Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options
Biogen Inc. (BIIB)
Last biogen inc. earnings: 4/22 07:12 am
Check Earnings Report
US:NASDAQ Investor Relations:
biogen.com/en_us/investors.html
Company Research
Source: GlobeNewswire
Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activityLitifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurementFDA Breakthrough Therapy Designation is granted to expedite the development and review of drugs for serious diseases CAMBRIDGE, Mass., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). Litifilimab is a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2). CLE is a chronic aut
Show less
Read more
Impact Snapshot
Event Time:
BIIB
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
BIIB alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
BIIB alerts
High impacting Biogen Inc. news events
Weekly update
A roundup of the hottest topics
BIIB
News
- Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus [Yahoo! Finance]Yahoo! Finance
- Biogen (NASDAQ:BIIB) had its "neutral" rating reaffirmed by analysts at Citigroup Inc..MarketBeat
- FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review [Yahoo! Finance]Yahoo! Finance
- FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority ReviewPR Newswire
- Biogen (NASDAQ:BIIB) had its price target raised by analysts at Wedbush from $143.00 to $178.00. They now have a "neutral" rating on the stock.MarketBeat
BIIB
Earnings
- 10/31/25 - Beat
BIIB
Sec Filings
- 1/14/26 - Form 8-K
- 12/3/25 - Form 4
- 11/13/25 - Form SCHEDULE
- BIIB's page on the SEC website