Business

OS Therapies Provides First Half 2026 Corporate Outlook

Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval ProgramBiomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026UK and EU Marketing Authorisation Application...

articleOs Therapies IncorporatedJanuary 5, 20268/company/os-therapies-incorporated/news/os-therapies-provides-first-half-2026-corporate-outlook
OS Therapies Provides First Half 2026 Corporate Outlook

About this update from Os Therapies Incorporated

[{"type":"list","items":[{"val":[{"type":"text","content":"Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval Program","length":292,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Biomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026","length":159,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"UK and EU Marketing Authorisation Application (MAA) submissions for conditional approval expected by end of February 2026 and March 2026, respectively","length":150,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company expects to participate in multiple H1 2026 meetings with U.S. FDA, U.K. MHRA and Europe's EMA as part of processes to gain regulatory approvals","length":155,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"OS Animal Health 'go-public' transaction SEC filing expected in early January 2026","length":90,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Delayed data from OST-504 Phase 1 trial in castration resistant prostate cancer expected in Q1 2026 after prioritizing biomarker lab partner resources for osteosarcoma data analysis, with End of Phase 1 FDA meeting expected in Q2 2026","length":234,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company plans to request End of Phase 2 meeting with FDA to review OST-503 non-small cell lung cancer frontline trial results in combination with Keytruda®","length":155,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":1235,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - January 5, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided stakeholders with a corporate outlook for the first half 2026.","length":288,"tagName":"p"},{"type":"text","content":"The outlook highlights planned submissions to seek regulatory approval for the Company's lead candidate OST-HER2 in the U.S., U.K. and Europe, th...

More updates from Os Therapies Incorporated

The Companyregulatory approvalOS TherapiesFDABiologics License ApplicationosteosarcomaAccelerated Approval Programcancer immunotherapiesregulatory approvalsBiomarker data