Welcome to our dedicated page for OS THERAPIES INCORPORATED news (Ticker: OSTX), a resource for investors and traders seeking the latest updates and insights on OS THERAPIES INCORPORATED stock.
OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage oncology and biopharmaceutical company focused on osteosarcoma and other solid tumors. News about OS Therapies centers on its listeria-based cancer immunotherapy programs, regulatory interactions, capital markets activity, and the planned spin-off of its veterinary oncology subsidiary, OS Animal Health.
A major theme in OSTX news flow is the progress of OST-HER2 (daznelene lisbac), the company’s lead listeria-based immunotherapy targeting the HER2 protein. Press releases highlight positive Phase 2b data in recurrent, fully resected, pulmonary metastatic osteosarcoma, including statistically significant benefit in 12-month event free survival and reported 2-year overall survival outcomes. The company also reports immune biomarker analyses from its human metastatic osteosarcoma trial and related canine osteosarcoma studies, emphasizing the role of Comparative Oncology and interferon gamma pathway biomarkers as potential surrogate markers of clinical efficacy.
Investors following OSTX news will see regular updates on regulatory milestones, such as FDA Type C and other meetings, waiver of the BLA application fee for OST-HER2, EMA Union Marketing Authorisation eligibility, and preparations for Biologics License Application and Marketing Authorisation Application submissions in the United States, United Kingdom, and European Union. Company outlook releases describe anticipated timelines for regulatory submissions, potential conditional approvals, and planned interactions with FDA, MHRA, and EMA.
OS Therapies also issues news on capital raising and corporate transactions, including warrant exercise inducement agreements, gross proceeds from warrant exercises, and the intended use of proceeds to fund OST-HER2 regulatory and commercial preparation activities and the proposed OS Animal Health spin-off. Additional news items cover the veterinary oncology strategy for canine osteosarcoma, recognition of OST-HER2 in documentaries and awards, and the development of the company’s tunable ADC (tADC) platform.
For readers tracking OSTX, this news feed provides a consolidated view of clinical trial updates, biomarker findings, regulatory developments, financing events, and the evolution of both the human and animal health franchises. Regular visits can help investors and observers monitor how OS Therapies advances OST-HER2 and its broader oncology pipeline through key clinical and regulatory inflection points.
OS Therapies (NYSE: OSTX) reported third quarter 2025 results and a regulatory update ahead of planned filings. Key clinical data show 2-year overall survival 75% vs 40% (p < 0.0001) for OST-HER2 versus historical control, with selected subgroup results noted. The company scheduled a Type C FDA meeting on December 11, 2025 and a UK MHRA pre-MAA meeting on December 8, 2025 and expects to file the US BLA and UK MAA in January 2026. Financing actions included a $7.8M warrant exercise/inducement and replacement of an equity line with an ATM program; cash available was $1.9M at quarter end plus $1.5M received post-period.
OS Therapies (NYSE American: OSTX) announced subgroup overall survival (OS) and event-free survival (EFS) data from its 41-patient Phase 2b trial of OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma dated October 22, 2025.
- Lung-only second-or-greater metastatic event: 2-year OS 80.0% (8/10) with 2 lost to follow-up; 1-year EFS 50% (6/12).
- Lung-only first metastatic event: 2-year OS 73.8% (19/26) versus a 30% natural history comparator (p < 0.0001); 1-year EFS 28.6% (8/28) with 1 lost to follow-up.
The company highlighted a favorable safety profile versus institutional chemotherapy standards and said it plans regulatory meetings with the FDA, MHRA, and EMA as it prepares BLA and MAA filings under accelerated/conditional pathways.
OS Therapies (NYSE American: OSTX) announced the FDA granted a final Type C Meeting for OST-HER2 on December 11, 2025 to align on efficacy endpoints to support a BLA under the Accelerated Approval pathway for the Phase 2b metastatic osteosarcoma prevention program. The company expects biomarker data available Oct 10, 2025 to correlate immune activation with outcomes. The UK MHRA granted a pre-MAA meeting and the company targets a rolling review beginning November 2025, seeking aligned BLA/MAA timing via Project Orbis. The FDA/Osteosarcoma Institute workshop emphasized overall survival and canine model relevance.
OS Therapies (NYSE American: OSTX) reported statistically significant final 2-year overall survival (OS) data from its Phase 2b OST-HER2 trial in prevention/delay of recurrent, fully-resected pulmonary metastatic osteosarcoma. 75% (27/36) of treated patients achieved 2-year OS versus 40% historical control (p < 0.0001); 5 patients were lost to follow-up. 100% of patients with 12-month event-free survival reached 2-year OS. Biomarker correlation data are expected in November 2025. Regulatory filings targeted: MHRA MAA Dec 2025, FDA BLA Jan 2026, EMA MAA Q1 2026. Investor call set for Oct 13, 2025.
OS Therapies (NYSE: OSTX) reported a positive regulatory update after an October 6, 2025 meeting with the EMA rapporteur (MEB). The rapporteur indicated that overall survival (OS) with statistically significant, final two-year results may serve as a primary endpoint for a conditional marketing authorization (CMA). The rapporteur viewed safety, non-clinical, and CMC data as sufficient to support a CMA submission. The meeting advances formal EMA Scientific Advice expected in December 2025 and established a pathway for a confirmatory randomized program and potential label expansion. The UK MHRA granted an expedited Market Access Scientific Advice meeting to support the MAA process.
OS Therapies (NYSE: OSTX) announced participation in multiple October–November 2025 conferences and events to present corporate updates, engage in partnering and one-on-one meetings, and meet investors and stakeholders.
Key activities include: Cell and Gene Meeting on the Mesa (Oct 6-8, Phoenix) with CEO Paul Romness; Roth Healthcare (Oct 9, New York) with CBO Gerald Commissiong; an FDA/OSI osteosarcoma workshop (Oct 10, Washington, DC) with management and regulatory team; BIOFuture spotlight (Oct 13-15, New York); Daytime Emmy Awards attendance (Oct 17, Pasadena) for the documentary featuring OST-HER2 clinical trial participants; Maxim Growth Summit presentation (Oct 22, New York); and BIO-Europe partnering (Nov 3-5, Vienna).
OS Therapies (NYSE American: OSTX) has announced updates to its regulatory submission strategy for OST-HER2, targeting osteosarcoma treatment. The company plans to prioritize its UK MHRA conditional Marketing Authorisation Application (MAA) submission in December 2025, followed by the US FDA Biologics Licensing Application (BLA) in January 2026.
Following positive feedback from the UK MHRA's August 2025 Scientific Advice Meeting, the agency has accepted the use of historical control arm data. For the FDA submission, the company will propose using immune activation biomarker coupled with overall survival data as surrogate efficacy endpoints for Accelerated Approval, following positive End of Phase 2 Meeting outcomes.
The submissions are based on data from the completed Phase 2b clinical trial, currently in long-term follow-up phase, for OST-HER2 in preventing recurrent, fully resected, pulmonary metastatic osteosarcoma.
OS Therapies (NYSE American: OSTX), a clinical-stage biotech company, will participate in BioFuture 2025's Cancer Spotlight Panel on October 13, 2025 in New York City. The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 to the FDA in Q4 2025.
If approved before September 30, 2026, OS Therapies could receive a priority review voucher (PRV), which it plans to sell to fund further development of OST-HER2 for osteosarcoma and other HER2-positive cancers. The company has leveraged over $300 million in invested capital into its Listeria Platform technology, aiming to launch the first new osteosarcoma treatment in over 40 years.
The company's pipeline includes OST-504 for prostate cancer and OST-503 for non-small cell lung cancer and other solid tumors.
OS Therapies (NYSE American: OSTX) announced the completion of the last patient visit in its OST-504 Phase 1b clinical trial for biochemically recurrent prostate cancer. The trial enrolled 7 patients, with data expected in Q4 2025.
Additionally, the company will release updated 2-year overall survival data from its Phase 2b trial of OST-HER2 in osteosarcoma on October 10, 2025. OS Therapies is preparing to initiate a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in the coming weeks.
The company sees significant potential for OST-504 in prostate cancer treatment, noting that 1 in 8 men are diagnosed with prostate cancer, making it the second leading cause of male cancer deaths after lung cancer.
OS Therapies (NYSE American: OSTX) has achieved significant milestones in its development of OST-HER2 for treating recurrent, fully resected, pulmonary metastatic osteosarcoma. The FDA has confirmed OST-HER2's qualification as a Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number for Accelerated Approval submission.
The company's Phase 2b trial demonstrated statistically significant improvements with 35% vs. 20% in 12-month Event Free Survival and 66.6% vs. 40% in interim 2-year Overall Survival. OSTX has secured a U.S. commercial partnership with Eversana and raised $7.9M through warrant exchange financings, extending its cash runway into 2027. The company is preparing for potential U.S. launch in H1 2026.
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