OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program
OS Therapies accepted a meeting request from the FDA's Center for Drug Evaluation and Research to review biomarker data for OST-HER2, scheduled alongside a separate meeting with the Center for Biologics Evaluation and Research to discuss 2.5-year overall survival data. Alignment between these FDA centers facilitates the preparation for a Biologics License Application under the Accelerated Approval Program, which the company expects to submit in early Fall 2026.
Key figures
- Drug Name
- OST-HER2
- Phase Of Trial
- Phase 2b
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.