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GSK's Exdensur Gets FDA Nod for Severe Asthma Treatment
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Key Takeaways
GSK gets FDA nod for Exdensur as an add-on maintenance treatment for severe eosinophilic asthma.
Exdensur cut annualized asthma exacerbations versus placebo in phase III SWIFT-1 and SWIFT-2 studies.
Exdensur is the first twice-yearly biologic for asthma, while its CRSwNP FDA decision remains pending.
GSK plc (GSK - Free Report) announced that the FDA has approved Exdensur (depemokimab-ulaa), an ultra-long-acting IL-5–targeting biologic, as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adult and pediatric patients aged 12 years and above.
Following the latest FDA nod, Exdensur has become the first and only ultra-long-acting biologic administered twice yearly to receive approval for patients with severe eosinophilic asthma.
The FDA approval for Exdensur in the asthma indication was based on data from the phase III SWIFT-1 and SWIFT-2 studies.
Data from the studies showed that treatment with Exdensur with a twice-yearly dosing regimen led to a significantly lower rate of annualized asthma exacerbations versus placebo. Also, treatment with Exdensur demonstrated a significant 58% and 48% reduction in the rate of annualized exacerbations (asthma attacks) over 52 weeks versus placebo from SWIFT-1 and SWIFT-2 studies, respectively.
Treatment with Exdensur was generally well-tolerated in both studies, with side effects similar to those seen with placebo.
GSK’s Price Performance
Shares of GSK have grown 26.3% in the past six months compared with the industry’s rise of 22.1%.
Image Source: Zacks Investment Research
GSK’s Development Activities With Exdensur
Besides asthma, Exdensur was also under review in the United States for treating chronic rhinosinusitis with nasal polyps (CRSwNP). A decision from the FDA was expected simultaneously with the asthma indication.
However, as things stand, the regulatory body in the United States has yet to make a decision on Exdensur related to the CRSwNP indication.
Earlier this week, the Exdensur was approved in the United Kingdom for the treatment of asthma with type 2 inflammation and CRSwNP.
Last week, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency issued a positive opinion recommending approval of depemokimab in Europe for two indications, severe asthma with type 2 inflammation and CRSwNP.
A final decision from the European Commission is expected in the first quarter of 2026.
GSK's Respiratory Portfolio
Sales in GSK’s respiratory portfolio are currently being driven by its blockbuster drug, Nucala, which is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation.
Nucala is currently approved in the United States and Europe for four types of IL-5-mediated conditions. These are severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (in patients aged six and above), CRSwNP and hyper-eosinophilic syndrome.
The drug was approved for the treatment of chronic obstructive pulmonary disease (“COPD”) in the United States in May 2025, marking its fifth approved use.
Last week, the CHMP also rendered a positive opinion recommending the approval of Nucala as an add-on maintenance treatment for COPD. A final decision in Europe is expected in early 2026.
Sales of Nucala increased 13% at a constant exchange rate in the first nine months of 2025 to £1.44 billion, driven by strong performance across all markets.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. EPS estimates for 2026 have moved up from $7.81 to $8.08 during the same period. ANIP stock has rallied 25.4% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has lost 15.8% in the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 64 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.82 to $1.06. In the past six months, shares of CSTL have surged 106.5%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.
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GSK's Exdensur Gets FDA Nod for Severe Asthma Treatment
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA has approved Exdensur (depemokimab-ulaa), an ultra-long-acting IL-5–targeting biologic, as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adult and pediatric patients aged 12 years and above.
Following the latest FDA nod, Exdensur has become the first and only ultra-long-acting biologic administered twice yearly to receive approval for patients with severe eosinophilic asthma.
The FDA approval for Exdensur in the asthma indication was based on data from the phase III SWIFT-1 and SWIFT-2 studies.
Data from the studies showed that treatment with Exdensur with a twice-yearly dosing regimen led to a significantly lower rate of annualized asthma exacerbations versus placebo. Also, treatment with Exdensur demonstrated a significant 58% and 48% reduction in the rate of annualized exacerbations (asthma attacks) over 52 weeks versus placebo from SWIFT-1 and SWIFT-2 studies, respectively.
Treatment with Exdensur was generally well-tolerated in both studies, with side effects similar to those seen with placebo.
GSK’s Price Performance
Shares of GSK have grown 26.3% in the past six months compared with the industry’s rise of 22.1%.
Image Source: Zacks Investment Research
GSK’s Development Activities With Exdensur
Besides asthma, Exdensur was also under review in the United States for treating chronic rhinosinusitis with nasal polyps (CRSwNP). A decision from the FDA was expected simultaneously with the asthma indication.
However, as things stand, the regulatory body in the United States has yet to make a decision on Exdensur related to the CRSwNP indication.
Earlier this week, the Exdensur was approved in the United Kingdom for the treatment of asthma with type 2 inflammation and CRSwNP.
Last week, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency issued a positive opinion recommending approval of depemokimab in Europe for two indications, severe asthma with type 2 inflammation and CRSwNP.
A final decision from the European Commission is expected in the first quarter of 2026.
GSK's Respiratory Portfolio
Sales in GSK’s respiratory portfolio are currently being driven by its blockbuster drug, Nucala, which is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation.
Nucala is currently approved in the United States and Europe for four types of IL-5-mediated conditions. These are severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (in patients aged six and above), CRSwNP and hyper-eosinophilic syndrome.
The drug was approved for the treatment of chronic obstructive pulmonary disease (“COPD”) in the United States in May 2025, marking its fifth approved use.
Last week, the CHMP also rendered a positive opinion recommending the approval of Nucala as an add-on maintenance treatment for COPD. A final decision in Europe is expected in early 2026.
Sales of Nucala increased 13% at a constant exchange rate in the first nine months of 2025 to £1.44 billion, driven by strong performance across all markets.
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 - Free Report) , CorMedix (CRMD - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. EPS estimates for 2026 have moved up from $7.81 to $8.08 during the same period. ANIP stock has rallied 25.4% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has lost 15.8% in the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 64 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.82 to $1.06. In the past six months, shares of CSTL have surged 106.5%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.