OS Therapies Inc

OSTX

Market cap $53.5M

FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussions OS Therapies on track to complete clinical data submission by the end of Q1 2026 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, fully resected, pulmonary metastatic osteosarcoma. FDA elevated OS Therapies' Type D Biomarker Meeting to a Type B pre-BLA Meeting, expected to occur shortly after the Company completes submission of its clinical data package to the agency, targeted for the end of the first quarter of 2026.

OS Therapies on Tuesday said it expects to complete conditional Marketing Authorization Application (MAA) submissions to both the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) by the end of the first quarter of 2026.

Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomes U.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial design Ayala Pharmaceuticals announces dissolution following liquidation of assets 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 osteosarcoma (the "Human Metastatic Osteosarcoma Program"). Following the submission of the Non-Clinical and Chemistry, Manufacturing & Controls (CMC) modules of its Biologics License Application (BLA) to U.S. Food & Drug Administration (FDA) at the end of January 2026, the Company anticipates releasing additional biomarker data from its Human Metastatic Osteosarcoma Program in the first quarter of 2026.

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.

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) designation requests update submitted to FDA with recent biomarker data Company remains on track to be eligible to receive Priority Review Voucher under Rare Pediatric Disease Designation (RPDD) with approval anticipated by September 30, 2026 New York, New York--(Newsfile Corp. - February 2, 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 formally initiated a Biologics License Application (BLA) submission to the U.S. Food & Drug Administration (FDA) for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma ("Human Metastatic Osteosarcoma"). The Company has submitted the Non-Clinical and the Chemistry, Manufacturing, and Controls (CMC) modules of the BLA to FDA, along with a request for Rolling Review.

OS Therapies Incorporated (NYSE: OSTX) shares are down on Thursday following the announcement of positive biomarker data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, a type of bone cancer.

Activation of immune blood biomarkers from interferon gamma pathway distinguished long term survivors (>=2 years) from short-term survivors (=2 years) from short-term survivors (

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 OST-HER2 for canine osteosarcoma and other HER2 positive cancers in animals OST-HER2 featured in 2025 2x Emmy-nominated and Anthem Award-winning documentary 'Shelter Me: Cancer Pioneers' streaming on PBS OSTX reiterates release date of January 15, 2026 for biomarker data from Phase 2b OST-HER2 trial in human pulmonary metastatic osteosarcoma that will be used to support upcoming Biologics License Application submission with US FDA New York, New York--(Newsfile Corp. - January 14, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that its wholly-owned subsidiary OS Animal Health Corp (OSAH) has filed a Form S-1 with the Securities Exchange Commission (SEC) in preparation for an Initial Public Offering (IPO). OSAH intends to list on either the NYSE American or Nasdaq Capital Markets national stock exchange in the first half of 2026 (1H/2026).

$7.53M gross proceeds raised from pre-existing investors, providing capital runway into 2027 All nine investors that were offered agreed to participate Net proceeds to fund OST-HER2 regulatory approval submissions, commercial preparation activities and preparations for OS Animal Health proposed spinoff transaction 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 previous third quarter 2025 warrant exercise inducement and exchange offers (the "Existing Warrants"). All nine Holders offered have entered into inducement offer letter agreements with the Company to exercise or pre-fund for cash all of their Existing Warrants, providing a total of $7.53 million in gross proceeds to the Company.

NEW YORK, Jan. 5, 2026 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating OS Therapies Incorporated (NYSE American: OSTX) on behalf of the company's shareholders. The investigation seeks to determine whether OS Therapies's directors breached their fiduciary duties in connection with recent corporate actions.