OS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma
75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs. 60%, p = 0.034) Updated clinical efficacy data being added to regulatory dossiers as Company seeks early market authorizations in U.S., U.K., Europe and Australia in 2nd half of 2026 EMA and Australia TGA (TGA) alignment achieved on early Q4-2026 3-year overall survival data, supported by biomarker data, as key approvable...
2026-06-02 6:00 AM EDT
OS Therapies Announces the Publication of Four Articles on OST-HER2 and Osteosarcoma in Drug Discovery World
New York and Rockville, Maryland--(Newsfile Corp. - May 29, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced the publication of four articles related to OST-HER2 and/or Osteosarcoma in Drug Discovery World. Looking back to see forw
2026-05-29 7:20 AM EDT
OS Therapies to Attend Upcoming Medical, Financial and Industry Conferences
New York and Rockville, Maryland--(Newsfile Corp. - May 26, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will attend upcoming medical, financial and scientific conferences: American Society
2026-05-26 7:40 AM EDT
OS Therapies Reports First Quarter 2026 Financials and Provides Business Update
$5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027 $4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026 Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional...
2026-05-18 6:30 AM EDT
OS Therapies to Announce First Quarter 2026 Financials on Monday, May 18, 2026
New York and Rockville, Maryland--(Newsfile Corp. - May 15, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will announce first quarter 2026 financials and provide a business update on the morning of Monday May 18, 2026. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments...
2026-05-15 4:05 PM EDT
OS Therapies Appoints Industry Leader Dr. Craig Eagle as Chief Medical Advisor
New York and Rockville, Maryland--(Newsfile Corp. - May 14, 2026) - OS Therapies, Inc. (NYSE American
2026-05-14 7:30 AM EDT
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...
2026-04-30 6:00 AM EDT
OS Therapies Schedules OST-HER2 Pharmacodynamic Response Biomarker Conference Call on April 30, 2026 at 8:30am ET
New York, New York--(Newsfile Corp. - April 27, 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 it will be hosting a conference call on Thursday April 30, 2026 at 8:30am ET to review the data that supported the recent Patent Cooperation Treaty (PCT) international application for a
2026-04-27 4:01 PM EDT
OS Therapies Files New Patent Application Covering Biomarkers of the Immune Response to Listeria Monocytogenes
New York, New York--(Newsfile Cor
2026-04-16 7:20 AM EDT
OS Therapies Appoints Biotech Industry Luminary Robert "Bob" S. Langer, PhD as Strategic Advisor
New York, New York--(Newsfile Corp. - April 13, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced today that Dr. Robert "Bob" S. Langer, co-founder of Moderna, was appointed to the Company's s
2026-04-13 6:00 AM EDT
OS Therapies Appoints Craig Eagle, MD as Strategic Advisor
New York, New York--(Newsfile Corp. - April 8, 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 Craig Eagle, MD, was appointed to the Company's newly-formed strategic advisory board. The Company's strategic advisory board is being formed to assist the Company in fine-tuning its osteosarcoma regulatory executio
2026-04-08 11:38 AM EDT
OS Therapies Completes $5.25M Registered Direct Offering Primarily with Pre-Existing High-Net-Worth Investors
New York, New York--(Newsfile Corp. - April 2, 2026) - OS Thera
2026-04-02 5:15 PM EDT
OS Therapies Completes Submission of Biomarker & Clinical Data for U.S. FDA Pre-BLA Meeting, Reports Full Year 2025 Financial Results and Provides Business Update
New York, New York--(Newsfile C
2026-03-31 7:40 AM EDT
OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has been granted meetings with the U.S. Food
2026-03-27 6:00 AM EDT
OS Therapies Granted EMA's Advanced Therapy Medicinal Product (ATMP) Designation for OST-HER2 in the Treatment of Pulmonary Recurrence in Resected Osteosarcoma
New York, New York--(Newsfile Corp. - March 25, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) granted OST-HER2 Advanced Therapy Medicinal Product designation (ATM
2026-03-25 6:00 AM EDT
OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting
New York, New York--(Newsfile Corp. - March 9, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided an update regarding ongoing conversations with the United States Food & Drug Administration (FDA) with regards to its ongoing Biologics License Application (BLA) submission under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in the prevention or delay of recurrent,...
2026-03-09 7:40 AM EDT
OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
New York, New York--(Newsfile Corp. - February 17, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided a global regulatory update for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic o
2026-02-17 6:00 AM EST
OS Therapies Applauds Reauthorization of Pediatric Priority Review Voucher Program to Advance Breakthrough Osteosarcoma Immunotherapies
New York, New York--(Newsfile Corp. - February 4, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, is honored to celebrate the passage of the Mikaela Naylon Give Kids A Chance Act. Mikaela, like so many other children, courageously battled pediatric cancer - specifically Osteosarcoma. Her legacy through this legislation will accelerate critical opportunities for research and therapeutic access for...
2026-02-04 12:45 PM EST
OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Request for FDA Rolling Review submitted to FDA on January 30, 2026 Non-Clinical and CMC BLA modules submitted to FDA At FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in canines Final BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting Regenerative Medicine Advanced Therapy (RMAT)...
2026-02-02 6:00 AM EST
OS Therapies Announces Positive Biomarker Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - January 15, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced positive b
2026-01-15 7:00 AM EST