Iterum's oral sulopenem acceptance hinges on antibiotic stewardship efforts [Yahoo! Finance]
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
Check Earnings Report
Company Research
Source: Yahoo! Finance
meeting raised concerns about the potential risks of providing an oral antibiotic for uncomplicated urinary tract infections (uUTIs). On September 9, the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) examined Iterum Therapeutics's antibiotic oral sulopenem. Iterum's drug, which is sulopenem etzadroxil combined with probenecid in a bilayer tablet, is a thiopenem antibiotic. If approved, it could become the first oral penem available in the US to treat uUTIs. This was not the first time Iterum's sulopenem reached the regulator. In July 2021, the FDA issued a complete response letter rejecting Iterum's antibiotic due to insufficient evidence of effectiveness in the Phase III uUTI 301 (NCT03354598) and 310 (NCT05584657) trials. In the former study, oral sulopenem demonstrated efficacy in the ciprofloxacin-resistant patient cohort, but it was not effective in the ciprofloxacin-susceptible population, primarily due to microbiologic failure. Similarly, in the 310 study, Iterum's s
Show less
Read more
Impact Snapshot
Event Time:
ITRM
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
ITRM 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
ITRM alerts
High impacting Iterum Therapeutics plc - Ordinary Share news events
Weekly update
A roundup of the hottest topics
ITRM
News
- Iterum Therapeutics Regains Full Nasdaq Compliance [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Regains Full Nasdaq ComplianceGlobeNewswire
- Iterum Therapeutics Reports Third Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Iterum Therapeutics Reports Third Quarter 2024 Financial ResultsGlobeNewswire
- Iterum Therapeutics to Report Third Quarter 2024 Financial Results on November 14, 2024GlobeNewswire
ITRM
Earnings
- 11/14/24 - Miss
ITRM
Analyst Actions
- 9/10/24 - HC Wainwright
ITRM
Sec Filings
- 11/21/24 - Form 8-K
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- ITRM's page on the SEC website