Regeneron’s Dupixent Gets Label Extension in Europe to Include Atopic Dermatitis in Adults

The European Medicines Agency is updating the summary of product characteristics (SmPC) of Regeneron Pharmaceuticals (REGN) and Sanofi’s (SNY) Dupixent to include the long term safety profile in adults with severe atopic dermatitis, after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Don't Miss our Black Friday Offers:

Unlock your investing potential with TipRanks Premium - Now At 40% OFF!
Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter

The SmPC update comes after data from a Phase 3 open-label extension trial demonstrated the long-term safety profile of the drug up to three years in atopic dermatitis to be consistent with observations from earlier Phase 3 trials.

The disease is characterized by severe and persistent itching and skin lesions that can spread to most of the body. At present, Dupixent is the only biologic with approval in the European Union (EU) for treating dermatitis.

So far, over 260,000 patients have been treated with the drug across more than 60 countries. Furthermore, Dupixent is also being evaluated in a number of conditions including pediatric asthma, chronic obstructive pulmonary disease, and bullous pemphigoid. (See Regeneron stock chart on TipRanks)

On June 14, Argus Research analyst Jasper Hellweg reiterated a Buy rating on the stock with a price target of $590 (6.9% upside potential).

Hellweg believes investors have booked gains in the stock after strong growth in 2019-2020, which has contributed to its price underperformance over the past year. Nonetheless, the analyst sees a return to growth for Regeneron on the back of key positives such as its REGN-COV cocktail for COVID-19 and Libtayo in basal cell carcinoma.

Based on 7 Buys and 3 Holds, consensus on the Street is a Moderate Buy. The average Regeneron price target of $630.11 implies 14.2% upside potential. Shares are down 9.9% over the past year.