OS Therapies Inc

OSTX

市值 US$6178萬

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 (CPRD) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

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 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 efficacy, clinical safety, non-clinical and Chemistry, Manufacturing and Controls (CMC) as a prelude to commercialization.

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 Chief Financial Officer (CFO).

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 previously approved WHO.

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, 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 interpretability of data during early market access phase Since 2021, 29 MHRA-led products have been approved by U.S. FDA via Project Orbis Company continues to engage with U.S. FDA on the non-Orbis Accelerated Approval route after successful Type C Statistical Methods Meeting that resulted in alignment on amended Phase 3 study design as buildout of OST-400 natural history database expands to include U.K. national patient registry data and Company awaits FDA decisions on RMAT, Rolling Review and CNPV ahead of the pending Q4/'26 completion of its ongoing BLA filing initiated in Q1/'26 BLAs granted via Project Orbis are eligible to receive Priority Review Vouchers (PRVs) and may also be granted via the Accelerated Approval Program Patient previously reported as lost to follow-up confirmed to be alive New York, New York and Rockville, Maryland--(Newsfile Corp. - September 21, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today provided an update on global early market access regulatory coordination efforts being led by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) following the Company's acceptance of MHRA's request to become the lead regulatory agency to drive early market access for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program") under Project Orbis. Project Orbis is the U.S. Food & Drug Administration (FDA) Oncology Center of Excellence (OCE) initiative started in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.

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 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 Application (BLA) for OST-HER2 in the prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program"). The Company aligned with the FDA on the use of the proposed adaptive design agreed upon with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) for the pending Phase 3 clinical trial that is expected to commence in the fourth quarter of 2026.

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 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 from a systematic evaluation of all suitable available peer-reviewed literature by independent biostatistics advisors presented in its most recent Scientific Advice Meeting (SAM) - was appropriate in the orphan indication Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma.

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.