OS Therapies Inc. (NYSE-A: OSTX) Makes Important Strides in Rare Cancer Therapy

July 14, 2025 at 10:00 AM EDT

The global oncology drug market is currently valued at over 200 billion dollars and is expected to more than double to 532 billion dollars by 2031. This growth is driven not only by rising demand but also by genuine innovation. After years of steady but incremental progress, newer therapies such as antibody drug conjugates and immunotherapies are making real headway against some of oncology’s toughest challenges, including rare pediatric cancers, relapsed tumors, and diseases like osteosarcoma, where survival rates have remained largely stagnant.

Regulatory agencies are accelerating these advances with tools like Fast Track and Accelerated Approval. At the same time, comparative oncology, which leverages naturally occurring canine cancers to generate more clinically relevant data, is creating fresh opportunities for development. This convergence makes the current moment especially promising for investors focused on oncology innovation.

One company leading in this space is OS Therapies (NYSE-A: OSTX), a clinical-stage biopharmaceutical firm advancing immunotherapies and precision oncology platforms. Its lead candidate, OST HER2, has shown statistically significant survival benefits in patients with recurrent fully resected lung metastatic osteosarcoma, a population with very limited treatment options and poor historical outcomes. With regulatory engagement progressing in both the United States and Europe, OSTX could be poised for a potential breakout.

Breakthrough Potential in Osteosarcoma

OS Therapies (NYSE-A: OSTX) is advancing OST-HER2, a novel immunotherapy designed to activate the immune system against HER2-expressing cancer cells using a bioengineered form of Listeria monocytogenes. The company recently released compelling Phase 2b data for patients with recurrent, fully resected lung metastatic osteosarcoma, a population with limited options and poor historical outcomes.

Among the 40 patients treated with OST-HER2, 35 percent achieved one-year event-free survival, compared with 20 percent in a peer-reviewed historical control group. The p-value of 0.0194 suggests the result is statistically significant. Just as important, no patients experienced grade four or grade five treatment-associated adverse events, indicating a favorable safety profile.

“The updated OST-HER2 data presented at MIB Factor showed EFS data statistically significantly favoring OST-HER2-treated patients,” said Dr. Robert Petit, Chief Medical and Scientific Officer. “The favorable safety profile compared with the standard of care is also an important quality of life factor for this difficult-to-treat population.”

Regulatory Tailwinds and PRV Potential

Momentum with regulators has been steadily building. The U.S. Food and Drug Administration has scheduled an End of Phase 2 meeting with OS Therapies for August 27, 2025. There, the company will seek agreement to initiate a rolling Biologics License Application submission. Should that process move forward, OST-HER2 may become eligible for accelerated approval.

OST-HER2 already holds several valuable FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease. If the therapy is approved before September 30, 2026, OSTX will be eligible to receive a Priority Review Voucher, which the company intends to sell. The last PRV transaction in June 2025 brought in $160 million.

“We are making significant progress toward our primary objective of obtaining regulatory approval for OST-HER2 prior to the sunsetting of the PRV program,” said Chairman and CEO Paul Romness. “If successful, we expect to receive significant non-dilutive funding from the sale of the PRV, which we would then deploy in commercializing OST-HER2 and advancing other clinical candidates in our pipeline.”

Global Strategy and Pipeline Expansion

International efforts are also underway. OS Therapies has confirmed Scientific Advice Meetings with regulators in the United Kingdom and European Union, with plans to seek Conditional Marketing Authorization in both regions. In the UK, the company has secured access to the Clinical Practice Research Datalink, which could support real-world data submissions. It is also pursuing review through the European Medicines Agency’s centralized procedure.

Beyond osteosarcoma, OSTX is preparing for data from a Phase 1 study of OST-504, a listeria-based immunotherapy for prostate cancer. All patients in that study have completed treatment, and results are expected later this year. The company is also advancing its tunable antibody drug conjugate platform, built around proprietary Si-Linker and Conditionally Active Payload technologies that aim to improve therapeutic precision.

To support long-term growth, OS Therapies recently acquired several clinical and preclinical immunotherapy assets and was granted a new manufacturing patent tied to its listeria platform. These moves extend its intellectual property runway into 2040. The company has also formed two new subsidiaries, OS Animal Health and OS Drug Conjugates, to explore commercial applications in comparative oncology and targeted therapeutics.

Final Word

With statistically significant survival data, multiple regulatory designations, and a lead program approaching a key FDA meeting, OS Therapies (NYSE: OSTX) is positioned for a major inflection point. If OST-HER2 secures accelerated approval and qualifies for a Priority Review Voucher, the company could unlock meaningful non-dilutive funding. Between the late-stage momentum in osteosarcoma and a growing pipeline of immunotherapy and ADC programs, OSTX offers investors early exposure to a potential new leader in precision oncology.

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OS Therapies Inc. (NYSE-A: OSTX) Makes Important Strides in Rare Cancer Therapy

Breakthrough Potential in Osteosarcoma

Regulatory Tailwinds and PRV Potential

Global Strategy and Pipeline Expansion

Final Word

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