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
OS Therapies Announces Filing Form S-1 of OS Animal Health Subsidiary
OS Animal Health (OSAH), a wholly-owned subsidiary of OS Therapies (OSTX), targeting Initial Public Offering (IPO) on NYSE American or Nasdaq Capital Markets national stock exchange in the first half of 2026 (1H/2026) OSTX shareholders expected to receive one (1) share of OSAH for every ten (10) shares of OSTX owned as of the expected to-be-determined 1H/2026 record date OSAH to focus primarily on the re-establishment of USDA conditional approval and commercialization of immunotherapy...
2026-01-14 7:00 AM EST
OS Therapies Enters into Warrant Inducement Agreements
New York, New York--(Newsfile Corp. - January 12, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in listeria-based cancer immunotherapies, today announced that it launched a warrant exercise inducement and exchange offer to nine accredited investors (the "Holders") that hold common stock purchase warrants issued in connection with the Company's p
2026-01-12 8:01 AM EST
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 Program Biomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026 UK and EU Marketing Authorisation...
2026-01-05 7:40 AM EST
OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documents FDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory...
2025-12-15 6:00 AM EST
OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the 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. - December 9, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it held a successful pre-Marketing Authorisation Application (MAA) with the Unite
2025-12-09 7:40 AM EST
OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility
New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced the United States Food & Drug Administration (FDA) granted the Company waiver of the application fee for BLA 125867 for OST-HER2. Additionally, the European Medicines Agency (EMA) Co
2025-12-05 8:01 AM EST
OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health Organization
New York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene lisbac' for the non-proprietary name for the Company's HER2 targeted Listeria monocytogenes-based cancer immunotherapy product candidate OST-HER2. OST-HER2 is...
2025-11-25 9:21 AM EST
OS Therapies to Spinoff OS Animal Health into Standalone Public Company
Successful preliminary discussion with NYSE representatives and potential investors OS Therapies shareholders to receive direct equity participation in new listing 'Shelter Me: Cancer Pioneers' film featuring canine and human patients treated with OST-HER2 receives Anthem Award in the 'Documentary or Film under Awareness Categories, Health' category Company congratulates Disney (NYSE: DIS) for winning the 2025 Daytime Emmy 'Outstanding Daytime Special' category and Netflix (NYSE: NFLX) for...
2025-11-20 7:40 AM EST
OS Therapies Reports Third Quarter 2025 Financial Results and Provides Business Update
Type C Meeting with US FDA set for December 11, 2025 to address key items following August 27, 2025 End of Phase 2 Meeting regarding Phase 2b clinical trial of OST-HER2: prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma US Biologics Licensing Application (BLA) and UK MHRA Marketing Authorization Application filings for OST-HER2 expected in January 2025 leveraging Project Orbis UK MHRA pre-Marketing Authorization Application (MAA) meeting scheduled for December...
2025-11-17 6:00 AM EST
OS Therapies Announces Overall and Event Free Survival Key Subgroup Data for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - October 22, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced additional overall and event free survival data generated from the Company's 41-patient Phase 2b clinical trial of its off-the-shelf immunotherapeutic candidate OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma (the "Phase 2b...
2025-10-22 9:15 AM EDT