Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) announced the presentation of results from a phase III monotherapy study (SARIL-RA-MONARCH) on their rheumatoid arthritis (RA) candidate, sarilumab. The results were announced at an oral session during the American College of Rheumatology (ACR) Annual Meeting in Washington, D.C. Top line results from the study were announced in March this year.
The study included patients suffering from active RA who responded inadequately to, intolerant of, or were inappropriate for methotrexate treatment. The patients were randomized to receive either a subcutaneous sarilumab monotherapy (200 mg every 2 weeks) or AbbVie Inc.’s (ABBV - Free Report) Humira (adalimumab) monotherapy (40 mg every 2 weeks).
Results revealed that sarilumab is superior to Humira in improving signs and symptoms in patients with active RA at week 24, thereby meeting the primary endpoint of the study. The study also met other important endpoints including an improvement in ACR criteria and other measures assessing improvements in signs and symptoms of RA and physical function.
Moreover, sarilumab, which is an anti interleukin-6 receptor monoclonal antibody, is under FDA review for the treatment of patients suffering from active, moderate-to-severe RA. Regarding this, a Complete Response Letter (CRL) from the FDA was given in October, which identified certain deficiencies during a routine good manufacturing practice inspection of the Sanofi Le Trait facility where sarilumab is filled and finished. Those deficiencies must be addressed before the drug can be approved by the FDA.
While Regeneron is a Zacks Rank #2 (Buy) stock, Sanofi carries a Zacks Rank #3 (Hold). Anika Therapeutics Inc. (ANIK - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted positive surprises in each of the trailing four quarters, with an average beat of 33.14%.Share prices surged 17.1% year to date.
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