OSTX

D - OS Therapies Inc (0001795091) (Filer)

8-K - OS Therapies Inc (0001795091) (Filer)

424B5 - OS Therapies Inc (0001795091) (Filer)

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 closingFDA 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 ProgramInterim 3-year Overall Survival data expected in early September 2026 ahead of MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteriaFinal 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submissio

10-Q - OS Therapies Inc (0001795091) (Filer)

Meeting to occur in mid-September 2026Interim 3-year Overall Survival data expected early September, 2026Decisions on appropriate comparator arm to interpret OST-HER2 clinical efficacy, RMAT designation and Rolling Review expected following this meetingSustained overall survival benefit observed between 2-year and 2.5-year timepointsU.K. MHRA Statistical Methods Scientific Advice Meeting granted in parallelNew York, New York and Rockville, Maryland--(Newsfile Corp. - August 13, 2026) - OS Therapies, Inc. (NYSE: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 gr

8-K - OS Therapies Inc (0001795091) (Filer)

8-K - OS Therapies Inc (0001795091) (Filer)

424B5 - OS Therapies Inc (0001795091) (Filer)

8-K - OS Therapies Inc (0001795091) (Filer)

DEFA14A - OS Therapies Inc (0001795091) (Filer)

DEF 14A - OS Therapies Inc (0001795091) (Filer)

3 - OS Therapies Inc (0001795091) (Issuer)

D - OS Therapies Inc (0001795091) (Filer)

Roth Capital initiated coverage of OS Therapies with a rating of Buy and set a new price target of $7.00

CDER meeting expected to take place in the summer of 2026 in parallel with CBER's Type B Statistical Methods MeetingNew York, New York and Rockville, Maryland--(Newsfile Corp. - July 8, 2026) - OS Therapies, Inc. (NYSE: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 Qualifica

8-K/A - OS Therapies Inc (0001795091) (Filer)

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 accessNew York, New York and Rockville, Maryland--(Newsfile Corp. - July 6, 2026) - OS Therapies, Inc. (NYSE: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 Osteos

8-K - OS Therapies Inc (0001795091) (Filer)

Company secures $10 million line of credit supported by OS Therapies UK tax creditsNew York, New York and Rockville, Maryland--(Newsfile Corp. - July 2, 2026) - OS Therapies, Inc. (NYSE: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. The Company also thanks Karim Galzahr for his service to the Board of Directors and will continue as a member of the Company's advisory board."Having enjoyed participating in recent U.S., European and U.K. regulatory meetings as we prepare for

Type B Meeting requested to follow up on September 2025 End of Phase 2 FDA Meeting guidance on statistical methods to be used for BLA SubmissionSeeking to align FDA with MHRA & EMA on 3-year overall survival as approval endpointBiomarker data submitted to FDA BEST program as surrogate clinical efficacy dataSynthetic historical control arm OST-400 recruitment potentially adds comparator for BLA submission under the Accelerated ApprovalReview of Rolling Review, RMAT & Breakthrough Therapy designation requests soughtNew York, New York and Rockville, Maryland--(Newsfile Corp. - June 30, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Lis

20% of OST-HER2 treated dogs survived 2-year vs. 1% in control group (p = 0.00995)Over 15,000 dogs per year diagnosed with osteosarcomaCompany expects to submit U.S. Department of Agriculture meeting request to gain alignment on regulatory path towards conditional approval in the third quarter of 2026OS Therapies reiterates plan to distribute OS Animal Health shares to shareholdersOS Animal Health plans crowdfunding to expand shareholder base to meet U.S. national exchange initial listing standards, with indications of interest now being receivedRockville, Maryland--(Newsfile Corp. - June 26, 2026) - OS Animal Health, Inc. ("OS Animal Health" or "the Company"), the wholly-owned animal health

Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and AustraliaPatent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpointTGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC)Market access process initiated with UK NICE and EU JCANew York, New York and Rockville, Maryland--(Newsfile Corp. - June 8, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based c

75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs. 60%, p = 0.034)Updated clinical efficacy data being added to regulatory dossiers as Company seeks early market authorizations in U.S., U.K., Europe and Australia in 2nd half of 2026EMA and Australia TGA (TGA) alignment achieved on early Q4-2026 3-year overall survival data, supported by biomarker data, as key approvable clinical efficacy endpointUpcoming U.S. FDA and U.K. MHRA meetings seek alignment with EMA and TGA on Phase 2b 3-year overall survival and biomarker data to support early market access Conf

The Company confirms that it will release 2.5 year overall survival data from Phase 2b clinical trial OST-HER2 in the prevention or delay of recurrence in fully-resected pulmonary metastatic osteosarcoma during the 2026 American Society of Clinical Oncologists (ASCO) Annual Meeting being held from May 28, 2026 to June 2, 2026.New York, New York and Rockville, Maryland--(Newsfile Corp. - May 29, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced the publication of four articles related to OST-HER2 and/or Osteosarcoma in Drug Discovery World.Looking back to see forward: The future of