OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update [Yahoo! Finance]
OS Therapies Incorporated (OSTX)
Company Research
Source: Yahoo! Finance
following positive August 2025 Scientific Advice Meeting feedback from UK MHRA In principle, UK MHRA accepts use of historical control arm to support conditional MAA UK MHRA conditional MAA and US FDA Biologics Licensing Application (BLA) submissions expected to be completed within 30 days of each other, between December 2025 and January 2026 Company to propose use of immune activation biomarker coupled with overall survival data as surrogate efficacy endpoint to support Accelerated Approval in Type C Meeting invited by FDA, following positive End of Phase 2 Meeting and follow-up interactions New York, New York--(Newsfile Corp. - September 30, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today provided a regulatory update on its plans for filing marketing authorizations in the United States (US) and United Kingdom (UK) for OST-HER2 in the prevention or
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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