OS Therapies News Releases

OS Therapies Announces Initial Closing of Warrant Exercise Inducement and Exchange Offer for Initial Gross Proceeds of Approximately $7.2 Million

Mon, 19 Oct 2026 08:30:00 -0400

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 regulatory approval submissions for Herlystic™ ("OST-HER2" or "daznelimgene lisbac") in the U.S., U.K., Europe and Australia in the fourth quarter of 2026Grasonville, Maryland--(Newsfile Corp. - October 19, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"),...

OS Animal Health Receives USDA Feedback on Regulatory Pathway for OST-HER2 in Canine Osteosarcoma

Wed, 07 Oct 2026 08:30:00 -0400

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. (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 Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma Trial

Tue, 06 Oct 2026 08:30:00 -0400

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 AustraliaWHO recently accepted the proprietary brand name Herlystic™ for OST-HER2 (daznelimgene lisbac).Grasonville, Maryland--(Newsfile Corp. - October 6, 2026) - OS Therapies, Inc. (NYSE...

OS Therapies Appoints Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer

Thu, 01 Oct 2026 08:30:00 -0400

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 Chief...

OS Therapies Announces Brand Name 'Herlystic' Approved by World Health Organization for OST-HER2 (daznelimgene lisbac)

Thu, 24 Sep 2026 08:22:00 -0400

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...

OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis

Mon, 21 Sep 2026 06:30:00 -0400

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 requalificationMHRA's SAM participants' recommendation to Project Orbis U.K. leadership to take the global regulatory leadership mantle with U.S. FDA and EMA,...

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,...