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Regeneron, Sanofi Skin Disease Drug Under Priority Review

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) received encouraging news after their biologics license application, for experimental skin disease treatment dupilumab, was accepted for priority review by the FDA. The companies are looking to get dupilumab approved for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD).

With the FDA granting priority review, a response should be out by Mar 29, 2017.

Per company sources, AD affects about 7–8 million adults in the U.S. and 1–3% of adults across the world. Further, there are roughly 1.6 million patients in the U.S. diagnosed with moderate-to-severe AD, that are still living with inadequately controlled disease, in spite of being treated.


Considering the lack of approved systemic treatments in the U.S. for moderate-to-severe AD, there exists significant unmet need for drugs addressing this serious, chronic inflammatory skin disease. Approval would be a huge boost, and dupilumab could bring in blockbuster sales, given the immense commercial potential in the target market.


Apart from AD, dupilumab is being evaluated for additional inflammatory indications including asthma (phase III), nasal polyposis (phase II) and eosinophilic oesophagitis (phase II). A phase III study on dupilumab for nasal polyposis is anticipated to start in the first quarter of 2017.

We note that Pfizer Inc. (PFE - Free Report) is also looking to get its AD treatment, crisaborole topical ointment 2%, approved for the treatment of patients with mild-to-moderate AD. It is currently under FDA review with a response expected by Jan 7, 2017.

Meanwhile, Regeneron and Sanofi have an importantly regulatory event coming up late next month (Oct 30) with the FDA expected to decide on the approval of sarilumab. Sarilumab is currently under review in the U.S. for the treatment of patients with active, moderate-to-severe rheumatoid arthritis. It is also under review in the EU.

While Regeneron is a Zacks Rank #2 (Buy) stock, Sanofi carries a Zacks Rank #4 (Sell).

A Stock to Consider

A better-ranked stock in the health care sector is Ligand Pharmaceuticals Inc. (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

For 2016, Ligand witnessed a 12.13% increase in its earnings estimates over the past 60 days. The company has also posted an average positive earnings surprise of 36.66% over the last four trailing quarters. Its share price has surged nearly 13% year to date.

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