Yahoo Finance Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD
Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY have obtained the European Commission’s (EC) approval for a label expansion of their asthma drug Dupixent (dupilumab).
The drug is now approved in the European Union (EU) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD), characterized by raised blood eosinophils. The approval of the COPD indication represents the sixth approved indication for Dupixent in the EU.
The approval was mostly expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion recommending the approval of Dupixent for COPD in May 2024.
This latest EC approval is based on positive results from two late-stage studies, BOREAS and NOTUS, which evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe COPD with evidence of type 2 inflammation. Results showed that Dupixent significantly reduced exacerbations and improved lung function and health-related quality of life.
COPD is a respiratory disease that damages the lungs and causes progressive lung function decline. It is the fourth leading cause of death worldwide. Smoking and exposure to noxious particles are key risk factors for COPD.
Per Regeneron and Sanofi, Dupixent is the first new treatment approach for COPD in more than a decade. The approval makes Dupixent a new treatment option for approximately 220,000 adults in the EU.
While Sanofi records global net product sales of Dupixent and Kevzara, Regeneron records its share of profit in connection with the global sales of these drugs.
The label expansion of Dupixent in the COPD indication should further boost sales of this blockbuster drug.
Dupixent is a key top-line driver for both Sanofi and Regeneron. Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line.
Regeneron’s shares have risen 19% year to date against the industry’s decline of 7.1%. Sanofi’s shares have lost 2.4% year to date against the industry’s 21.1% growth.
Image Source: Zacks Investment Research
Image Source: Zacks Investment Research
During first-quarter 2024, Sanofi recorded €2.84 billion from Dupixent product sales, indicating a 25% year-over-year growth. Sanofi expects Dupixent to achieve about €13 billion in sales by this year’s end.
Sanofi and Regeneron are striving to expand the drug’s label further. Both companies are evaluating the drug in a broad range of diseases driven by type II inflammation or other allergic processes, including chronic pruritus of unknown origin and bullous pemphigoid.
However, the FDA has extended its review period for a regulatory filing seeking label expansion of Dupixent in the COPD indication by an additional three months. A final decision is now expected by Sep 27, 2024.
The regulatory body had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. The agency determined that this additional information, which was submitted, constituted a major amendment to the data filed in its earlier regulatory filing and extended the target action date.
Regeneron and Sanofi are also evaluating itepekimab for the treatment of COPD.
Zacks Rank and Stocks to Consider
SNY currently carries a Zacks Rank #3 (Hold), while REGN has a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the biotech sector are ALX Oncology Holdings ALXO and Minerva Neurosciences, Inc. NERV, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 90 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. The loss per share estimate for 2025 has narrowed from $4.54 to $3.60.
NERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%.
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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
Sanofi (SNY) : Free Stock Analysis Report
Minerva Neurosciences, Inc (NERV) : Free Stock Analysis Report
ALX Oncology Holdings Inc. (ALXO) : Free Stock Analysis Report
