OS Therapies secures EMA ATMP designation for OST-HER2, opening conditional EU approval
OS Therapies received EMA ATMP designation for OST-HER2 to treat pulmonary recurrence in resected osteosarcoma, unlocking the Conditional Marketing Authorisation accelerated pathway, reduced SME user fees and tailored CAT review. The company is preparing a CMA submission targeting 2027 revenue and coordinating regulatory dossiers with EU, UK and US agencies.
1. EMA ATMP Designation Details
OS Therapies’ OST-HER2 has been granted Advanced Therapy Medicinal Product designation by the EMA’s Committee for Advanced Therapies for pulmonary recurrence in resected osteosarcoma. This status is equivalent to the FDA’s RMAT designation and confirms OST-HER2’s priority status within Europe’s regulatory framework.
2. Regulatory Pathway and Timelines
ATMP designation opens the Conditional Marketing Authorisation accelerated pathway, reduces SME user fees and enables tailored assessment under CAT. The company is finalizing its CMA submission and will deliver regulatory dossiers to EMA, MHRA and FDA in the coming weeks, with anticipated meetings to review clinical, biomarker and manufacturing data.
3. Financial and Commercial Implications
OS Therapies projects OST-HER2 conditional marketing authorisation by year-end and expects to generate revenues beginning in 2027. The therapy also holds orphan, Fast Track and Rare Pediatric Disease designations in the US and EU, positioning the company to secure a Priority Review Voucher valued at over $200 million upon BLA approval.