New York, New York — September 2, 2025 — Leads & Copy — OS Therapies Inc. (NYSE American: OSTX) remains on track to begin a rolling submission of a Biologics Licensing Application (BLA) request to the FDA in September 2025 for its OST-HER2 recurrent, fully resected, pulmonary metastatic osteosarcoma program. This follows a productive End of Phase 2 Meeting with the U.S. Food & Drug Administration (FDA). The company says the FDA has confirmed it is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a final decision expected by the end of Q3 2025. The FDA has also accepted the company’s Expression of Interest for the Commissioner’s National Priority Voucher (CNPV).
According to OS Therapies, the FDA and the Company achieved alignment in crucial areas for a successful BLA, including no significant safety concerns with OST-HER2. Chemistry, Manufacturing, and Controls (CMC)-related matters were agreed to with clear guidance on final steps needed to support a BLA approval. The FDA is also evaluating potential amended clinical trial efficacy endpoints and statistical analysis plans.
A public meeting with key osteosarcoma stakeholders, entitled “Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes,” will be held on October 10, 2025, by the FDA and the Osteosarcoma Institute (OSI).
Luis Rojas, PhD (CEO of InCSD), will present at the Rare Trials Summit in Boston on September 9, 2025. His presentation, entitled “Accelerating Rare Disease Therapies: Strategies for Efficient Clinical Development” will review the key challenges in developing new treatments for ultra-rare diseases.
Paul Romness, MHP, Chair & CEO of OS Therapies, said that it is clear from the End of Phase 2 Meeting that FDA is committed to finding paths forward to bring new therapies forward for osteosarcoma given the continued high mortality rates in this rare pediatric cancer.
Contact Information:
Investor Relations: Harrison Seidner, PhD, WaterSeid Partners, OSTX@waterseid.com
Public Relations: Stephanie Chen, Elev8 New Media, stephanie@elev8newmedia.com
