OS Therapies News Releases

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

Thu, 17 Sep 2026 06:00:00 -0400

FDA aligns with MHRA and EMA on adaptive design for Phase 3 trialAfter successful Scientific Advice Meeting, OS Therapies accepts MHRA request to become the Company's sponsor into Project Orbis to harmonize regulatory review with FDA and EMACBER recently re-opened Project Orbis to foreign-sponsored U.S. companies onlyNew 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...

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

Tue, 15 Sep 2026 07:46:00 -0400

Overall Survival (OS) historical-control data gains HMRA and EMA support for pending CMAA submissionsFull alignment achieved on confirmatory Phase 3 trial designComplete CMAA submission expected in coming weeksNew 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...

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

Tue, 08 Sep 2026 06:00:00 -0400

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 2026Company receives $3.15 million in VAT refunds into OS Therapies UK, Ltd. subsidiary, with an additional $7.2 million in refundable VAT and R&D Tax Credits pendingNew York, New York and Rockville,...

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

Wed, 02 Sep 2026 07:20:00 -0400

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 2026RMAT and Rolling Review decisions expected to follow U.S. FDA meetingFinal 3-year overall survival data,...

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

Mon, 17 Aug 2026 07:40:00 -0400

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...

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

Thu, 13 Aug 2026 08:45:00 -0400

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...

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...