Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
Last astrazeneca plc - american depositary shares earnings: 2/5 04:00 pm
Check Earnings Report
US:NYSE Investor Relations:
astrazeneca.com/investor-relations.html
Company Research
Source: Yahoo! Finance
BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 BUSINESS WIRE )--The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE: 4568) and Merck's (known as MSD outside of the United States and Canada) (NYSE: MRK) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The CRL results from findings pertaining to an inspection of a third-party manufacturing facility. The CRL did not identify any issues with the efficacy or safety data submitted. Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck. "We will work closely with the FDA and the third-party ma
Show less
Read more
Impact Snapshot
Event Time:
AZN
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
AZN 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
AZN alerts
High impacting AstraZeneca PLC - American Depositary Shares news events
Weekly update
A roundup of the hottest topics
AZN
News
- O'Shaughnessy Ventures Awards $100,000 Fellowship Grant to Biotech Entrepreneur Aiming to Revolutionize Microbiome Health Monitoring [Yahoo! Finance]Yahoo! Finance
- Systemic Sclerosis Market to Exhibit Significant Growth by 2034, Predicts DelveInsight | Key Companies - Kyowa Hakko Kirin, AstraZeneca, Mitsubishi Tanabe Pharma, Genentech, Amgen, GlaxoSmithKline, Boehringer Ingelheim [Yahoo! Finance]Yahoo! Finance
- Tanium Wins Coveted Microsoft Independent Software Vendor Innovation Partner of the Year Award [Yahoo! Finance]Yahoo! Finance
- AstraZeneca's (AZN) Imfinzi Meets Study Goal in Bladder Cancer [Yahoo! Finance]Yahoo! Finance
- Impact and implications of the $35 monthly price cap on asthma inhalers [Yahoo! Finance]Yahoo! Finance
AZN
Sec Filings
- 6/26/24 - Form 11-K
- 6/25/24 - Form 6-K
- 6/25/24 - Form 6-K
- AZN's page on the SEC website