OS Therapies Requests Meeting with FDA to Gain Agreement on Surrogate Endpoint(s) for Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of...
OS Therapies Incorporated (OSTX)
Company Research
Source: Yahoo! Finance
Based on prior FDA guidance, greater than 200 suitable matched lung metastatic osteosarcoma patient records identified from leading oncology centers in the US, UK and France for inclusion in OST-400, a Retrospective Longitudinal Study of Recurrent Osteosarcoma after Resection in Children and Young Adults NEW YORK, April 07, 2025 BUSINESS WIRE )--OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval via a conditional BLA of investigational off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma. The
Show less
Read more
Impact Snapshot
Event Time:
OSTX
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
OSTX 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
OSTX alerts
High impacting OS Therapies Incorporated news events
Weekly update
A roundup of the hottest topics
OSTX
News
- OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma [Yahoo! Finance]Yahoo! Finance
- Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) 3Q25 [Yahoo! Finance]Yahoo! Finance
- OS Therapies to spin off OS Animal Health into a standalone public company [Seeking Alpha]Seeking Alpha
- OS Therapies to Spinoff OS Animal Health into Standalone Public Company [Yahoo! Finance]Yahoo! Finance
- OS Therapies GAAP EPS of -$0.21 misses by $0.08 [Seeking Alpha]Seeking Alpha
OSTX
Earnings
- 11/17/25 - Miss
OSTX
Sec Filings
- 11/14/25 - Form 10-Q
- 10/31/25 - Form S-8
- 10/21/25 - Form 8-K
- OSTX's page on the SEC website