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PHILADELPHIA - The US Food and Drug Administration has recently approved Nucala (mepolizumab) for use as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This decision by the FDA is supported by the results of the MATINEE and METREX phase III clinical trials. GSK, with its robust market capitalization of $77.92 billion and impressive gross profit margin of 71.92%, continues to strengthen its position in the pharmaceutical sector. According to InvestingPro data, the company maintains a healthy dividend yield of 4.38% and has consistently paid dividends for 25 consecutive years.
The trials demonstrated that mepolizumab significantly reduced the annual rate of moderate to severe exacerbations in COPD patients when compared to a placebo. These exacerbations, which can lead to hospitalization and emergency department visits, are critical to manage as they can result in irreversible lung damage and increased mortality. The safety profile of mepolizumab was comparable to that of the placebo.
Nucala is the only approved biologic that has been studied in COPD patients with an eosinophilic phenotype characterized by blood eosinophil counts starting at 150 cells/µL. This is significant because nearly 70% of COPD patients in the US inadequately controlled on inhaled triple therapy have a blood eosinophil count at or above this level, representing over a million individuals who could benefit from this treatment option. With annual revenue of $40.73 billion and a "GREAT" financial health score according to InvestingPro, GSK demonstrates strong operational capabilities to support this major product launch.
Kaivan Khavandi, SVP at GSK, emphasized the importance of this approval for providing a new treatment option for COPD patients, particularly those with frequent exacerbations requiring hospitalization. Jean Wright, CEO of the COPD Foundation, also highlighted the ongoing challenge of managing exacerbations for individuals living with COPD and expressed optimism for biologics like mepolizumab.
Mepolizumab works by targeting and binding to interleukin-5 (IL-5), which plays a key role in type 2 inflammation associated with COPD. The drug is already approved for use in several other IL-5 mediated conditions in the US and Europe.
GSK, the company behind Nucala, has a history of developing respiratory treatments and continues to focus on improving outcomes for people with various respiratory diseases. The approval of Nucala for COPD in the US is a step forward for patients needing additional treatment options. Regulatory submissions for the use of mepolizumab in COPD are currently under review in China and Europe. For investors seeking deeper insights into GSK’s market position and growth potential, InvestingPro offers comprehensive analysis through its Pro Research Report, available for over 1,400 top stocks including GSK. This report is based on a press release statement from GSK.
In other recent news, GSK reported first-quarter earnings and revenue that exceeded analyst expectations, driven by notable growth in its Specialty Medicines segment. The company posted adjusted earnings per share of $1.20, surpassing the consensus estimate of $1.02, with revenue reaching $10.06 billion, above the expected $9.48 billion. GSK also reaffirmed its full-year 2025 guidance, projecting turnover growth of 3% to 5% and core operating profit growth of 6% to 8%. Additionally, GSK announced the acquisition of efimosfermin alfa, a treatment for steatotic liver disease, from Boston Pharmaceuticals for $1.2 billion upfront, with potential success-based milestones totaling $800 million. This acquisition is expected to expand GSK’s hepatology pipeline and aligns with its focus on immune system-related R&D. In contrast, GSK decided to terminate the development program for belrestotug, an anti-TIGIT monoclonal antibody, due to insufficient efficacy results in phase 2 studies. Despite this setback, GSK continues to focus on its oncology pipeline, which includes promising programs targeting B7-H3 and B7-H4. The company also declared a quarterly dividend and continued its share buyback program, purchasing £273 million of shares as part of a £2 billion initiative.
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