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
OS Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update
U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT) FDA issues OST-HER2 BLA number in preparation for Accelerated Approval submission following End of Phase 2 Meeting FDA End of Phase 2 Meeting scheduled for August 27, 2025 to review Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcoma Statistically significant 12-month Event Free Survival and interim 2-year Overall Survival and strong...
2025-08-19 6:00 AM EDT
OS Therapies to Report Second Quarter 2025 Financial Results and Provide Business Update on Tuesday, August 19th, 2025
New York, New York--(Newsfile Corp. - August 14, 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 report second quarter 2025 financial results ended June 30, 2025 and provide a business update on the morning of Tuesday, August 19, 2025. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification,...
2025-08-14 5:44 PM EDT
OS Therapies Announces Statistically Significant Positive Interim 2-Year Overall Survival Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced...
2025-08-07 9:00 AM EDT
OS Therapies Receives Positive Feedback from UK MHRA Scientific Advice Meeting and Submits Innovative Licensing and Access Pathway (ILAP) Request for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - August 7, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it held a successful Scientific Advice Meeting with the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) in July and has submitted an invited Innovative Licensing and Access Pathway (ILAP) application to begin the regulatory...
2025-08-07 6:00 AM EDT
OS Therapies Closes $4.2 Million in Warrant Exercise Inducement and Exchange Offer
New York, New York--(Newsfile Corp. - July 14, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has closed its previously announced warrant exercise inducement and exchange offer. The Company raised a total of $4.2 million in gross p
2025-07-14 7:40 AM EDT
OS Therapies Provides Clinical & Global Regulatory Updates
New York, New York--(Newsfile Corp. - July 10, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a clinical and global regulatory update on its c
2025-07-10 7:40 AM EDT