- OS Therapies (OSTX, Financial) received an End of Phase 2 Meeting grant from the FDA for its OST-HER2 program.
- The company plans a Rolling Review process for its Biologics License Application (BLA) submission.
- OST-HER2 has multiple FDA designations, including Orphan Disease and Rare Pediatric Disease.
OS Therapies (OSTX), a biopharmaceutical company specializing in immunotherapy and Antibody Drug Conjugates, has been granted an End of Phase 2 Meeting by the U.S. Food and Drug Administration (FDA) for its OST-HER2 program. This program focuses on preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma. The meeting is slated for the third quarter of 2025, marking a significant step toward market access for the drug.
The company intends to seek FDA alignment to initiate a Rolling Review process for its forthcoming Biologics License Application (BLA) submission for OST-HER2. This process allows OS Therapies to submit completed sections of the BLA as they become available, potentially expediting the FDA approval timeline through enhanced interactions.
OST-HER2 has received several FDA designations, including Orphan Disease, Fast Track, and Rare Pediatric Disease Designations. Notably, under the Rare Pediatric Disease Designation program, OS Therapies could become eligible for a Priority Review Voucher if they receive Accelerated Approval for OST-HER2 before September 30, 2026. These vouchers have considerable market value, with a recent sale in June 2025 fetching $160 million.
In addition to its progress in human treatments, OST-HER2 is featured in the film "Shelter Me: The Cancer Pioneers," highlighting its role in comparative oncology between canines and humans. OS Therapies has established a subsidiary, OS Animal Health, to further develop its canine osteosarcoma program.
OS Therapies operates within the biotechnology sector, focusing on innovative treatments for solid tumors. The firm continues to advance its next-generation Antibody Drug Conjugates, leveraging proprietary technology to enhance drug delivery mechanisms.
