OS Therapies accepts FDA meeting to review biomarker data
OS Therapies accepted an FDA CDER meeting to review pharmacodynamic biomarker data for OST-HER2, supplementing a scheduled CBER meeting on survival data. The company maintains its timeline to start the Phase 3 study near the end of Q3 2026, pending regulatory alignment in the U.S., Europe, and Australia.
*this image is generated using AI for illustrative purposes only.
OS Therapies, Inc. (NYSE: OSTX) has accepted a new meeting request from the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) to review its pharmacodynamic response biomarker data for OST-HER2. This review is part of the FDA's Biomarker Qualification Program (BQP). The meeting is in addition to the previously scheduled Type B Statistical Methods meeting with the Center for Biologics Evaluation and Research (CBER), which will review 2.5-year overall survival data. CBER is the regulatory agency responsible for the approval decision on OST-HER2.
OS Therapies continues to expect the confirmatory Phase 3 clinical study for OST-HER2 to initiate near the end of the third quarter of 2026. The study will launch first in Australia, with expansion to the U.K., Europe, and the United States subject to early market access decisions. The European Medicines Agency (EMA) has set a submission window of September 30, 2026, for Conditional Marketing Authorisation Applications (CMAAs).
Regulatory alignment has been achieved with the EMA, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), and Australia's Therapeutic Goods Administration (TGA) on non-clinical, Chemistry, Manufacturing and Controls (CMC), and clinical safety requirements. The MHRA and TGA have agreed to allow the Phase 3 study to use the same OST-HER2 drug product batch from the Phase 2b trial. In the United States, the company has completed the submission of non-clinical and clinical Biologics License Application (BLA) modules as of January 2026.
| Milestone | Detail |
|---|---|
| Phase 3 Start | Near end of Q3 2026 |
| EMA CMAA Window | September 30, 2026 |
| USDA Meeting | Summer of 2026 |
| First LOC Repayment | April 2, 2027 |
The company has secured a $10 million line of credit supported by VAT reimbursements and R&D Tax Credits. A first draw of $1.6 million was received on July 2, 2026, with repayment due by April 2, 2027. OS Therapies holds $5.6 million in outstanding combined VAT and R&D Tax Credits, with an additional $4.6 million expected by year-end 2026. The company anticipates spending $1 million to open the Phase 3 program in Australia.
OS Animal Health, Inc. (OSAH) recently published peer-reviewed data indicating OST-HER2 combined with radiation improved survival in canine osteosarcoma. OSAH confidentially filed a registration statement on Form S-1 in January 2026 to support a 'go-public' strategy. The company plans to grant shares of OSAH to OS Therapies shareholders and launch a crowdfunding round following a regulatory meeting with the U.S. Department of Agriculture (USDA) in the summer of 2026.
How will the outcomes of the separate CDER and CBER meetings influence the overall regulatory strategy and timeline for OST-HER2?
What specific factors will determine the timing of the study expansion from Australia to the U.S., U.K., and Europe?
Does the company plan to secure additional financing beyond the $10 million line of credit to fund operations through the Phase 3 launch?
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