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 Ost...
OS Therapies Incorporated (OSTX)
Company Research
Source: Yahoo! Finance
Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documents FDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have to be underway prior to granting a BLA FDA indicated that the use of canine data to support confirmation that pre-specified immune biomarker activation is correlated with treatment-emergent human clinical benefit will depend on biomarkers chosen for evaluation & clinical validation thereof FDA requested follow-up meeting once immune activation biomarker analysis is available to review data within context of pending Company-planned BLA filing Key Opinion Leader Dr. Peter Anderson, who participated in the meeting following FDA's request that a key opinion leader be present to help educate the agency on the standard o
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OSTX
News
- 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
- OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic Osteosarcoma [Yahoo! Finance]Yahoo! Finance
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