OS Therapies unit gets USDA feedback on OST-HER2 licensure path for canine osteosarcoma
OSTX•OS Animal Health received USDA feedback on the regulatory path for OST-HER2, covering efficacy, safety, non-clinical requirements and CMC. It targets a 2027 U.S. launch and expects additional studies for full licensure.
1. USDA regulatory feedback
OS Therapies’ animal health unit, OS Animal Health, received USDA feedback on the regulatory pathway for OST-HER2 in canine osteosarcoma. The guidance covered clinical efficacy, safety, non-clinical requirements and CMC ahead of a planned conditional licensure request. The unit targets a 2027 U.S. commercial launch and expects additional studies to support full USDA licensure.
2. Funding and strategic plans
OS Therapies is weighing strategic or capital alternatives to monetize OS Animal Health for shareholder benefit. OS Animal Health plans a Q4 2026 crowdfunding to broaden ownership ahead of a potential U.S. exchange listing.
