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Regeneron Wins FDA’s Trust to Treat Skin Lesions in Children
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Regeneron Wins FDA’s Trust to Treat Skin Lesions in Children

Story Highlights

Regeneron’s Dupixent getting approval for children opens up a new treatment option for atopic dermatitis among the younger cohort.

Biotechnology company Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently revealed that its injectable medicine to treat atopic dermatitis, Dupixent, has received approval from the Food and Drug Administration (FDA) for use in children aged 6 months to 5 years. The company has developed this medicine in partnership with Sanofi.

Shares of Regeneron gained marginally to close at $613.98 on Tuesday.

Details of the Approval

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Its symptoms include intense, persistent itch and skin lesions that cover much of the body. As many as 75,000 children, aged 5 or younger, are suffering from this disease in the United States.

In its phase 3 trial, which was conducted on 162 children aged 6 months to 5 years, the company found that with the administration of Dupixent there was a 75% improvement in eczema area and severity index at week 16.

Along with atopic dermatitis, Dupixent is also used to treat asthma, chronic rhinosinusitis with nasal polyposis or eosinophilic esophagitis in different countries around the world.

Management’s Take

The Chief Scientific Officer at Regeneron, George D. Yancopoulos, said, “Dupixent has changed the atopic dermatitis treatment paradigm – significantly clearing skin and reducing itch – by targeting an underlying cause of this disease without broadly suppressing the immune system. Today’s approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any U.S. patient aged six months or older living with this debilitating disease.”

Stock Rating

Overall, the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on eight Buys, six Holds and two Sells. REGN’s average price target of $681.56 implies that the stock has upside potential of 11% from current levels. Shares have grown 21.2% over the past year.

Investors’ Sentiment

TipRanks’ Stock Investors tool shows that top investors currently have a Positive stance on REGN, as 2.2% of the top portfolios tracked by TipRanks increased their exposure to BX stock over the past 30 days.

Conclusion

The approval of Dupixent for children opens up a sizeable market for Regeneron, which, in turn, is expected to aid its profitability.

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