Regeneron & Sanofi Get FDA’s Green Light for Dupixent

Co-developed by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ: SNY), Dupixent has bagged the U.S. Food and Drug Administration’s approval to treat eosinophilic esophagitis (EoE), an allergic condition that happens in the esophagus. With this, Dupixent has become the only available drug for the treating of EoE in the U.S.

The companies also announced that the European Medicines Agency is currently reviewing the drug. Also, several more submissions in other countries are scheduled during the year.

The approval is based on a Phase 3 trial conducted on patients aged 12 years and older with EoE, weighing at least 40 kg. The results showed a remarkable reduction in disease symptoms in comparison with a placebo.

“It is gratifying that Dupixent, a medicine that we invented in our laboratories, is now approved in yet another disease marked by allergic or type 2 inflammation, namely eosinophilic esophagitis,” said George D. Yancopoulos, M.D., Ph.D., the President and Chief Scientific Officer at Regeneron.

The Global Head of Research and Development at Sanofi, John Reed, M.D., Ph.D., said, “Our Phase 3 clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease. This is a landmark FDA approval for patients and their caregivers who now have a new option for treating this devastating disease.”

Stock Rating

Recently, Credit Suisse analyst Lorenzo Biasio maintained a Buy rating on Regeneron with a price target of $725, implying 9.7% upside potential to current levels.

The rest of the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on six Buys, six Holds and one Sell. Regeneron’s average price target of $681.31 implies 3.1% upside potential to current levels.

Hedge Funds’ Activity

TipRanks’ Hedge Fund Trading Activity tool shows that the confidence of hedge funds in Regeneron is currently Very Positive, as the cumulative change in holdings across all 12 hedge funds that were active in the last quarter was an increase of 1.9 million shares.

Takeaway

The FDA’s approval of Dupixent marks a major success for the company, as it has become the only available medicine in the U.S. to treat EoE so far. Meanwhile, Regeneron’s efforts to expand its medicines to other countries look impressive.

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