OS Therapies Hires Dr. Craig Eagle, Sets Q2 FDA and MHRA Meetings for OST-HER2 BLA
OS Therapies named Dr. Craig Eagle, former Guardant Health CMO, as Chief Medical Advisor to bolster medical, regulatory, and commercial strategy ahead of OST-HER2 early market access filings in the U.S., U.K., Europe, and Australia. The company has scheduled Q2 FDA and MHRA meetings to align on its confirmatory Phase 3 protocol and Pre-BLA seroconversion biomarker endpoints for the Phase 2b Metastatic Osteosarcoma Program.
1. Leadership Appointment
OS Therapies has appointed Dr. Craig Eagle as Chief Medical Advisor. Eagle brings over two decades of oncology leadership, most recently serving as Chief Medical Officer at Guardant Health and earlier holding senior roles at Genentech and Pfizer, to guide medical, regulatory and commercial strategy.
2. Regulatory Milestones
The company completed key meetings with EMA and ATGA in Q2 and has scheduled FDA and MHRA meetings in the second half of Q2. These sessions will focus on finalizing the confirmatory Phase 3 protocol design and aligning on seroconversion biomarker endpoints for the Pre-BLA submission under the Accelerated Approval program.
3. Commercial and Reimbursement Preparations
Parallel to regulatory engagements, OS Therapies is advancing commercialization and reimbursement planning across the U.S., U.K., Europe and Australia. Discussions with potential partners are ongoing to support market launch assumptions for OST-HER2 in metastatic osteosarcoma.
4. OST-HER2 Program Status and Designations
OST-HER2 holds Orphan Drug, Fast Track and Rare Pediatric Disease designations from FDA and ATMP designation from EMA and MHRA. Positive Phase 2b data in fully resected, pulmonary metastatic osteosarcoma underpin the BLA strategy, with potential Priority Review Voucher eligibility upon approval.