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Sanofi, Regeneron's Dupixent Gets FDA Approval for COPD
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Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the FDA has approved their blockbuster drug, Dupixent, for its sixth indication — chronic obstructive pulmonary disease (COPD) — in the United States. The approved indication is as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype. With this approval, Dupixent became the first biologic treatment approved for COPD in the United States.
Dupixent was approved for treating COPD with raised blood eosinophils in the EU in July 2024. Dupixent was also approved for the COPD indication in China last week.
Sanofi’s stock has gained 16.0% so far this year compared with an increase of 20.2% for the large cap pharmaceutical industry.
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The approval for COPD, a respiratory disease that causes progressive lung function decline, was based on data from two studies. The NOTUS and BOREAS studies met their primary endpoint by showing that Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34%, respectively. Dupixent also showed improvements in lung function and health-related quality of life compared to placebo.
Earlier this year, the FDA extended its decision on a supplemental biologics license application seeking approval of Dupixent for COPD from June 27 to Sept. 27.
Dupixent – Key Top-Line Driver for SNY, REGN
Dupixent is currently approved in several countries, including the United States and EU, for five other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
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. The approval for the COPD indication can significantly boost sales of Dupixent. Some analysts expect total sales of Dupixent for COPD to be around $6 billion.
Dupixent is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first half of 2024, Dupixent generated global product sales of $€6.1 billion, which were recorded by Sanofi, representing growth of 27.1% 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 $2.06 billion in the first half, up 18% year over year.
Estimates for Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.44 to $23.97 per share over the same timeframe. Year to date, Lilly’s stock has risen 50.5%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.38 to $2.62 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.74 per share to $2.85 per share. Pfizer’s shares have risen 1.0% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.82%.
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Sanofi, Regeneron's Dupixent Gets FDA Approval for COPD
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the FDA has approved their blockbuster drug, Dupixent, for its sixth indication — chronic obstructive pulmonary disease (COPD) — in the United States. The approved indication is as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype. With this approval, Dupixent became the first biologic treatment approved for COPD in the United States.
Dupixent was approved for treating COPD with raised blood eosinophils in the EU in July 2024. Dupixent was also approved for the COPD indication in China last week.
Sanofi’s stock has gained 16.0% so far this year compared with an increase of 20.2% for the large cap pharmaceutical industry.
The approval for COPD, a respiratory disease that causes progressive lung function decline, was based on data from two studies. The NOTUS and BOREAS studies met their primary endpoint by showing that Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34%, respectively. Dupixent also showed improvements in lung function and health-related quality of life compared to placebo.
Earlier this year, the FDA extended its decision on a supplemental biologics license application seeking approval of Dupixent for COPD from June 27 to Sept. 27.
Dupixent – Key Top-Line Driver for SNY, REGN
Dupixent is currently approved in several countries, including the United States and EU, for five other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
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. The approval for the COPD indication can significantly boost sales of Dupixent. Some analysts expect total sales of Dupixent for COPD to be around $6 billion.
Dupixent is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first half of 2024, Dupixent generated global product sales of $€6.1 billion, which were recorded by Sanofi, representing growth of 27.1% 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 $2.06 billion in the first half, up 18% year over year.
SNY Zacks Rank and Other Stocks to Consider
Sanofi currently has a Zacks Rank #2 (Buy).
Sanofi Stock Price and Consensus
Sanofi price-consensus-chart | Sanofi Quote
Some other top-ranked drug/biotech companies are Eli Lilly (LLY - Free Report) and Pfizer (PFE - Free Report) . While Lilly sports a Zacks Rank #1 (Strong Buy), Pfizer has a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.44 to $23.97 per share over the same timeframe. Year to date, Lilly’s stock has risen 50.5%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.38 to $2.62 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.74 per share to $2.85 per share. Pfizer’s shares have risen 1.0% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.82%.