Regulators Approve Updated Phase 3 Trial Design for Edesa Biotech’s ARDS Drug
Edesa Biotech, Inc. - Common Shares (EDSA)
Company Research
Source: Accesswire
TORONTO, ON / ACCESSWIRE / October 25, 2023 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that Health Canada has approved the company's proposal to harmonize clinical trial designs in the U.S. and Canada for an ongoing Phase 3 study of EB05 (paridiprubart). Edesa's monoclonal antibody is currently being evaluated as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related.The harmonized protocol calls for treatment of approximately 600 ARDS subjects hospitalized with SARS-CoV2 infections who are on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation (ECMO). The primary endpoint is the mortality rate at 28 days. The amended study design replaces th
Show less
Read more
Impact Snapshot
Event Time:
EDSA
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
EDSA 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
EDSA alerts
High impacting Edesa Biotech, Inc. - Common Shares news events
Weekly update
A roundup of the hottest topics
EDSA
News
- Edesa Biotech GAAP EPS of -$1.27 beats by $0.51 [Seeking Alpha]Seeking Alpha
- Edesa Biotech Reports Fiscal Year 2025 Results [Canadian Business Journal (Canada)]Canadian Business Journal
- Edesa Biotech Reports Fiscal Year 2025 ResultsGlobeNewswire
- Edesa Biotech (NASDAQ:EDSA) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Edesa Biotech (NASDAQ:EDSA) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $5.00 price target on the stock.MarketBeat
EDSA
Analyst Actions
- 11/3/25 - HC Wainwright
EDSA
Sec Filings
- 12/12/25 - Form 8-K
- 12/12/25 - Form 424B5
- 12/12/25 - Form 10-K
- EDSA's page on the SEC website