BIIB Stock: 9 Things to Know About Biogen’s Alzheimer Drug Approval Controversy

Biogen (NASDAQ:BIIB) stock is dipping lower today on the additional controversy surrounding the approval of its Alzheimer’s drug, Aduhelm.

Biogen Factory Building in: Luterbach Solothurn Switzerland

Source: PictureDesignSwiss /

Here’s everything investors need to know about the drug approval controversy and why it’s affecting BIIB stock.

  • Aduhelm is the company’s new Alzheimer’s drug that received accelerated approval from the U.S. Food and Drug Administration (FDA).
  • The drug has been in development for years and at times wasn’t expected to come to market.
  • That includes in March 2019 when the company shelved it due to poor results from a clinical trial.
  • However, it announced later that year that it was seeking approval from the FDA after a larger trial showed positive results.
  • Some experts have been skeptical of those results and that includes members of the FDA’s Peripheral and Central Nervous System Advisory Committee.
  • Since approval for the drug was revealed on Monday, three members of the committee have resigned.
  • The committee didn’t recommend approving the drug but the FDA decided to ignore that advice.
  • Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter already resigned earlier this week.
  • Now, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, has joined them in turning in his resignation.

Dr. Kesselheim had this to say about Aduhelm’s approval in his resignation letter obtained by CNBC.

“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system.”

BIIB stock was down 1% as of Friday morning but is up 68.7% since the start of the year.

Investors that want to get up to speed on other recent medical stock news should keep reading.

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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the Publishing Guidelines.

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