Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) Seeking Approval for Ivonescimab in Combination with Chemotherapy in Treatment of Patients with EGF...
Summit Therapeutics Inc. (SMMT)
Last summit therapeutics inc. earnings: 6/12 07:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
summitplc.com/investors/investor-centre
Company Research
Source: Business Wire
BLA Filing Based on HARMONi Global Phase III Study ResultsPDUFA Goal Action Date of November 14, 2026Significant Unmet Need Remains; Over 14,000 U.S. Patients Eligible for Treatment Each Year in This Setting MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that the U.S. Food & Drug Administration (FDA) has accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.The BLA was submitted based on the overall results of the Phase III HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in p
Show less
Read more
Impact Snapshot
Event Time:
SMMT
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
SMMT 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
SMMT alerts
High impacting Summit Therapeutics Inc. news events
Weekly update
A roundup of the hottest topics
SMMT
News
- Summit Therapeutics (NASDAQ:SMMT) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $40.00 price target on the stock.MarketBeat
- Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
- Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Summit Therapeutics (NASDAQ:SMMT) had its "market outperform" rating reaffirmed by analysts at Citizens Jmp. They now have a $40.00 price target on the stock.MarketBeat
- Summit Therapeutics (NASDAQ:SMMT) had its "market outperform" rating reaffirmed by analysts at Citigroup Inc..MarketBeat
SMMT
Earnings
- 10/20/25 - Beat
SMMT
Sec Filings
- 1/29/26 - Form 8-K
- 1/12/26 - Form 4
- 1/12/26 - Form 8-K
- SMMT's page on the SEC website