OSTX

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

ASCO 2026: 2.5-Year Overall Survival DataJefferies Healthcare Conference: Partnering & Investor meetingsBIO International Convention: Panel ParticipationMIB Agents Factor Osteosarcoma Conference: Data PresentationNew York, New York and Rockville, Maryland--(Newsfile Corp. - May 26, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will attend upcoming medical, financial and scientific conferences:American Society of Clinical Oncologists 2026Where: Chicago, ILWhen: May 29, 2026 to June 2, 2026What: 2.5-year overall survival data announcementJefferies Global Healthcare Conference 2

$5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027$4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing Authorisations (CMAs) for OST-HER2 in prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma ("Metastatic Osteosarcoma")2.5-year overall survival data expected to be re

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

5/A - OS Therapies Inc (0001795091) (Issuer)

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

New York, New York and Rockville, Maryland--(Newsfile Corp. - May 15, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will announce first quarter 2026 financials and provide a business update on the morning of Monday May 18, 2026. About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. The Company is the world leader in listeria-based cancer immunotherapies. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimula

Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval ProgramCommercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussionsNew York, New York and Rockville, Maryland--(Newsfile Corp. - May 14, 2026) - OS Therapies, Inc. (NY

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

Conference call scheduled for Thursday, April 30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes validating the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic.EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical efficacy endpoint for Conditional Marketing Authorizations (CMAs), with alignment also achieved on confirmatory Phase 3 initiation, initially only in Australia, planned for Q3 2026 to meet regulatory requirement to support early a

Regulatory feedback recent from April 2026 EU EMA and Australian TGA meetingsRemaining Q2-2026 regulatory meetings include two U.S. FDA meetings and one UK MHRA meeting, in addition to follow-up meetings with EU EMA and Australian TGANew York, New York--(Newsfile Corp. - April 27, 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 will be hosting a conference call on Thursday April 30, 2026 at 8:30am ET to review the data that supported the recent Patent Cooperation Treaty (PCT) international application for a OST-HER2 pharmacodynamic biomarker1 (the "OST-HER2

New patent application covers treatment-emergent immune signature related to 'turning cold tumors hot' and the activation of targeted cytotoxic cellular immune responses Company to host conference call later in April 2026 to review new biomarker signatureBiomarker signature meets pharmacodynamic/response criteria established by FDA's Biomarkers, EndpointS and other Tools (BEST) program for use as a surrogate clinical endpoint of 1-year event free survival and 2-year overall survival in OST-HER2's Phase 2b trial in the prevention of delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma to support a BLA submission under FDA's Accelerated Approval ProgramNew York, New York--(New

Co-founder of more than 40 biotechnology companies, including 16 IPOs and 19 successful acquisitions Scientific and medical titan focused on driving innovation for human healthWill assist with listeria oncology pipeline prioritization, combinations with other oncology-focused biotechnologies and tADC candidate selection for further developmentNew York, New York--(Newsfile Corp. - April 13, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced today that Dr. Robert "Bob" S. Langer, co-founder of Moderna, was appointed to the Company's strategic advisory board. Dr. Langer will assist managemen

Senior leadership roles at Guardant Health, Genentech and PfizerRegulatory, clinical and commercial expertise in therapeutics and biomarkersWill assist with osteosarcoma regulatory advice and oncology pipeline prioritizationNew York, New York--(Newsfile Corp. - April 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 Craig Eagle, MD, was appointed to the Company's newly-formed strategic advisory board. The Company's strategic advisory board is being formed to assist the Company in fine-tuning its osteosarcoma regulatory execution plan and to help develop a detailed pipeline