OS Therapies Incorporated

Leading Clinical Stage Oncology Company Now Able to Complete CMMA Submission to U.K's MHRA for Early Commercial Access and Trial Authorisation Grasonville, Maryland--(Newsfile Corp. - November 5, 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 completed the requalification of drug substance used in its Phase 2b trial of OST-HER2 (Herlystic™) in the prevention o…

Proceeds from the initial closing, together with accrued refundable U.K. R&D tax credits, expected to provide operating runway through major upcoming milestones Company expects to complete early market access regulatory approval submissions for Herlystic™ ("OST-HER2" or "daznelimgene lisbac") in the U.S., U.K., Europe and Australia in the fourth quarter of 2026 Grasonville, Maryland--(Newsfile Corp. - October 19, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), …

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 American: OSTX), the world leader in gene-edited, Listeria-based cancer immunotherapies. Recently, OS Therapies announced that it has reached a critical point in achieving entry into the global market with access into the U.K national patient registry and UK Clinical Practice Research Datalink (C…

Received notice for upcoming USDA meeting Company is reviewing strategic alternatives to monetize OS Animal Health ("OSAH") Grasonville, Maryland--(Newsfile Corp. - October 7, 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 its wholly-owned animal health subsidiary, OSAH received feedback from the U.S. Department of Agriculture (USDA) related to its submission to gain …

OS Therapies Inc. (NYSE:OSTX) announced a statistically significant three-year overall survival benefit for patients treated with OST-HER2 in its Phase 2b trial.

Leading Clinical Stage Oncology Company Releases Significant Findings from OST-HER2-Treated Patients 72.7 percent three-year overall survival vs. 45.8 percent comparable combined historical control (p = 0.0006) Company preparing to complete submissions for early market access in the U.S., U.K., Europe and Australia WHO recently accepted the proprietary brand name Herlystic™ for OST-HER2 (daznelimgene lisbac).

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 Corp. - October 1, 2026) - OS Therapies, Inc . (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced the appointment of Kerry Clem as Chief Commercial Officer (CCO) and Frank Knuettel II as Chie…

New York, New York and Rockville, Maryland--(Newsfile Corp. - September 24, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announce that the World Health Organization has approved the proprietary name 'Herlystic' was approved by the World Health Organization (WHO) as the brand name for OST-HER2. The nonproprietary name daznelimgene lisbac for the ingredients in OST-HER2 was previous…

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 Application (CMAA) submission in the coming weeks and Phase 3 trial initiation in mid Q4/'26 following Phase 2b drug product requalification MHRA's SAM participants' recommendation to Project Orbis U.K. leadership to take the global regulatory leadership mantle with U.S. FDA and EMA, co…

FDA aligns with MHRA and EMA on adaptive design for Phase 3 trial After successful Scientific Advice Meeting, Company accepts MHRA request to become he Company's' sponsor into Project Orbis to harmonize regulatory review with FDA and EMA CBER recently re-opened Project Orbis to foreign-sponsored U.S. companies only New 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 gen…

Overall Survival (OS) historical-control data gains HMRA and EMA support for pending CMAA submissions Full alignment achieved on confirmatory Phase 3 trial design Complete CMAA submission expected in coming weeks New 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 wit…

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 2026 Company receives $3.15 million in VAT refunds into OS Therapies UK, Ltd.

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

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 closing FDA 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 Program Interim 3-year Overall Survival data expected in early September 2026 ahead o…

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