Biogen inches closer to FDA approval for its Alzheimer’s drug

Shares of Biogen Inc (NASDAQ: BIIB) gained nearly 10% in extended hours after the biotech firm edged closer to winning FDA approval for its Alzheimer’s drug.

FDA panel greenlights Biogen’s Leqembi

Late on Friday, advisory committee of the U.S. Food and Drug Administration unanimously recommended Leqembi for the treatment of Alzheimer’s disease.

Biogen makes that drug in collaboration with Eisai Co. On CNBC’s “Closing Bell: Overtime”, Matter Herper of Stat News said:

It’s very important, but it was also largely expected. It’s pretty much the outcome that most people on Wall Street and most researchers have been expecting.

The news arrives more than a month after Biogen reported better-than-expected results for its first financial quarter. Its shares are up more than 20% versus the start of the year at writing.

Leqembi could get FDA approval by July 6^th

Remember that the FDA usually does but is not bound to follow what the committee recommends. The federal agency is expected to announce its decision on Leqembi by July 6^th.

It is also noteworthy here that rival Eli Lilly & Co (NYSE: LLY) has its own Alzheimer’s drug (Donanemab) set for later this year. According to Stat News’ Herper:

It’ll be a slower market to build. This is a step along the way of getting Medicare coverage. Medicate will start off requiring patients go into a database that may slow things down initially.

Nonetheless, experts believe the market for Alzheimer’s drugs to be worth about $13 billion by the end of this decade. Wall Street currently has a consensus “overweight” rating on the biotech stock Biogen.

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