an acceptable safety and tolerability profile.

Bepirovirsen is a potential first-in-class treatment designed to target and suppress hepatitis B virus activity while enabling the immune system to regain control of the infection.

Chronic hepatitis B affects millions of people in Europe and remains a leading cause of liver cancer, with current treatments often requiring lifelong therapy. A regulatory decision on the application is expected following the EMA review process.
GSK announced that its investigational antibody-drug conjugate, risvutatug rezetecan, has received Orphan Drug Designation in Japan for the treatment of small-cell lung cancer.

The designation is supported by early clinical data showing durable responses in patients with extensive-stage disease, a condition with limited treatment options and poor prognosis.

The milestone marks the sixth global regulatory designation for the therapy, reinforcing its potential across multiple solid tumor indications and supporting its ongoing clinical development.
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06-09-26Global Finance News