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
OS Therapies Granted Final Type C Meeting by U.S. FDA and pre-MAA Meeting by U.K. MHRA for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - October 17, 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 that the United States Food & Drug Administration ("FDA") has granted a second Type C Meeting, following its successful End of Phase 2 Meeting. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints to suppor
2025-10-17 9:15 AM EDT
OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - October 10, 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 statistically significant positive final 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the "Full
2025-10-10 6:00 AM EDT
OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur Meeting
New York, New York--(Newsfile Corp. - October 9, 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 a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB). During the
2025-10-09 7:40 AM EDT
OS Therapies to Participate in Fall 2025 Conferences and Events
New York, New York--(Newsfile Corp. - October 7, 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 its participation in upcoming October 2025 conferences and events. Cell and Gene Meeting on the Mesa What: Partnering and one-on-one meeti
2025-10-07 11:50 AM EDT
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update
Company updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRA In principle, UK MHRA accepts use of historical control arm to support conditional MAA UK MHRA conditional MAA and US FDA Biologics Licensing Application (BLA) submissions expected to be completed within 30 days of each other, between December 2025 and January 2026...
2025-09-30 7:40 AM EDT
OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDT
New York, New York--(Newsfile Corp. - September 19, 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 that it has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeutics" Spotlight Panel at BioFuture 2025 taking place at Cure in New York City on October 13, 2025 at 11:00am EDT. A virtual partnering...
2025-09-19 7:40 AM EDT
OS Therapies Announces Last Patient Enrolled in OST-504 (previously ADXS-504) Phase 1b Prostate Cancer Clinical Trial Completes Last Visit
New York, New York--(Newsfile Corp. - September 12, 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 that the last patient enrolled in its OST-504 (previously ADXS-504) Phase 1b clinical trial in subjects with
2025-09-12 7:40 AM EDT
OS Therapies to Participate in Upcoming Investor Conferences in September 2025
New York, New York--(Newsfile Corp. - September 3, 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 that it will participate in the upcoming investor conferences: Cantor Global Healthcare Conference 2025 being held September 3-5, 2025 in New York City. Management will be available for meetings with institutional investors and brokers H.C. Wainwright 27th...
2025-09-03 7:40 AM EDT
OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 Meeting
New York, New York--(Newsfile Corp. - September 2, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today provided stakeholders with a detailed update regarding the Company's OST-HER2 recurrent, fully resected, pulmonary metastatic osteosarcoma program (the "Metastatic Osteosarcoma Program") following a highly productive End of Phase 2 Meeting with the US Food & Drug...
2025-09-02 7:40 AM EDT
OS Therapies Completes Exercise Inducement and Exchange Offer for All Remaining Outstanding Warrants Issued in Connection with December 2024 Financing
New York, New York--(Newsfile Corp. - September 2, 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 that it has completed a warrant inducement and exchange offer with the holders of all remaining outstanding warrants with an exercise price $1.1
2025-09-02 6:00 AM EDT
OS Therapies to Provide OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma FDA End of Phase 2 Meeting Update on Tuesday, September 2, 2025
New York, New York--(Newsfile Corp. - August 27, 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 that it will provide stakeholders with a detailed update regarding the Company’s highly constructive August 27, 2025 End of Phase 2 Meeting with the US Food & Drug Administration ("FDA") discussing the regulatory path forward towards approval for OST-HER2 in...
2025-08-27 4:01 PM EDT
OS Therapies Terminates Equity Line of Credit
New York, New York--(Newsfile Corp. - August 25, 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 that it terminated its Equity Purchase Agreement (the "ELOC") with Square Gate Capital Master Fund, LLC — Series 3, effective August 26, 2025. "The recent success of our warrant exercise inducement and exchange offering provided the Company with $4.2 million...
2025-08-25 9:51 PM EDT