Regeneron announced Friday that the company won Food and Drug Administration approval for Dupixent in chronic obstructive pulmonary disease, or COPD. Regeneron stock traded higher in early trades.
This is the first biologic treatment approved for patients with COPD, a common lung disease that makes it difficult to breathe. The potential approval date was previously delayed by three months to five the FDA more time to review data from Regeneron Pharmaceuticals' final-phase studies.
COPD patients struggle with breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalizations, said Jean Wright, chief executive of The COPD Foundation.
"These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home," she said in a statement. "We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease."
Regeneron stock has climbed by roughly a third this year, according to MarketSurge. Shares have a strong IBD Digital Composite Rating of 94, putting them in the top 6% of all stocks in terms of fundamental and technical measures.
Regeneron Stock: A Second COPD Approval
Dupixent is the second drug to gain approval as a COPD treatment this year.
In July, the FDA signed off on Verona Pharma's Ohtuvayre. Ohtuvayre is the first inhaled treatment for COPD. It works by blocking enzymes PDE3 and PDE4. This relaxes the muscles in the lungs and widens the airways.
Dupixent, on the other hand, blocks IL-4, an inflammatory cytokine. The blockbuster drug treats a myriad of inflammatory conditions including asthma and eczema. All of these conditions have ties to high levels of type 2 inflammation. Tamping down on IL-4 lowers type 2 inflammation.
RBC Capital Markets analyst Brian Abrahams has an outperform rating on Regeneron stock.
He estimates a potential $6 billion in long-term sales for Dupixent in COPD treatment. Dupixent is already a major moneymaker, generating $11.6 billion in sales last year for Sanofi. Sanofi records global sales of Dupixent, and Regeneron gets a share of its profits.
Piper Sandler analyst Christopher Raymond says he likes the setup for Regeneron. The company is facing a near-term inflection with Dupixent in COPD treatment and a "meaningful pipeline of catalysts on tap this year."
He has an overweight rating on Regeneron stock.
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