OS Therapies Plans Q1 2026 EU, UK MAA Filings and BLA Module Submission
OS Therapies will submit conditional MAAs to MHRA and EMA by end of Q1 2026, and plans to file its BLA module with the FDA after a Type D meeting in March. Additional biomarker data from its Metastatic Osteosarcoma Program will arrive in Q1 to support surrogate endpoints.
1. Q1 2026 MAA Submissions
OS Therapies expects to submit conditional Marketing Authorization Applications to both the U.K. MHRA and the EMA by end of Q1 2026. These filings target approval of OST-HER2 for osteosarcoma treatment.
2. FDA BLA Module Timeline
Following a Type D meeting slated for March, the company plans to file its Clinical BLA module with the FDA, marking a key U.S. regulatory step for OST-HER2. This module will compile clinical safety and efficacy data.
3. Biomarker Data Release
In Q1 2026, OS Therapies will release additional biomarker data from its Human Metastatic Osteosarcoma Program to characterize immune pathway activation and assess biomarker expression correlation with clinical outcomes. These surrogate endpoints could accelerate efficacy evaluations.
4. Ayala Pharmaceuticals Dissolution
Ayala Pharmaceuticals has completed its dissolution and liquidated all OS Therapies shares, having transferred listeria-based assets to OS Therapies in April 2025 via issuance of 4.8 million shares. Ayala no longer holds any securities in OS Therapies.