Biogen Gets EU Marketing Approval for MS Treatment Vumerity


The European Commission (EC) has given its green light to Biogen, Inc. (BIIB) to market its multiple sclerosis (MS) treatment Vumerity (diroximel fumarate) in the European Union (EU). The company’s shares closed 3.8% down at $261.55 on Tuesday.

Headquartered in Massachusetts, Biogen is a biopharmaceutical company that engages in the discovery, development, and sale of drugs for the treatment of neurological and neurodegenerative diseases.

About Vumerity

Vumerity is a next-generation fumarate that can be taken by adults orally. It is approved in the U.S., the U.K. and Switzerland to treat adults with relapsing-remitting MS. (See Insiders’ Hot Stocks on TipRanks)

The EC’s approval was based on data from EVOLVE-MS-2 Phase 3 study that compared the gastrointestinal (GI) tolerability of Vumerity and Tecfidera (dimethyl fumarate) in patients with relapsing-remitting MS.

Comments

The Assistant Professor at the Department of Neurology, Ruhr-University Bochum, Simon Faissner, said, “This medication allows for MS patients in the EU to be treated without having to think about dietary restrictions or when to take a dose in relation to mealtimes which, when treating a chronic disease, may provide patients with additional flexibility in their daily lives.”

R&D Head Retires

Meanwhile, Biogen has announced the retirement of Alfred W. Sandrock, Jr., the Head of its Research & Development department, effective December 31.

Sandrock has been the R&D head since October 2019. Additionally, he has served on the company’s Executive Committee since 2015 and as Chief Medical Officer from 2012 to 2020.

Following Sandrock’s departure, Priya Singhal, the Head of Global Safety and Regulatory Sciences, will serve as the Interim Head of Research & Development until a permanent successor is appointed.

Wall Street’s Take

Following the announcement of Sandrock’s retirement, Stifel Nicolaus analyst Paul Matteis said, “While Sandrock’s abrupt departure is of course optically and literally negative, ultimately the prospects for the beaten-down stock continue to come down to the Medicare National Coverage Determination, or NCD, for Aduhelm and the BAN2401 Phase 3 readout due in 2022.”

The analyst has reiterated a Buy rating on the stock with a price target of $344 (31.5% upside potential).

Analyst Recommendation

Overall, the stock has a Moderate Buy consensus rating based on 14 Buys and 7 Holds. The average Biogen price target of $363 implies 38.8% upside potential. Shares have gained 7.7% year-to-date.

Blogger Opinion

TipRanks data shows that financial blogger opinions are 93% Bullish on the stock, compared to the sector average of 69%.

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