$OSTXJul 8, 2026, 1:02 PMAI processed
OSTX accepts FDA meeting to review OST-HER2 biomarker data ahead of BLA
AI Summary
OS Therapies said it accepted a CDER meeting request to review its OST-HER2 pharmacodynamic biomarker data under FDA's BEST program, with the CDER meeting expected in summer 2026 and scheduled to run in parallel with a CBER Type B Statistical Methods meeting reviewing 2.5-year overall survival data. The company provided no new efficacy numbers here, reiterated plans to include final 3-year OS data in a BLA under the Accelerated Approval pathway (targeting late 2026), and noted PRV eligibility if a U.S. BLA is filed and approved.
Positives
- CDER accepted meeting request to review OST-HER2 pharmacodynamic biomarker data under the BEST program
- Parallel scheduling with CBER Type B meeting to review 2.5-year OS data could align biomarker and survival data ahead of BLA
- OST-HER2 has regulatory designations (ODD, FTD, RPDD) that support accelerated pathways and potential PRV eligibility
Negatives
- No new efficacy or survival data disclosed in this announcement
- Meetings and key interim 3-year OS readout are scheduled for summer 2026 — timeline is still distant
- Regulatory alignment and BLA approval remain uncertain and subject to CBER's review