GSK's Nucala for COPD and Depemokimab for Asthma Get CHMP Nod in EU

GSK plc GSK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Nucala as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).

The European Commission’s final decision is expected in early 2026. If approved, Nucala would provide a new monthly injectable treatment option for millions of Europeans with COPD who remain uncontrolled on inhaled triple therapy and have raised blood eosinophil count, helping to reduce hospital visits and slow down disease progression.

Over the past year, GSK’s shares have surged 45.3% compared with the industry’s 12.4% rise.

Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation.

The drug was approved for the treatment of COPD in the United States in May 2025, marking its fifth approved use.

GSK already markets Nucala in both Europe and the United States for four other IL-5-mediated conditions. These are severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA) (in patients aged 6 and above), chronic rhinosinusitis with nasal polyps (CRSwNP), and hyper-eosinophilic syndrome (HES).

The CHMP also issued a positive opinion recommending approval of depemokimab, an investigational ultra-long-acting IL-5–targeting biologic in Europe for two indications- severe asthma with type 2 inflammation and CRSwNP.

 A final regulatory decision in Europe is anticipated in the first quarter of 2026. If approved, depemokimab would be the first and only ultra-long-acting biologic for the treatment of both severe asthma with type 2 inflammation and CRSwNP.

Depemokimab is also under review in the United States for the two indications, with a decision expected later this week.

The positive opinion is supported by data from phase III SWIFT and ANCHOR studies, which demonstrated sustained efficacy with a twice-yearly dosing regimen. Data from the studies demonstrated the potential of depemokimab to provide ultra-long-acting protection from asthma exacerbations as well as to alleviate symptoms associated with CRSwNP through twice-yearly dosing.

GSK’s Zacks Rank & Stocks to Consider

GSK currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL. ANIP, CRMD and CSTL currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. Over the same period, EPS estimates for 2026 have surged from $7.79 to $8.15. Shares of ANIP have surged 42.6% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD surged 38.2% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 65 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $2.10 to $1.06. CSTL stock has rallied 34.2% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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