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

on Jun 10, 2023
  • FDA panel recommends Biogen's Leqembi for approval.
  • Pro discussed the news on CNBC's "Closing Bell: Overtime".
  • Biogen stock gained nearly 10% in after-hours trading.

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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

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

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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.

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Leqembi could get FDA approval by July 6th

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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 6th.

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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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