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: Business Wire
OS Therapies applies for meeting per FDA suggestion received on April 2, 2025 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--(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
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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