OS Therapies Inc. (OSTX) received a fee waiver from the U.S. Food & Drug Administration that eliminates the $1.5 million application fee for its Biologics Licensing Application (BLA) 125867 for the lead product candidate OST‑HER2. The waiver, granted under the accelerated approval pathway, removes a significant upfront cost and accelerates the company’s regulatory timeline.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) granted Union Marketing Authorization eligibility for OST‑HER2 under the Metastatic Osteosarcoma Program. The CHMP has set a deadline of February 28 2026 for OS Therapies to submit an accelerated Marketing Authorization Application, paving the way for a single EU‑wide approval and a potential launch within 12–18 months.
OST‑HER2 is a Listeria‑based immunotherapy that targets the HER2 protein, a strategy that has earned the company Rare Pediatric Disease, Fast‑Track, and Orphan Drug designations in both the U.S. and the EU. The fee waiver is a direct benefit of the orphan status and the company’s small‑business classification, while the EMA eligibility confirms that the product meets the stringent criteria for a centralized procedure in oncology. OS Therapies also completed a pre‑MAA meeting with the UK Medicines and Healthcare products Regulatory Agency on December 8 and has a Type C meeting scheduled with the FDA on December 11.
Chairman and CEO Paul Romness said the regulatory milestones would be “transformative” for the company, noting that the fee waiver and EMA eligibility position OST‑HER2 to move from clinical development into a commercial launch in both the U.S. and Europe. He added that the company’s broader pipeline, which includes a next‑generation antibody‑drug conjugate platform, will benefit from the capital savings and accelerated timelines enabled by the fee waiver.
The osteosarcoma market has remained underserved for more than four decades, and OST‑HER2 represents the first new therapy in that space in a generation. With the FDA fee waiver and EMA eligibility in place, OS Therapies is poised to advance the product through the remaining clinical and regulatory phases, potentially opening a new revenue stream for a disease area that has limited treatment options and a growing patient population. The company’s recent capital raise through warrant exercises will support continued development and the anticipated launch window in the coming 12–18 months.
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