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OSTX

OS Therapies Inc

OSTX

Market cap $82.8M

1.77 USD

+0.03

1.72%

At close Updated Sep 22, 4:00 PM EDT

Pre-market

After hours

1.79

+0.02

1.13%

1 day

1.72%

5 days

-1.12%

1 month

14.19%

3 months

-2.75%

6 months

16.45%

Year to date

32.09%

1 year

-19.91%

5 years

-29.48%

10 years

-29.48%

About: OS Therapies Inc is a clinical stage biopharmaceutical company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. The company's mission is to address the need for new treatments in cancers of the bone in children and young adults. The company has pipeline of product candidates targeting multiple indications for solid cancers including two drug technologies: (i) OST-HER2, an off-the-shelf immunotherapy, which is a type of cancer treatment that helps the immune system fight cancer and OST-tADC which is a tunable drug conjugate (tADC) platform currently in preclinical development. Each tADC contains four main components: ligand, payload cassette adaptor, linker and payload.

Employees: 5

Healthcare Drug Manufacturers - General

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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, coupled with granting the Company access to U.K. national patient registry, the UK Clinical Practice Research Datalink (CPRD) to strengthen comparator data while Phase 3 is ongoing to further improve interpretability of data during early market access phase Since 2021, 29 MHRA-led products have been approved by U.S. FDA via Project Orbis Company continues to engage with U.S. FDA on the non-Orbis Accelerated Approval route after successful Type C Statistical Methods Meeting that resulted in alignment on amended Phase 3 study design as buildout of OST-400 natural history database expands to include U.K. national patient registry data and Company awaits FDA decisions on RMAT, Rolling Review and CNPV ahead of the pending Q4/'26 completion of its ongoing BLA filing initiated in Q1/'26 BLAs granted via Project Orbis are eligible to receive Priority Review Vouchers (PRVs) and may also be granted via the Accelerated Approval Program Patient previously reported as lost to follow-up confirmed to be alive New York, New York and Rockville, Maryland--(Newsfile Corp. - September 21, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today provided an update on global early market access regulatory coordination efforts being led by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) following the Company's acceptance of MHRA's request to become the lead regulatory agency to drive early market access for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program") under Project Orbis. Project Orbis is the U.S. Food & Drug Administration (FDA) Oncology Center of Excellence (OCE) initiative started in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.

OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis

OS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2 Metastatic Osteosarcoma Program

FDA aligns with MHRA and EMA on adaptive design for Phase 3 trial After successful Scientific Advice Meeting, Company accepts MHRA request to become he Company's' sponsor into Project Orbis to harmonize regulatory review with FDA and EMA CBER recently re-opened Project Orbis to foreign-sponsored U.S. companies only New York, 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 License Application (BLA) for OST-HER2 in the prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program"). The Company aligned with the FDA on the use of the proposed adaptive design agreed upon with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) for the pending Phase 3 clinical trial that is expected to commence in the fourth quarter of 2026.

OS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2 Metastatic Osteosarcoma Program

OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing

Overall Survival (OS) historical-control data gains HMRA and EMA support for pending CMAA submissions Full alignment achieved on confirmatory Phase 3 trial design Complete CMAA submission expected in coming weeks New York, 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 data – derived from a systematic evaluation of all suitable available peer-reviewed literature by independent biostatistics advisors presented in its most recent Scientific Advice Meeting (SAM) - was appropriate in the orphan indication Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma.

OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing

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

71.2% 3-year overall survival for OST-HER2-treated patients vs. 45.8% comparable combined historical control (p = 0.002) The two remaining patients who have not yet reached the 3-year timepoint from enrollment have trial monitoring visits scheduled for September 2026 and early October 2026 Company receives $3.15 million in VAT refunds into OS Therapies UK, Ltd.

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

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 data, U.S. FDA Pre-BLA Meeting, BLA submission, MHRA CMAA submission, and EMA CMAA submission expected in Q4 2026 Confirmatory Phase 3 Clinical Trial Application to follow MHRA meeting for Q4 2026 trial commencement OS Animal Health to attend Moody Capital Disruptive Growth & Life Sciences Conference New York and Rockville, Maryland--(Newsfile Corp. - September 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 its management team, its business development advisors and the management team of its wholly-owned subsidiary OS Animal Health will participate in upcoming conferences, and provided a program update for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program"): Jefferies Global Healthcare Conference: London - November 16-19, 2026 H.C.

OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance

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 ahead of MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteria Final 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submission ahead of Type B Pre-BLA Meeting previously granted in Q2/26 U.K. waives Pediatric Investigation Plan (PIP) requirement New York and Rockville, Maryland--(Newsfile Corp. - August 17, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today reported financial results for the second fiscal quarter ended June 30, 2026, and provided business and regulatory updates. The Company is seeking to obtain a Biologics License Application (BLA) under the Accelerated Approval Program of the U.S. Food & Drug Administration (FDA), and equivalent Conditional Marketing Accelerated Authorisations (CMAAs) from the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA), for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").

OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates

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

Meeting to occur in mid-September 2026 Interim 3-year Overall Survival data expected early September, 2026 Decisions on appropriate comparator arm to interpret OST-HER2 clinical efficacy, RMAT designation and Rolling Review expected following this meeting Sustained overall survival benefit observed between 2-year and 2.5-year timepoints U.K. MHRA Statistical Methods Scientific Advice Meeting granted in parallel New York, 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. Food and Drug Administration (FDA) has granted the Company's requested Type C Statistical Methods meeting to review the 2.5 year overall survival data from the Phase 2b trial of OST-HER2 in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Trial"). The Company expects the FDA Type C Statistical Methods Meeting to occur in mid-September 2026 with members from division within the Center for Biologics Evaluation and Research (CBER), in parallel with the pending Biomarker Data Review Meeting being scheduled with members of the Center for Drug Evaluation and Research's (CDER) Biomarker Qualification Program (BQP).

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

OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program

CDER meeting expected to take place in the summer of 2026 in parallel with CBER's Type B Statistical Methods Meeting New York, 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 Biomarkers, EndpointS, and other Tools (BEST) resources is part of its Biomarker Qualification Program (BQP).

OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program

OS Therapies Third Quarter 2026 Corporate Outlook

Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access New York, 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 Osteosarcoma Program"), advancements with the Company's animal health-focused subsidiary OS Animal Health, Inc. (OSAH) and the Company's financial position as key regulatory and corporate milestones come into focus.

OS Therapies Third Quarter 2026 Corporate Outlook

OS Therapies Appoints Dr. Craig Eagle to Board of Directors

Company secures $10 million line of credit supported by OS Therapies UK tax credits New York, 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.

OS Therapies Appoints Dr. Craig Eagle to Board of Directors

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