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 American: OSTX) announced that the WHO INN Expert Committee approved 'daznelimgene lisbac' as the International Nonproprietary Name for its HER2-targeted Listeria monocytogenes cancer immunotherapy candidate OST-HER2.
The company said it will transition to the INN alongside the OST-HER2 name and quoted management stating the program is on track to receive regulatory feedback from U.S., U.K., and European authorities in December 2025 and to begin filing for regulatory approvals in January 2026.
OS Therapies (NYSE American: OSTX) advanced clinical, regulatory, and commercial milestones in 3Q25 for OST-HER2 in recurrent, fully resected pulmonary metastatic osteosarcoma.
Key facts: a 41-patient Phase 2b showed 2-year overall survival 75% versus 40% historical control and 100% 2-year survival for patients event-free at 12 months. Management targets UK pre-MAA in December and FDA Type C then filings in January 2026, expects PRV monetization in 2026 and commercial OST-HER2 revenues in early 2027. The company plans a 1H26 spinoff of OS Animal Health with direct equity to OSTX shareholders. Quarter-end cash was ~$1.9M with a $6.9M net loss; post-quarter proceeds of $7.8M plus an ATM extend runway into late 2026.
OS Therapies (NYSE American: OSTX) announced plans to spin off its wholly owned subsidiary OS Animal Health (OSAH) as a standalone public company, targeting a U.S. national exchange listing in H1 2026. Shareholders are expected to receive direct equity participation in OSAH if the transaction proceeds. The company cited prior USDA conditional approval of canine OST-HER2, ongoing regulatory engagement including the FDA's Aug 18, 2025 draft guidance, and a forthcoming seminal publication supporting OST-HER2. Management has held preliminary NYSE discussions and engaged investors, KOLs, and potential manufacturers.
OS Therapies estimates a U.S. OST-HER2 addressable opportunity > $150M and references veterinary oncology market growth to $4.77B by 2034.
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.