OS Therapies Inc. (NYSE:OSTX) announced a statistically significant three-year overall survival benefit for patients treated with OST-HER2 in its Phase 2b trial.
The study evaluated the prevention or delay of recurrence in patients with fully resected, pulmonary metastatic osteosarcoma.
Osteosarcoma is an aggressive type of malignant (cancerous) bone tumor that produces immature bone tissue, known as osteoid.
Phase 2b Survival Data and WHO Approval
The final analysis revealed a 72.7% three-year survival rate for patients receiving the OST-HER2 treatment, compared to 45.8% in a comparable combined historical control group.
Interim data showed a 71.2% overall survival rate at the three-year mark.
Additionally, the World Health Organization accepted the proprietary brand name Herlystic for the therapy.
Following these favorable results, the clinical-stage oncology company plans to finalize submissions for early market access across the U.S., the U.K., Europe, and Australia during the fourth quarter of 2026.
Regulatory Designations And Potential Voucher Sale
OST-HER2 holds multiple regulatory statuses, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA, alongside equivalent European designations.
Under the Rare Pediatric Disease program, securing a Biologics License Application in the U.S. makes the company eligible for a Priority Review Voucher. The company intends to sell this voucher if granted.
A similar voucher sold for $220 million in August 2026, though future valuation remains uncertain.
Furthermore, the FDA accepted the company’s Commissioner’s National Priority Voucher letter of intent, and the company recently resubmitted a Regenerative Medicine Advanced Therapy request.
OSTX Stock Price Activity: OS Therapies shares are trading lower by 2.19% at $1.56 at the time of publication on Tuesday, according to Benzinga Pro data.
Photo courtesy: Billion Photos on Shutterstock.com
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