OS Therapies Updates Sequence Of OST-HER2 Regulatory Submissions, Prioritizes UK MHRA MAA Submission

(RTTNews) - OS Therapies issued a regulatory update on its plans for filing marketing authorizations in the United States and United Kingdom for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.

The company has updated its regulatory filing sequence to prioritize the UK Medicines and Healthcare products Regulatory Agency conditional Marketing Authorisation Application final module submission to immediately precede its US FDA Biologics Licensing Application final module submission under the Accelerated Approval Program. The company expects to complete the MHRA conditional MAA submission in December 2025, with the FDA BLA Accelerated Approval submission expected in January 2025. At the direction of FDA, the company has requested an additional Type C meeting to review updated overall survival and new biomarker data.

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