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Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).
The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.
The FDA had issued a complete response letter (CRL) for the first sBLA seeking approval of Dupixent for CSU in October last year for want of more data.
Sanofi’s stock has declined 3.5% so far this year against an increase of 3.4% for the industry.
Image Source: Zacks Investment Research
CSU is an inflammatory skin condition, primarily occurring due to type 2 inflammation. This causes sudden and debilitating hives and swelling on the skin, which is mostly inadequately controlled by antihistamine treatment. The second sBLA for Dupixent in CSU was based on new data from the pivotal phase III study called LIBERTY-CUPID Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Data from Study C confirmed that Dupixent significantly reduced itch and hive activity. The original sBLA was supported by positive data from two phase III studies, LIBERTY-CUPID Studies A and B.
Dupixent is already approved for the CSU indication in Japan while it is under review in the EU.
Dupixent – Key Top-Line Driver for SNY, REGN
Dupixent is now approved in several countries, including the United States and EU, for six type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
Dupixent is being jointly marketed by Regeneron and Sanofi 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 is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first nine months of 2024, Dupixent generated global product sales of $€9.6 billion, which were recorded by Sanofi, representing growth of 25.9% at a constant exchange rate. Sanofi expects Dupixent to achieve more than €13 billion in sales in 2024.
For Regeneron, Dupixent generated collaboration revenues of $3.32 billion in the first nine months of 2024, up 18.2% year over year.
Estimates for Gilead’s 2024 earnings have risen from $3.77 to $4.28 per share over the past 60 days. For 2025, earnings estimates have risen from $7.27 to $7.40 per share over the same timeframe. Year to date, Gilead’s stock has risen 9.2%.
Gilead beat estimates in three of the last four reported quarters, while missing in one, delivering an average earnings surprise of 15.46%.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.66 to $2.88 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.86 per share to $2.92 per share. Pfizer’s shares have declined 13.9% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 74.50%.
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FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
Key Takeaways
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).
The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.
The FDA had issued a complete response letter (CRL) for the first sBLA seeking approval of Dupixent for CSU in October last year for want of more data.
Sanofi’s stock has declined 3.5% so far this year against an increase of 3.4% for the industry.
Image Source: Zacks Investment Research
CSU is an inflammatory skin condition, primarily occurring due to type 2 inflammation. This causes sudden and debilitating hives and swelling on the skin, which is mostly inadequately controlled by antihistamine treatment. The second sBLA for Dupixent in CSU was based on new data from the pivotal phase III study called LIBERTY-CUPID Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Data from Study C confirmed that Dupixent significantly reduced itch and hive activity. The original sBLA was supported by positive data from two phase III studies, LIBERTY-CUPID Studies A and B.
Dupixent is already approved for the CSU indication in Japan while it is under review in the EU.
Dupixent – Key Top-Line Driver for SNY, REGN
Dupixent is now approved in several countries, including the United States and EU, for six type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
Dupixent is being jointly marketed by Regeneron and Sanofi 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 is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first nine months of 2024, Dupixent generated global product sales of $€9.6 billion, which were recorded by Sanofi, representing growth of 25.9% at a constant exchange rate. Sanofi expects Dupixent to achieve more than €13 billion in sales in 2024.
For Regeneron, Dupixent generated collaboration revenues of $3.32 billion in the first nine months of 2024, up 18.2% year over year.
SNY’s Zacks Rank and Stocks to Consider
Sanofi currently has a Zacks Rank #3 (Hold).
Sanofi Price and Consensus
Sanofi price-consensus-chart | Sanofi Quote
Some top-ranked drug/biotech companies are Gilead (GILD - Free Report) and Pfizer (PFE - Free Report) , both with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Gilead’s 2024 earnings have risen from $3.77 to $4.28 per share over the past 60 days. For 2025, earnings estimates have risen from $7.27 to $7.40 per share over the same timeframe. Year to date, Gilead’s stock has risen 9.2%.
Gilead beat estimates in three of the last four reported quarters, while missing in one, delivering an average earnings surprise of 15.46%.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.66 to $2.88 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.86 per share to $2.92 per share. Pfizer’s shares have declined 13.9% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 74.50%.