OS Therapies News Releases

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

Wed, 08 Jul 2026 09:00:00 -0400

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)...

OS Therapies Third Quarter 2026 Corporate Outlook

Mon, 06 Jul 2026 09:00:00 -0400

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...

OS Therapies Appoints Dr. Craig Eagle to Board of Directors

Thu, 02 Jul 2026 07:30:00 -0400

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 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. The Company also thanks Karim...

OS Therapies Provides U.S. Regulatory Update

Tue, 30 Jun 2026 07:40:00 -0400

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...

OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma

Fri, 26 Jun 2026 07:40:00 -0400

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...

OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma

Mon, 08 Jun 2026 06:00:00 -0400

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...

OS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma

Tue, 02 Jun 2026 06:00:00 -0400

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...

OS Therapies Announces the Publication of Four Articles on OST-HER2 and Osteosarcoma in Drug Discovery World

Fri, 29 May 2026 07:20:00 -0400

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 American: OSTX) ("OS Therapies" or "the Company"), the world leader...

OS Therapies to Attend Upcoming Medical, Financial and Industry Conferences

Tue, 26 May 2026 07:40:00 -0400

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 American: 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...

OS Therapies Reports First Quarter 2026 Financials and Provides Business Update

Mon, 18 May 2026 06:30:00 -0400

$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...