GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment for review. A decision from the regulatory body is expected on May 7, 2025.
GSK’s Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation. Please note that Nucala is already approved in the United States for four IL-5-mediated conditions — severe eosinophilic asthma (aged 6+), chronic rhinosinusitis with nasal polyps in adults, eosinophilic granulomatosis with polyangiitis in adults and hypereosinophilic syndrome in patients aged 12+. Currently, the drug is not approved for COPD worldwide.
In the past three months, shares of GSK have plunged 21.6% compared with the industry’s 6.2% decline.
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More on the FDA Acceptance of GSK’s Nucala Filing for COPD
GSK’s regulatory filing seeking the approval of Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype was supported by positive data from its phase III MATINEE study. The late-stage study evaluated the efficacy and safety of the drug in 804 patients with COPD who have evidence of type 2 inflammation detected by blood eosinophil count, a biomarker.
The MATINEE study achieved its primary endpoint, demonstrating that adding Nucala to inhaled maintenance therapy significantly and meaningfully reduced the annualized rate of moderate to severe exacerbations compared to placebo in patients treated for 52 to 104 weeks. Subject to approval, Nucala can become the first approved biologic with monthly dosing for patients with COPD.
COPD is a progressive and heterogeneous inflammatory lung disease that encompasses chronic bronchitis and emphysema. It ranks as the third leading cause of death, accounting for more than three million fatalities each year. In the United States, it impacts more than 14 million people, leading to approximately 500,000 hospitalizations and up to 1.3 million emergency department visits yearly, costing the U.S. healthcare system around $7 billion.
Filing for Multiple Myeloma Combo Therapy Accepted in China
In a separate press release, GSK announced that the regulatory body in China has accepted its regulatory filing for Blenrep (belantamab mafodotin) combo therapy as a treatment for relapsed or refractory multiple myeloma (RRMM), under the Priority Review pathway. The combo therapy enjoys the Breakthrough Therapy designation in China for the RRMM indication, which is intended to expedite the development process of the novel therapy.
The new drug application for Blenrep, in combination with J&J’s Velcade (bortezomib) plus dexamethasone (BVd), is supported by interim results of the phase III head-to-head DREAMM-7 study. The late-stage study achieved the primary endpoint demonstrating a statistically significant and clinically meaningful improvement in progression-free survival for BVd compared to standard-of-care (SoC) triplet combo in RRMM patients. Per data from a subsequent interim analysis, the DREAMM-7 study also met its key secondary endpoint of overall survival, showing that treatment with the Blenrep combo significantly reduced the risk of death compared to SoC treatment.
Regulatory applications seeking approval for the combination use of Blenrep in RRMM are also currently under review in six other major countries, including the United States, the EU and the U.K.
GSK PLC Sponsored ADR Price and Consensus
GSK PLC Sponsored ADR price-consensus-chart | GSK PLC Sponsored ADR Quote
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Alnylam Pharmaceuticals ALNY, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, Alnylam Pharmaceuticals’ loss estimates have narrowed from 42 cents to 39 cents per share for 2024, while that for 2025 has narrowed from 49 cents to 13 cents. ALNY shares neither gained nor lost in the past three months.
Alnylam Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.
In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 13.5% in the past three months.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 13.1% in the past three months.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.
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