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Sanofi's (SNY) Dupixent Gets Europe Nod for Prurigo Nodularis
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Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the European Commission (EC) approved their blockbuster medicine Dupixent (dupilumab) for the treatment of adult patients with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Following the EC nod, Dupixent became the first and only targeted treatment approved for prurigo nodularis, a chronic inflammatory skin disorder, in Europe. The FDA approved Dupixent for the same indication in September 2022.
The nod in Europe was based on data from two phase III studies, PRIME and PRIME2, which evaluated the safety and efficacy of Dupixent in adults with prurigo nodularis. Data from the studies showed that patients treated with Dupixent experienced a higher clinically meaningful reduction in itch at 12 weeks compared to placebo.
The approval in Europe was expected as last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency rendered a positive opinion recommending the approval of Dupixent for the prurigo nodularis indication.
Dupixent has been granted an additional one-year marketing protection in the EU, based on the recommendation by the CHMP.
In Europe, Dupixent is presently approved to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as investigational disease eosinophilic esophagitis. Purigo nodularis is now the fourth disease for which Dupixent is approved in Europe.
Dupixent is approved in the United States for five indications — severe CRSwNP, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
The Sanofi stock has lost 4.3% so far this year against the industry’s growth of 12.7%.
Image Source: Zacks Investment Research
Please note that Dupixent is being jointly marketed by REGN and SNY under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent’s frequent label expansion approvals are driving its sales. The drug generated sales worth €5.89 billion in the first nine months of 2022, reflecting an increase of 44.5% at CER year over year.
Sanofi and Regeneron are also studying dupilumab in late-stage studies for a broad range of diseases, driven by type II inflammation like pediatric eosinophilic esophagitis, chronic obstructive pulmonary disease, urticaria and bullous pemphigoid.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed to 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Aeglea BioTherapeutics have narrowed 7.3% for 2022 and 1.2% for 2023 in the past 60 days.
Earnings of Aeglea BioTherapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. AGLE witnessed an earnings surprise of 3.60% on average.
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Sanofi's (SNY) Dupixent Gets Europe Nod for Prurigo Nodularis
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the European Commission (EC) approved their blockbuster medicine Dupixent (dupilumab) for the treatment of adult patients with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Following the EC nod, Dupixent became the first and only targeted treatment approved for prurigo nodularis, a chronic inflammatory skin disorder, in Europe. The FDA approved Dupixent for the same indication in September 2022.
The nod in Europe was based on data from two phase III studies, PRIME and PRIME2, which evaluated the safety and efficacy of Dupixent in adults with prurigo nodularis. Data from the studies showed that patients treated with Dupixent experienced a higher clinically meaningful reduction in itch at 12 weeks compared to placebo.
The approval in Europe was expected as last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency rendered a positive opinion recommending the approval of Dupixent for the prurigo nodularis indication.
Dupixent has been granted an additional one-year marketing protection in the EU, based on the recommendation by the CHMP.
In Europe, Dupixent is presently approved to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as investigational disease eosinophilic esophagitis. Purigo nodularis is now the fourth disease for which Dupixent is approved in Europe.
Dupixent is approved in the United States for five indications — severe CRSwNP, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
The Sanofi stock has lost 4.3% so far this year against the industry’s growth of 12.7%.
Image Source: Zacks Investment Research
Please note that Dupixent is being jointly marketed by REGN and SNY under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent’s frequent label expansion approvals are driving its sales. The drug generated sales worth €5.89 billion in the first nine months of 2022, reflecting an increase of 44.5% at CER year over year.
Sanofi and Regeneron are also studying dupilumab in late-stage studies for a broad range of diseases, driven by type II inflammation like pediatric eosinophilic esophagitis, chronic obstructive pulmonary disease, urticaria and bullous pemphigoid.
Zacks Rank & Other Stocks to Consider
Sanofi currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited (ASLN - Free Report) and Aeglea BioTherapeutics, Inc. , both carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed to 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Aeglea BioTherapeutics have narrowed 7.3% for 2022 and 1.2% for 2023 in the past 60 days.
Earnings of Aeglea BioTherapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. AGLE witnessed an earnings surprise of 3.60% on average.