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
OS Therapies Announces Positive Data for OST-HER2 in the Treatment of Unresected Osteosarcoma in Dogs Opening the Potential for Use as Front-Line Therapy in Humans
Yet to be published data from clinical study combining OST-HER2 with palliative radiation in dogs with unresected, primary osteosarcoma shows clinical and radiographic arrest of the primary tumor, delayed pulmonary metastases and prolonged overall survival of greater than 500 days in 5 out of 15 dogs. Data from new publication in the journal "Molecular Therapy" show OST-HER2 induces strong innate and cytotoxic immune responses beginning at the 1st dose of 3 dose regimen, that correlate with...
2025-04-10 7:40 AM EDT