Leading Clinical Stage Oncology Company Now Able to Complete CMMA Submission to U.K's MHRA for Early Commercial Access and Trial AuthorisationGrasonville, Maryland--(Newsfile Corp. - November 5, 2026) - OS
Proceeds from the initial closing, together with accrued refundable U.K. R&D tax credits, expected to provide operating runway through major upcoming milestonesCompany expects to complete early market access
NEW YORK, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Rubenstein Public Relations (RPR), a leading full-service communications firm, announces it has been named the Agency of Record for OS Therapies, Inc. (NYSE:OSTX), the
Received notice for upcoming USDA meetingCompany is reviewing strategic alternatives to monetize OS Animal Health ("OSAH")Grasonville, Maryland--(Newsfile Corp. - October 7, 2026) - OS Therapies, Inc.
Leading Clinical Stage Oncology Company Releases Significant Findings from OST-HER2-Treated Patients72.7 percent three-year overall survival vs. 45.8 percent comparable combined historical control (p = 0.0006)Company
Experienced biotech leaders to focus on preparations for U.S., U.K., and European commercial launch of the Company's lead product candidate Herlystic™(OST-HER2; daznelimgene lisbac)Grasonville, Maryland--(Newsfile
New York, New York and Rockville, Maryland--(Newsfile Corp. - September 24, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based
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
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
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,
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
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
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
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
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.
