
OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance
Newsfile Corp
Published: Sep 02, 2026, 11:20 AM
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Management will participate at Jefferies Global Healthcare Conference, H.C. Wainwright Global Investment Conference, ROTH Healthcare Opportunities Conference Management and business development advisors will attend BioJapan Interim 3-year overall survival data, U.S. FDA Type C Statistical Methods meeting and U.K. MHRA Statistical Methods Scientific Advice Meeting expected in September 2026 RMAT and Rolling Review decisions expected to follow U.S. FDA meeting Final 3-year overall survival data, U.S. FDA Pre-BLA Meeting, BLA submission, MHRA CMAA submission, and EMA CMAA submission expected in Q4 2026 Confirmatory Phase 3 Clinical Trial Application to follow MHRA meeting for Q4 2026 trial commencement OS Animal Health to attend Moody Capital Disruptive Growth & Life Sciences Conference New York and Rockville, Maryland--(Newsfile Corp. - September 2, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company") , the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that its management team, its business development advisors and the management team of its wholly-owned subsidiary OS Animal Health will participate in upcoming conferences, and provided a program update for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program"): Jefferies Global Healthcare Conference: London - November 16-19, 2026 H.C. Wainwright Global Investment Conference: New York - September 14-16, 2026 ROTH Healthcare Opportunities Conference: New York - September 29, 2026 BioJapan: Yokohama, Japan - October 7-9, 2026 Moody Capital Disruptive Growth & Life Sciences: New York - September 9-10, 2026 OS Therapies management is scheduled to host one-on-one meetings with investors and strategic partnering attendees during these conferences. Investors and strategic partners interested in arranging one-on-one meetings should contact their respective institutional representative or the Company. OS Therapies may attend additional investor, medical, scientific, partnering, or conferences in addition to the above. OST-HER2 Pulmonary Metastatic Osteosarcoma Program Update "We have reached a pivotal moment in the history of OS Therapies," said Paul Romness, MPH, Chairman and CEO of OS Therapies. "The coming months are expected to define our path as a company as we look to translate the over 20 years and $300 million of investment in our listeria monocytogenes cancer immunotherapy platform into its first commercial product that we expect to reach patients in 2027. Following regulatory interactions expected throughout the month of September 2026 with the U.S. Food & Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), we expect to submit regulatory approval requests for early market access in the U.S., U.K., Europe and Australia. We expect minutes from both the FDA Type C Statistical Methods Meeting and the MHRA Statistical Methods Scientific Advice Meeting in October 2026. Additional rounds of regulatory meetings are expected throughout the rest of the fourth quarter of 2026, followed by FDA, MHRA and EMA regulatory decisions." OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA, and ODD, FTD and ATMP from the EMA. Under the RPDD program, if the Company receives a BLA in the United States, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale occurred in August 2026 for $220 million . However, there can be no assurance that the Company would realize a comparable value, if any, in connection with any future PRV sale. OS Therapies has completed resubmission of a Regenerative Medicine Advanced Therapy (RMAT) request and the Company's Commissioner's National Priority Review Voucher (CNPV) letter...
Source: Newsfile Corp
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