Roth Capital 'Impressed' by Latest Dupixent Data; Affirms Regeneron (REGN) at 'Buy'
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Roth Capital affirms Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) at Buy with a price target of $520 after the company and Sanofi announced that detailed results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase 3 studies evaluating investigational Dupixent (dupilumab) in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in the New England Journal of Medicine (NEJM). The studies met their primary endpoints evaluating the extent and severity of the disease.
Analyst Joseph Pantginis commented today,
We are impressed by the results of the Phase III trial of Dupixent for use in atopic dermatitis in adult patients and believe that there will be continued success in the upcoming pediatric pivotal studies in 1) patients aged 12-17 expected to start in 1Q17, 2) patients aged 6-11 expected to start in 1H17, and 3) patients aged six months to five years expected to start in 2018. The Dupixent BLA was accepted for Priority Review by the FDA with a PDUFA target date of March 29, 2017. In addition, Dupixent is being evaluated for several other indications including asthma, nasal polyps, and eosinophilic esophagitis (EoE). Currently, the Phase III QUEST trial for use in asthma is fully enrolled and ongoing. The nasal polyp Phase II trial had positive results and a Phase III study is expected to be begin in early 2017. Lastly, a Phase II proof of concept study is underway for EoE.
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Related EntitiesRoth Capital, PDUFA
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