OS Therapies FDA Meeting Request Granted
OS Therapies Incorporated (OSTX)
Company Research
Source: Business Wire
Written response-only meeting to align analysis plan of surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic OsteosarcomaAnalysis to be featured at keynote presentation closing out major osteosarcoma conference MIB Factor on June 28, 2025 at 3:30pm MDT 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 the US Food & Drug Administration (“FDA”) granted the Company’s meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma. FDA granted a written response-only meeting and confirmed that its response would be received by mid-June 2025, in time for the Company to prese
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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