Business
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
Conference call scheduled for Thursday, April 30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes validating the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic.EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical efficacy endpoint for...
About this update from Os Therapies Incorporated
[{"type":"text","content":"Conference call scheduled for Thursday, April 30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes validating the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic.","length":381,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical efficacy endpoint for Conditional Marketing Authorizations (CMAs), with alignment also achieved on confirmatory Phase 3 initiation, initially only in Australia, planned for Q3 2026 to meet regulatory requirement to support early approvals in the U.S., U.K., Europe and Australia ","length":367,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alignment achieved with EMA and ATGA on Seroconversion data serving as surrogate clinical efficacy data to support CMAs for early market access and eligibility for a Priority Review Voucher (PRV) under Rare Pediatric Disease Designation (RPDD)","length":243,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alignment achieved with EMA and ATGA on non-clinical, CMC and safety data","length":73,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alignment achieved with ATGA on existing drug product being used to initiate Phase 3","length":84,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"EMA selects Company into Raw Data Pilot Program","length":47,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"OST-HER2 granted ATMP designation by U.K. MHRA","length":46,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company forecasts European peak OST-HER2 osteosarcoma sales exceeding $300 million following ATMP designation grant, with over $50 million in sales expected in 2027 ","length":164,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Upcoming U.S. FDA and U.K MHRA meetings scheduled in 2nd quarter of 2026 ","length":72,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"OST-504 Phase 1b castrate resistant prostate cancer trial biomarker analysis to mirror OST-HER2 Phase 2b osteosarcoma biomarker analysis ","length":136,"tagName":"p","attribs"...