Nucor earnings beat by $0.08, revenue fell short of estimates
Today, GSK plc (LSE/NYSE: GSK), a prominent pharmaceutical company with a market capitalization of $76.59 billion and impressive gross profit margins of 71.81%, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for depemokimab for two potential indications. According to InvestingPro analysis, GSK currently appears undervalued, suggesting potential upside for investors interested in this development. The applications pertain to the use of depemokimab as an add-on maintenance treatment for asthma in patients 12 years and older with type 2 inflammation, and for adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The submissions are based on the positive outcomes of the SWIFT and ANCHOR trials, which showed significant benefits of depemokimab in reducing exacerbations and hospitalization rates in asthma patients and in decreasing nasal polyp size and nasal obstruction in CRSwNP patients, respectively. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA decision is set for December 16, 2025.
Kaivan Khavandi, SVP and Global Head of Respiratory, Immunology & Inflammation R&D at GSK, commented on the simultaneous regulatory submissions, expressing confidence in depemokimab’s potential to alleviate the burdens of both asthma and CRSwNP on patients and healthcare systems.
Depemokimab is a monoclonal antibody targeting IL-5, a key driver of type 2 inflammation. It is the first ultra-long-acting biologic of its kind to be evaluated in phase III trials for these conditions. The medication’s extended half-life enables a dosing schedule of just two injections per year.
Type 2 inflammation, often identified by blood eosinophil count, is a common factor in many patients with difficult-to-treat asthma and can lead to exacerbations and hospitalization. It is also present in up to 85% of people with CRSwNP, associated with more severe disease and symptoms.
In the US, asthma affects over 26 million individuals, with 40% reporting at least one attack in the past year. Asthma leads to an estimated 100,000 hospitalizations and nearly 1 million emergency department visits annually. CRSwNP affects 2.1% of the US population, with up to 30% having nasal polyps, leading to significant impacts on quality of life.
Depemokimab is not currently approved for use in any country. The phase III development program for depemokimab includes studies in other IL-5 mediated diseases, and its efficacy and safety are being further evaluated in ongoing trials. GSK maintains a strong financial position to support its research initiatives, with InvestingPro data showing an impressive 25-year track record of consistent dividend payments and a current dividend yield of 4.18%. The company’s overall financial health score is rated as "GREAT" by InvestingPro analysts.For investors seeking deeper insights, GSK is among the 1,400+ US equities covered by comprehensive Pro Research Reports, offering detailed analysis of the company’s pipeline, financial metrics, and growth potential. Access these exclusive insights and 8 additional ProTips by visiting InvestingPro.
This news is based on a press release statement.
In other recent news, GSK announced promising results from two phase III trials for depemokimab, a treatment for chronic rhinosinusitis with nasal polyps. The trials demonstrated significant improvements in symptoms with twice-yearly dosing compared to placebo, supporting future regulatory filings. Additionally, GSK completed the acquisition of IDRx, a biopharmaceutical company specializing in precision cancer therapies, for up to $1.15 billion. This acquisition aims to enhance GSK’s oncology portfolio, particularly with IDRX-42, a treatment for gastrointestinal stromal tumors. Furthermore, GSK’s new 5-in-1 meningitis vaccine, Penmenvy, received FDA approval, providing protection against five common serogroups of Neisseria meningitidis for individuals aged 10 to 25. GSK also announced the appointment of Dr. Gavin Screaton as a Non-Executive Director, bringing expertise in immunology and infectious diseases to the Board. Lastly, GSK’s Nucala treatment for COPD is under review by China’s National Medical (TASE:BLWV) Products Administration, following positive phase III trial results. These developments reflect GSK’s ongoing efforts to advance its pipeline and expand treatment options across various therapeutic areas.
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