FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
ROCHE HOLDING LTD S/ADR (RHHBY)
NASDAQ:AMEX Investor Relations:
roche.com/investors.htm
Company Research
Source: Business Wire
– Filing acceptance based on Phase III data showing giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard-of-care endocrine therapy plus everolimus –– Strength of evERA data demonstrate potential for giredestrant combination to help address resistance to standard-of-care therapies, and could be the first and only oral SERD combination approved in the post-CDK4/6 inhibitor setting –– The FDA has set a Prescription Drug User Fee Act date of December 18 – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative
Show less
Read more
Impact Snapshot
Event Time:
RHHBY
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
RHHBY 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
RHHBY alerts
High impacting ROCHE HOLDING LTD S/ADR news events
Weekly update
A roundup of the hottest topics
RHHBY
News
- FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic LeukemiaBusiness Wire
- FDA Accepts New Drug Application for Genentech's Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer [Yahoo! Finance]Yahoo! Finance
- FDA accepts New Drug Application for Roche's giredestrant in ESR1-mutated, ER-positive advanced breast cancer [Yahoo! Finance]Yahoo! Finance
- Flatiron Launches First-of-Its-Kind AI-Powered Global Prostate Cancer DatasetsBusiness Wire
- Roche eyes Gazyva label expansion on positive Phase III kidney disease data [Yahoo! Finance]Yahoo! Finance