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OS Therapies granted End of Phase 2 Meeting by FDA to review OST-HER2 program
OS Therapies announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration, FDA, to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The Company expects the meeting to occur in the third quarter of 2025. The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access. The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application submission for OST-HER2. The Rolling Review process means that a company can submit completed sections of its Biologic License Application for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. This can contribute to augmented interactions with FDA and potentially an expedited BLA approval timeline.
OS Therapies reports 'positive' results from Phase 2b trial of OST-HER2
OS Therapies announced positive 1-year event free survival, overall survival and safety clinical trial data updates from the 40 patient treatment arm of its Phase 2b clinical trial of immunotherapy candidate OST-HER2 in the prevention or delay of recurrence in fully resected, lung metastatic osteosarcoma. In data presented by Principal Investigator Dr. Damon Reed at the MIB Factor Osteosarcoma Conference held in Salt Lake City, Utah on Saturday June 28, 2025 the following data updates were released: 35% of OST-HER2-treated patients achieved 1-year event free survival compared with 20% of patients from peer-reviewed publication selected by Children's Oncology Group as equivalent to osteosarcoma patient subpopulation enrolled; A total of 13 out of 40 patients were reported to have experienced severe adverse events during the trial, of which 7 patients' adverse events were treatment-associated adverse events. All of the 7 patients' TSAEs were grade 3 TSAEs; 0 patients experienced grade 4 or grade 5 TSAEs. None of the patients for whom TSAEs were reported discontinued the study. "The updated OST-HER2 data presented at MIB Factor that showed EFS data statistically significantly favoring OST-HER2 treated patients when compared with the leading peer-reviewed publications on historical event free survival outcomes in this subset of the pulmonary metastatic osteosarcoma patient population," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "The favorable safety profile of OST-HER2 compared with standard of care is also an important quality of life factor when assessing potential new treatment options for this difficult to treat patient population."
OS Therapies receives feedback from FDA Type D Meeting for OST-HER2 trial
OS Therapies announced that it received written feedback from the FDA Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an accelerated approval program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28. Concurrent with this announcement, the company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company's overall regulatory strategy and timelines.
OS Therapies partners with Eversana for U.S. commercialization of OST-HER2
OS Therapies has selected Eversana, a provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric lung metastatic osteosarcoma. OS Therapies is a clinical-stage cancer immunotherapy company dedicated to developing a new way of activating the immune system to kill cancers that express HER2 like Osteosarcoma, Breast Cancer, Colorectal Cancer and other solid tumors. OST-HER2 is the first potential new treatment in over 40 years for pediatric osteosarcoma, a rare, aggressive bone cancer that often metastasizes to the lungs, primarily affecting children and adolescents. The therapy has received Orphan, Fast Track and Rare Pediatric Disease Designations from the FDA, with a Biologics License Application rolling submission targeted to begin in Q3, with potential approval coming as early as year end 2025.
OS Therapies reports Q1 EPS (18c), consensus (8c)
Reports Q1 net operating loss $3.876M vs. $1.490M last year. "The Q1 was a crucial execution quarter for OS Therapies, as we announced positive data from our OST-HER2 Phase 2b clinical trial in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma and will be leveraging this data to seek Accelerated Approval from the FDA and other regulatory authorities," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "Additionally, we consolidated ownership of the listeria immunotherapy platform, adding three clinical stage and eight preclinical assets to our pipeline. We extended the exclusivity protection for its commercial runway into 2040 with the issuance of a new manufacturing patent. Additionally, we have secured research coverage from Wall Street analysts who have shown significant interest in the revival of the listeria immunotherapy platform. We have started important interactions with the FDA with a view towards an Accelerated Approval, with the Osteosarcoma community supporting in the ongoing FDA process. We believe we are well positioned to bring the first new treatment for osteosarcoma to market in over 40 years."
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