OS Therapies granted FDA meeting for OST-HER2

OS Therapies (OSTX) announced that the FDA granted the company’s meeting request to gain alignment on the surrogate endpoint to support breakthrough therapy designation and accelerated approval of OST-HER2 in the prevention of recurrence of fully resected, lung metastatic osteosarcoma. FDA granted a written response-only meeting and confirmed that its response would be received by mid-June, in time for the company to present the statistical analysis as part of the keynote presentation closing out major osteosarcoma conference MIB Factor on June 28 at 3:30pm MDT.