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NEW YORK - OS Therapies (NYSE-A:OSTX), a clinical-stage biotech company with a current market capitalization of $56.67 million, announced Thursday it has been granted an End of Phase 2 Meeting by the U.S. Food and Drug Administration to review its OST-HER2 program for preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma. InvestingPro data shows the stock has shown strong momentum recently, gaining over 5% in the past week, though it remains significantly below its 52-week high of $7.00.
The meeting is expected to take place in the third quarter of 2025, according to the company’s press release statement. OS Therapies plans to seek alignment with the FDA to begin a Rolling Review process for its forthcoming Biologics Licensing Application.
OST-HER2 has received multiple FDA designations including Orphan Disease Designation, Fast Track, and Rare Pediatric Disease Designation. If the company receives Accelerated Approval before September 30, 2026, it would become eligible for a Priority Review Voucher, which it 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 reported positive data in its Phase 2b clinical trial, demonstrating statistically significant benefit in the 12-month event-free survival primary endpoint. While the company is not yet profitable, with an EBITDA of -$11.18 million in the last twelve months, analysts maintain an optimistic outlook with price targets ranging from $6 to $20. InvestingPro subscribers can access 7 additional key insights about OS Therapies’ financial health and growth prospects, along with detailed valuation metrics and peer comparisons.
OS Therapies anticipates submitting its Biologics Licensing Application to the FDA in 2025. The company is also advancing its next-generation Antibody Drug Conjugate platform, which features tunable antibody-linker-payload candidates using proprietary silicone Si-Linker and Conditionally Active Payload technology.
The company has additionally formed a subsidiary called OS Animal Health to advance a canine osteosarcoma program, with OST-HER2 having received conditional approval from the U.S. Department of Agriculture for treating osteosarcoma in dogs.
In other recent news, OS Therapies has reported positive survival data for its immunotherapy candidate, OST-HER2, in treating osteosarcoma. The Phase 2b clinical trial demonstrated a statistically significant improvement in one-year event-free survival, with 35% of patients achieving this milestone compared to 20% in a historical control group. The company has received favorable feedback from the FDA, which could support a future Biologics Licensing Application under the Accelerated Approval Program. OS Therapies has also partnered with EVERSANA to facilitate the U.S. commercialization of OST-HER2, leveraging EVERSANA’s expertise in oncology. Additionally, OS Therapies has sought Regenerative Medicine Advanced Therapy Designation from the FDA, which could expedite the review process for OST-HER2. The company is preparing for a rolling Biologics License Application submission in 2025, aiming for potential approval by the end of that year. OST-HER2 has received several designations from the FDA, including Rare Pediatric Disease, Orphan Drug, and Fast Track. If approved before September 30, 2026, OS Therapies could be eligible for a Priority Review Voucher. The company is also engaging with European and UK regulatory authorities to expand its market access.
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