FDA Accepts OS Therapies Meeting Request For OST-HER2 In Lung Metastatic Osteosarcoma Treatment

(RTTNews) - OS Therapies Inc. (OSTX), Tuesday announced that the US Food & Drug Administration has granted the company's meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma.

In a written response, the agency confirmed that its response would be received by mid-June 2025, in time for the company to present the statistical analysis in a major osteosarcoma conference MIB Factor on June 28.

The company further assured that it is on track for an early third quarter submission, and expects to receive approval by year-end 2025. It aims to make the treatment available for patients in early 2026.

The company noted that OST-HER2 has already received Rare Pediatric Disease Designation for osteosarcoma, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher.

In the pre-market hours, OSTX is trading at $1.55, up 4.02 on the New York Stock Exchange American.