Credit: Shutterstock photoNektar TherapeuticsNKTR and Baxalta Incorporated BXLT announced that complete data from the phase II/III pivotal study and phase I study on hemophilia A candidate, Adynoyate (BAX 855), were published in Blood, the journal of the American Society of Hematology. Adynoyate is an extended half-life recombinant factor VIII (rFVIII), based on Advate, a full-length FVIII molecule.
Data from the study showed a mean half-life extension of 1.4- to-1.5-fold compared with Advate. We note that positive results were first reported in Aug 2014. this was followed by the submission of a regulatory application in Dec 2014 in the U.S. Approval would provide patients with a new treatment option which combines Advate's bleed prevention with a simple, twice-weekly dosing schedule.
Baxalta is also looking to get Adynoyate approved in Japan, where a regulatory application was filled earlier this year.
Meanwhile, Baxalta continues to progress with the Continuation Study in patients with severe hemophilia A, who completed the pivotal trial as well as the pediatric phase III study among previously treated patients under the age of 12 years. The company expects to file for EU approval in 2016, once the pediatric study is completed.
Timely FDA approval would make Adynoyate one of the first treatments out of twenty that Baxalta intends to bring to market by 2020.
While Baxalta is a Zacks Rank #3 (Hold) stock. Nektar carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector are Eleven Biotherapeutics, Inc. EBIO and AMAG Pharmaceuticals, Inc. AMAG each carrying a Zacks Rank #1 (Strong Buy).
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