OSTX

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 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 (CPRD) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). This comes after OS Therapies was accepted into the US Food and Drug Administration’s (FDA) Project Orbis, where 29 MHRA-led oncolo

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: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 alignment on the commercial development pathway for OST-HER2 in the treatment of canine osteosarcoma. USDA provided guidance related to the OSAH's upcoming conditional licensure request in the areas of clinical e

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 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:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced statistically significant final 3-year overall survival benefit for OST-HER2-

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8-K - OS Therapies Inc (0001795091) (Filer)

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: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 Financial Officer (CFO).Mr. Clem now leads the Company's U.S., U.K., and European commercialization strategy and launch planning for Herlystic™ (OST-HER2; daznelimgene lisbac), the Company's investigational imm

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 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 previously approved WHO. With both the branded proprietary name and the nonproprietary name now approved by WHO, the Company is positioned to initiate regulatory submissions seeking early market access for OST-HER2 wor

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, coupled with granting the Company access to U.K. national patient registry, the UK Clinical Practice Research Datalink (CPRD) to strengthen comparator data while Phase 3 is ongoing to further improve int

S-8 - OS Therapies Inc (0001795091) (Filer)

FDA aligns with MHRA and EMA on adaptive design for Phase 3 trialAfter successful Scientific Advice Meeting, Company accepts MHRA request to become he 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:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has achieved incremental alignment with the U.S. Food & Drug Administration (FDA) in the Company's pursuit of a Biologics License Applicatio

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: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 the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on its pending Conditional Marketing Authorisation Application (CMAA). MHRA agreed that the use of comparable historical control data – derived

8-K - OS Therapies Inc (0001795091) (Filer)

424B7 - OS Therapies Inc (0001795091) (Filer)

8-K - OS Therapies Inc (0001795091) (Filer)

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, Maryland--(Newsfile Corp. - September 8, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced a statistica

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, U.S. FDA Pre-BLA Meeting, BLA submission, MHRA CMAA submission, and EMA CMAA submission expected in Q4 2026Confirmatory Phase 3 Clinical Trial Application to follow MHRA meeting for Q4 2026 trial commenc

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8-K - OS Therapies Inc (0001795091) (Filer)

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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 MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteriaFinal 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submissio

10-Q - OS Therapies Inc (0001795091) (Filer)

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 Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has gr

8-K - OS Therapies Inc (0001795091) (Filer)

8-K - OS Therapies Inc (0001795091) (Filer)