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NEW YORK - OS Therapies (NYSE-A:OSTX), a clinical-stage biotech company with a current market capitalization of approximately $48 million, announced Tuesday it has received positive feedback from the U.S. Food and Drug Administration regarding its Phase 2b trial of OST-HER2, a treatment for pediatric lung metastatic osteosarcoma.
The company has submitted requests for an End of Phase 2 Meeting and Breakthrough Therapy Designation based on the FDA’s feedback from a Type D Meeting held in mid-June. The End of Phase 2 Meeting is expected to take place in the third quarter of 2025. Despite the positive regulatory developments, InvestingPro data shows the stock has declined over 55% in the past six months, though analysts maintain price targets ranging from $6 to $20.
"We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies, according to a press release statement.
The FDA provided input on statistical methods for comparing OST-HER2 treatment with external control arms to support a Biologics Licensing Application through the Accelerated Approval Program.
OST-HER2 has received Rare Pediatric Disease Designation for osteosarcoma from the FDA. If it receives conditional approval via Accelerated Review before September 30, 2026, it will become eligible for a Priority Review Voucher, which the company intends to sell. The most recent such voucher sold for $160 million in June 2025.
The immunotherapy uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger an immune response against HER2-expressing cancer cells. The company’s Phase 2b trial demonstrated statistically significant benefit in the 12-month event-free survival primary endpoint.
OS Therapies anticipates submitting a Biologics Licensing Application to the FDA for OST-HER2 in osteosarcoma in 2025.
The osteosarcoma treatment market was estimated at $1.2 billion in 2022, according to data cited in the company’s announcement. While the company maintains a GOOD financial health score according to InvestingPro analysis, it reported negative EBITDA of $11.2 million in the last twelve months. Subscribers to InvestingPro can access additional financial metrics and 6 more exclusive ProTips about OSTX’s performance and outlook.
In other recent news, OS Therapies Inc. has announced multiple developments regarding its cancer drug OST-HER2. The company has requested the U.S. Food and Drug Administration (FDA) grant Regenerative Medicine Advanced Therapy (RMAT) Designation for OST-HER2, which could expedite its review process. Additionally, OS Therapies has secured a patent extending protection for its Listeria monocytogenes cancer immunotherapy platform until 2040, covering several pipeline candidates, including OST-HER2. The FDA is set to review a surrogate endpoint for OST-HER2, potentially leading to Breakthrough Therapy Designation and Accelerated Approval. OS Therapies has also partnered with EVERSANA to commercialize OST-HER2 in the U.S., leveraging EVERSANA’s integrated commercialization model to enhance market access. Furthermore, the company has received shareholder approval for a significant stock issuance, which could increase financial flexibility. These recent developments underscore OS Therapies’ strategic efforts to advance its pipeline and strengthen its market position.
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