OS Therapies (OSTX, Financial) announced a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) as it seeks to advance its OST-HER2 treatment for osteosarcoma. The FDA has agreed to a request for a meeting to discuss the use of a surrogate endpoint, a critical step towards obtaining both Breakthrough Therapy Designation and accelerated approval for OST-HER2. This treatment focuses on preventing recurrence in patients with fully resected lung metastatic osteosarcoma.
Instead of a face-to-face meeting, the FDA has opted for a written response-only meeting, with their official feedback expected by mid-June. This timeline positions OS Therapies to incorporate the FDA's insights into the company's statistical analysis, which will be featured in a keynote presentation at the MIB Factor osteosarcoma conference on June 28 at 3:30 PM MDT.
