Aug. 7 at 1:43 PM
OS Therapies (NYSE-A:
$OSTX) reported statistically significant positive 2-year overall survival results from an interim analysis of its Phase 2b trial of its off-the-shelf immunotherapy candidate OST-HER2 for preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma.
OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1.
The company also announced its NYSE American listing has been added to the Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes. FTSE Russell determines membership for its Russell indexes based on objective, market-capitalization rankings, and style attributes. Investment managers and institutional investors widely use Russell indexes for index funds and as benchmarks for active investment strategies.
Highlights from today’s news release include:
- 66.6% of patients treated with OST-HER2 (18/27) reached 2-year overall survival versus 40% in historical controls (p = 0.0046).
- The FDA issued a Biologics License Application (BLA) number for OST-HER2 ahead of the anticipated filing following the pending August 27, 2025, End of Phase 2 Meeting.
- The company is working with the FDA to align metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy Designation (BTD), and BLA through the Accelerated Approval pathway.
Paul Romness, MPH, Chairman & CEO of OS Therapies, remarked, “We are seeking to bring this novel immunotherapy to market to improve the survival rates in pulmonary metastatic osteosarcoma, and today’s updated interim overall survival data continues to show a statistically significant benefit for OST-HER2-treated patients compared with control. We believe that continued statistically significant outperformance in overall survival of OST-HER2 treated patients compared with historical control, together with the statistically significant positive 12-month Event Free Survival data presented at MIB Factor in June 2025, will provide the necessary scientific and medical basis to support a BLA under the FDA’s Accelerated Approval Program.”
Read the full release at: https://ir.ostherapies.com/news-events/press-releases/detail/72/os-therapies-announces-statistically-significant-positive
Led by CEO Paul Romness and an experienced executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers.
Learn more about OS Therapies’ work at https://www.ostherapies.com and visit B2i Digital for updates. For investor-related questions, please see OS Therapies’ Investor Relations page or email
[email protected].
Disclosure: The management of B2i Digital owns unrestricted shares of OSTX stock purchased in the open market. This post is not intended to solicit the sale of OSTX or any security, and it is not intended to offer any opinion on OSTX as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the full disclosure in the Risks and Disclosures section of https://b2idigital.com/os-therapies-1
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