OS Therapies Announces Shelving of U.S. FDA Commissioner's National Priority Voucher Has No Impact on the Company
Grasonville, Maryland--(Newsfile Corp. - November 13, 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 the FDA's shelving of the Commissioner's National Priority Voucher ("CNPV") has no impact on the Company's rare pediatric disease PRV prospects. The shelving does not affect
2026-11-13 8:30 AM EST
OS Therapies Initiates U.K. MHRA Conditional Marketing Authorisation Application for Herlystic (OST-HER2) in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma
Grasonville, Maryland--(Newsfile Corp. - November 10, 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 has initiated a Conditional Marketing Authorisation Application (CMAA) process with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for Herlystic™ (OST-HER2) in the prevention or delay of recurrence in fully resected, pulmonary metastatic...
2026-11-10 8:15 AM EST
OS Therapies Completes Requalification of Phase 2b Herlystic (OST-HER2) Drug Substance for Confirmatory Phase 3 Trial
Grasonville, Maryland--(Newsfile Corp. - November 5, 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 has completed the requalification of drug substance used in its Phase 2b trial of OST-HER2 (Herlystic™) in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma. The requalification is key as the Company is now able to commence the...
2026-11-05 8:00 AM EST
OS Therapies Announces Initial Closing of Warrant Exercise Inducement and Exchange Offer for Initial Gross Proceeds of Approximately $7.2 Million
Grasonville, Maryland--(Newsfile Corp. - October 19, 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 initial closing of a warrant exercise inducement and exchange offer that was made to nine accredited investors (the "
2026-10-19 8:30 AM EDT
OS Animal Health Receives USDA Feedback on Regulatory Pathway for OST-HER2 in Canine Osteosarcoma
Grasonville, Maryland--(Newsfile Corp. - October 7, 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 wholly-owned animal health subsidiary, OSAH received feedback from the U.S. Department of Agriculture (USDA) related to its submission to gain alignment on the commercial development pathway for OST-HER2 in the treatment of canine osteosarcoma. USDA provided...
2026-10-07 8:30 AM EDT
OS Therapies Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma Trial
Grasonville, Maryland--(Newsfile Corp. - October 6, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced statistically significant final 3-year overall survival benefit for OST-HER2-treated p
2026-10-06 8:30 AM EDT
OS Therapies Appoints Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer
Grasonville, Maryland--(Newsfile Corp. - October 1, 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 appointment of Kerry Clem as Chief Commercial Officer (CCO) and Frank Knuettel II as Chief Financial Officer (CFO). Mr. Clem now leads the Company's U.S., U.K., and European commercialization strategy and launch planning for Herlystic™ (OST-HER2; dazn
2026-10-01 8:30 AM EDT
OS Therapies Announces Brand Name 'Herlystic' Approved by World Health Organization for OST-HER2 (daznelimgene lisbac)
New York and Rockville, Maryland--(Newsfile Corp. - September 24, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announce that the World Health Organization has approved the proprietary name 'Herlystic'™ was approved by the World Health Organization (WHO) as the brand name for OST-HER2. The nonproprietary name daznelimgene lisbac for the ingredients in OST-HER2 was previously...
2026-09-24 8:22 AM EDT
OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis
Recent U.K. MHRA Scientific Advice Meeting (SAM) that resulted in full alignment to initiate confirmatory Phase 3 trial in U.K. with existing Phase 2 drug product paved the way Conditional Marketing Authorisation Application (CMAA) submission in the coming weeks and Phase 3 trial initiation in mid Q4/'26 following Phase 2b drug product requalification MHRA's SAM participants' recommendation to Project Orbis U.K. leadership to take the global regulatory leadership mantle with U.S. FDA and EMA,...
2026-09-21 6:30 AM EDT
OS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2 Metastatic Osteosarcoma Program
New York and Rockville, Maryland--(Newsfile Corp. - September 17, 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 has achieved incremental alignment with the U.S. Food & Drug Administration (FDA) in the Company's pursuit of a Biologics L
2026-09-17 6:00 AM EDT
OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing
New York and Rockville, Maryland--(Newsfile Corp. - September 15, 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 has achieved full alignment with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on its pending Conditional Marketing Authorisation Application (CMAA). MHRA agreed that the use of comparable historical control
2026-09-15 7:46 AM EDT
OS Therapies Achieves Statistically Significant Benefit for OST-HER2-Treated Patients in Interim 3-Year Overall Survival Analysis of Phase 2b Pulmonary Metastatic Osteosarcoma Trial
New York and Rockville, Maryland--(Newsfile Corp. - September 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
2026-09-08 6:00 AM EDT
OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance
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...
2026-09-02 7:20 AM EDT
OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates
Up to $10 million debt financing supported by U.K. subsidiary VAT refunds and reimbursable R&D tax credits, including $5 million funded at the August 10, 2026 first closing FDA Type C Statistical Methods Meeting mid-September 2026 meeting to review 2.5-year Overall Survival data and confirmatory Phase 3 trial design to gain alignment on statistical analysis plan for BLA submission under the Accelerated Approval Program Interim 3-year Overall Survival data expected in early September 2026...
2026-08-17 7:40 AM EDT
OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma
New York and Rockville, Maryland--(Newsfile Corp. - August 13, 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 the U.S. F
2026-08-13 8:45 AM EDT
OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program
New York and Rockville, Maryland--(Newsfile Corp. - July 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 it has accepted a new Meeting Request from the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) to review the Company's pharmacodynamic response biomarker data (the "OST-HER2 Biomarker Data") – patent pending. CDER's...
2026-07-08 9:00 AM EDT
OS Therapies Third Quarter 2026 Corporate Outlook
New York and Rockville, Maryland--(Newsfile Corp. - July 6, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today provides a third quarter 2026 corporate outlook. The outlook focuses on upcoming clinical and regulatory milestones for the Company's lead program OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic...
2026-07-06 9:00 AM EDT
OS Therapies Appoints Dr. Craig Eagle to Board of Directors
New York and Rockville, Maryland--(Newsfile Corp. - July 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 it has appointed Dr. Craig Eagle to the Company's Board of Directors. Dr. Eagle currently serves as the Company's Chief Medical Advisor. The Company also thanks Karim Galzahr for his service to the Board of Directors and will continue as a member of the...
2026-07-02 7:30 AM EDT
OS Therapies Provides U.S. Regulatory Update
New York and Rockville, Maryland--(Newsfile Corp. - June 30, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in
2026-06-30 7:40 AM EDT
OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma
Rockville, Maryland--(Newsfile Corp. - June 26, 2026) - OS Animal Health, Inc. ("OS Animal Health" or "the Company")
2026-06-26 7:40 AM EDT