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AstraZeneca's (AZN) Fasenra sBLA for Nasal Polyps Gets CRL
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AstraZeneca (AZN - Free Report) announced that the FDA has issued a complete response letter to its supplemental biologics license application (sBLA) seeking approval of its drug Fasenra for treating patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The sBLA was based on data from the phase III OSTRO study, which met both co-primary endpoints. Data from the study showed that treatment with Fasenra led to a statistically significant improvement in the size of nasal polyps and nasal blockage in such patients.
In the CRL, the FDA asked for additional clinical data. Another phase III study, ORCHID, is ongoing on Fasenra for CRSwNP. The company is working with the FDA to decide on the next steps.
AstraZeneca stock has risen 26.9% in the past year compared with an increase of 22.3% for the industry.
Image Source: Zacks Investment Research
CRSwNP is an inflammatory disease that can lead to elevated levels of eosinophils in the upper respiratory tract and benign growth called nasal polyps. Patients with polyps can suffer from nasal blockage, which can cause breathing issues, reduction or loss in the sense of smell, sleep disturbances and other adverse effects on the quality of life.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, Europe, Japan and other countries.
Fasenra is one of AstraZeneca’s key drugs driving its product sales growth. The drug recorded sales of $1.25 billion in 2021, representing growth of 31% at a constant exchange rate. According to AstraZeneca, Fasenra enjoys a leadership position among novel biologic asthma medicines in Europe and Japan.
Meanwhile, several label expansion studies are ongoing for Fasenra for eosinophil-driven diseases (EDDs) beyond severe asthma and CRSwNP like chronic obstructive pulmonary disease (COPD), bullous pemphigoid, atopic dermatitis, hypereosinophilic syndrome and others.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Vertex Pharmaceuticals’ stock has risen 10.1% this year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.39 to $14.52 per share, while the same for 2023 have increased from $14.10 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong, with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
Voyager Therapeutics’ loss estimates narrowed from $2.20 per share to $1.35 per share for 2022 and from $1.93 per share to $1.37 per share for 2023 in the past 60 days. Voyager Therapeutics’ stock is up 128.8% this year so far.
Voyager Therapeutics’ earnings performance has been decent, with the company beating earnings expectations in three of the last four quarters while missing in one. Voyager Therapeutics has a four-quarter earnings surprise of 41.0%, on average.
Estimates for Gamida Cell’s 2022 bottom line have narrowed from a loss of $1.83 to $1.35 per share in the past 60 days. Gamida Cell’s stock is up 31.5% this year so far.
Gamida Cell beat estimates in two of the last four quarters while missing in the other two, with the average negative surprise being 22.6%.
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AstraZeneca's (AZN) Fasenra sBLA for Nasal Polyps Gets CRL
AstraZeneca (AZN - Free Report) announced that the FDA has issued a complete response letter to its supplemental biologics license application (sBLA) seeking approval of its drug Fasenra for treating patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The sBLA was based on data from the phase III OSTRO study, which met both co-primary endpoints. Data from the study showed that treatment with Fasenra led to a statistically significant improvement in the size of nasal polyps and nasal blockage in such patients.
In the CRL, the FDA asked for additional clinical data. Another phase III study, ORCHID, is ongoing on Fasenra for CRSwNP. The company is working with the FDA to decide on the next steps.
AstraZeneca stock has risen 26.9% in the past year compared with an increase of 22.3% for the industry.
Image Source: Zacks Investment Research
CRSwNP is an inflammatory disease that can lead to elevated levels of eosinophils in the upper respiratory tract and benign growth called nasal polyps. Patients with polyps can suffer from nasal blockage, which can cause breathing issues, reduction or loss in the sense of smell, sleep disturbances and other adverse effects on the quality of life.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, Europe, Japan and other countries.
Fasenra is one of AstraZeneca’s key drugs driving its product sales growth. The drug recorded sales of $1.25 billion in 2021, representing growth of 31% at a constant exchange rate. According to AstraZeneca, Fasenra enjoys a leadership position among novel biologic asthma medicines in Europe and Japan.
Meanwhile, several label expansion studies are ongoing for Fasenra for eosinophil-driven diseases (EDDs) beyond severe asthma and CRSwNP like chronic obstructive pulmonary disease (COPD), bullous pemphigoid, atopic dermatitis, hypereosinophilic syndrome and others.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector include Vertex Pharmaceuticals (VRTX - Free Report) , Voyager Therapeutics (VYGR - Free Report) and Gamida Cell , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ stock has risen 10.1% this year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.39 to $14.52 per share, while the same for 2023 have increased from $14.10 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong, with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
Voyager Therapeutics’ loss estimates narrowed from $2.20 per share to $1.35 per share for 2022 and from $1.93 per share to $1.37 per share for 2023 in the past 60 days. Voyager Therapeutics’ stock is up 128.8% this year so far.
Voyager Therapeutics’ earnings performance has been decent, with the company beating earnings expectations in three of the last four quarters while missing in one. Voyager Therapeutics has a four-quarter earnings surprise of 41.0%, on average.
Estimates for Gamida Cell’s 2022 bottom line have narrowed from a loss of $1.83 to $1.35 per share in the past 60 days. Gamida Cell’s stock is up 31.5% this year so far.
Gamida Cell beat estimates in two of the last four quarters while missing in the other two, with the average negative surprise being 22.6%.