Bulletin
Investor Alert

Market Pulse Archives

July 9, 2021, 1:36 p.m. EDT

Biogen shares fall on report FDA head seeking investigation of her agency's approval of Alzheimer's drug

new
Watchlist Relevance
LEARN MORE

Want to see how this story relates to your watchlist?

Just add items to create a watchlist now:

  • X
    Biogen Inc. (BIIB)
  • X
    SPDR S&P Biotech ETF (XBI)
  • X
    S&P 500 Index (SPX)

or Cancel Already have a watchlist? Log In

By Ciara Linnane

Biogen Inc. shares /zigman2/quotes/201531540/composite BIIB -2.89% slid 3% Friday, after a STAT report that the acting head of the U.S. Food and Drug Administration is calling for a federal investigation into her own agency's approval of a treatment for Alzheimer's disease, a month after the decision irked lawmakers, doctors and pubic health advocates and led members of an independent committee associated with the FDA to step down. In a letter, Acting Commissioner Janet Woodcock asked the Office of the Inspector General to investigate interactions between FDA staff and Biogen in the run-up to the approval of the drug Aduhelm, STAT reported. The agency cited reporting by STAT that said FDA officials had worked closely with Biogen to get the drug to market. "There continue to be concerns raised ... regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process," Woodcock wrote in a letter to acting Inspector General Christi Grimm. On Thursday, Biogen announced an updated label for Aduhelm that limited the patients who qualify for the drug to those with "mild cognitive impairment or mild dementia stage of disease" rather than a broader group of people diagnosed with dementia because that is the group of people who were studied in the clinical trials. The FDA has been criticized for approving Aduhelm with what some consider is questionable clinical data and Biogen for how the drug is priced, at $56,000 for a year of treatment. Biogen shares have gained 47% in the year to date, while the SPDR S&P Biotech ETF /zigman2/quotes/205950134/composite XBI -2.72% has fallen 5% and the S&P 500 /zigman2/quotes/210599714/realtime SPX -2.27% has gained 15%.

/zigman2/quotes/201531540/composite
US : U.S.: Nasdaq
$ 242.90
-7.23 -2.89%
Volume: 1.30M
Nov. 26, 2021 1:00p
P/E Ratio
23.77
Dividend Yield
N/A
Market Cap
$36.74 billion
Rev. per Employee
$1.36M
loading...
/zigman2/quotes/205950134/composite
US : U.S.: NYSE Arca
$ 116.78
-3.27 -2.72%
Volume: 7.78M
Nov. 26, 2021 1:10p
loading...
/zigman2/quotes/210599714/realtime
US : S&P US
4,594.62
-106.84 -2.27%
Volume: 2.10B
Nov. 26, 2021 2:12p
loading...

This Story has 0 Comments
Be the first to comment
More News In
Industries

Story Conversation

Commenting FAQs »

Partner Center

Link to MarketWatch's Slice.