Baxalta Rises on FDA Approval

Baxalta Inc. (NYSE: BXLT) was rising in Wednesday’s trading session on news of a key U.S. Food and Drug Administration (FDA) approval. The company received approval for its drug that treats von Willebrand disease, a rare inherited bleeding disorder that results from a missing protein.

The treatment, BAX 111, is a synthetic version of the von Willebrand factor, which is a protein key in the coagulation process. Von Willebrand disease affects 1% of the population, and this injectable therapy is designed to halt the resulting bleeding when used on demand.

The company plans to launch the drug under the brand name Vonvendi, expanding its portfolio of treatments for bleeding disorders, led by the hemophilia treatments Advate and Feiba. In November, Baxalta won FDA approval for Adynovate, a long-acting version of Advate poised to contend with a new therapy from Biogen and in-development products from Bayer and Novo Nordisk.

Baxalta, which was spun out of Baxter this past summer, set a very ambitious goal of launching 20 new products by 2020, with the intent to grow its annual revenue to $8.5 billion in the process.

In the meantime, Baxalta is facing some unwelcome M&A attention from Shire, turning down a $30 billion buyout offer earlier this year. Shire has publicly stated that it is unwilling to give up on the idea of a merger, and reports have surfaced over the past month suggesting the company may come forward with a renewed pitch in the coming weeks.

Shares of Baxalta were trading up 1.2% at $37.42 on Wednesday, with a consensus analyst price target of $42.50 and a 52-week trading range of $29.83 to $40.90.
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