OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Osteosarcoma
OS Therapies announced that the EMA has initiated a rolling review of the Conditional Marketing Authorization request for OST-HER2 in osteosarcoma, while the UK MHRA granted Advanced Therapy Medicinal Product designation. Regulatory alignment has been achieved on using 3-year overall survival as the primary efficacy endpoint for confirmatory Phase 3 trials, which are planned to initiate in Q3 2026.
Key figures
- Guidance
- Peak European sales exceeding $300 million; over $50 million in sales expected in 2027
- Vat tax refund gbp
- 1.45 million
- Kras mutation percentage
- 76%
AI analysis
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