OS Therapies Schedules United Kingdom’s Medicines and Healthcare products Regulatory Agency's (MHRA) Scientific Advice Meeting in the Third Quarter of 2025 for Review of its OST-HER2 Immun...
OS Therapies Incorporated (OSTX)
Company Research
Source: Business Wire
NEW YORK--(BUSINESS WIRE)--OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2, its immunotherapy candidate for the prevention of recurrence of metastases in osteosarcoma. The Company released positive Phase 2b data in January 2025 that demonstrates statistically significant results in the primary endpoint of the study, 12-month event free survival (EFS). The meeting with MHRA has been scheduled to position the Company to bring OST-HER2 to market in the UK in 2025.“Today’s announcement marks the beginning of the regulatory process required to bring our OST-HER2 immunotherapy to market globally,” stated OS Therapies’ CEO Pa
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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
- 12/19/25 - Form 4
- 12/19/25 - Form 4
- 12/19/25 - Form 4
- OSTX's page on the SEC website