FDA Grants Breakthrough Therapy Designation (BTD) for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
Last urogen pharma ltd earnings: 8/9 08:00 am
Check Earnings Report
US:NASDAQ Investor Relations: investors.urogen.com
UGN-101 Joins Select Group of Urologic Oncology Product Candidates to Receive BTD On Track to Initiate Rolling Submission of UGN-101 New Drug Application (NDA) in Q4 2018 RA’ANANA, Israel & NEW YORK--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for instillation. UGN-101 is currently in Phase 3 development for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Breakthrough Therapy Designation is designed to expedite the development and review of new drugs to treat serious or life-threatening conditions, so patients may have access to t
[Read more]
| Impact snapshot | Event time: | URGN | ||||
|---|---|---|---|---|---|---|
|
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
URGN alerts
URGN alerts
from News Quantified
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
URGN alerts
High impacting UroGen Pharma Ltd news events
Weekly update
A roundup of the hottest topics
URGN
News
- UroGen To Host Investor Day on September 24, 2019 Spotlighting Clinical Development Updates and UGN-101 Launch ReadinessBusiness Wire
- UroGen Pharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- UroGen Pharma Ltd. (URGN) Q2 2019 Earnings Call Transcript [The Motley Fool]The Motley Fool
- UroGen Pharma Ltd. (URGN) CEO Liz Barrett on Q2 2019 Results - Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- UroGen Pharma Reports Second Quarter 2019 Financial Results and Recent Corporate DevelopmentsBusiness Wire
- More
URGN
SEC Filings
- 9/6/19 - Form 4
- 8/22/19 - Form 4
- 8/16/19 - Form 4
- URGN's page on the SEC website
- More