Welcome to our dedicated page for OS THERAPIES news (Ticker: OSTX), a resource for investors and traders seeking the latest updates and insights on OS THERAPIES 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) accepted a new FDA CDER BEST program meeting to review OST-HER2 pharmacodynamic biomarker data, in parallel with an FDA CBER Type B Statistical Methods Meeting on 2.5-year overall survival data.
These meetings support an Accelerated Approval BLA submission for OST-HER2 in osteosarcoma targeted for early Fall 2026.
OS Therapies (NYSE American: OSTX) issued its Q3 2026 outlook, highlighting regulatory, clinical and financial milestones for OST-HER2 in metastatic osteosarcoma and subsidiary OS Animal Health.
Key items include global regulatory alignment, plans for Phase 3 initiation, CMAA/BLA timelines, OSAH’s go-public steps, a new $10M LOC and cash runway into 2027.
OS Therapies (NYSE American: OSTX) appointed Chief Medical Advisor Dr. Craig Eagle to its Board of Directors and secured a $10 million line of credit backed by OS Therapies UK tax credits.
The company plans a late Q3 2026 confirmatory Phase 3 for OST-HER2, is pursuing accelerated approvals by year-end 2026, and, with the LOC and UK tax credits, expects cash runway into 2027.
OS Therapies (NYSE American: OSTX) provided a U.S. regulatory update on its Metastatic Osteosarcoma Program and OST-HER2 BLA strategy under the FDA Accelerated Approval pathway.
The company has requested a Type B Meeting to review 2.5-year overall survival data and seek FDA alignment on 3-year overall survival as an approvable efficacy endpoint, matching agreements reached with MHRA and EMA for conditional approvals. Pharmacodynamic biomarker data have been submitted to the FDA BEST program as potential surrogate efficacy data, and FDA and EMA have begun joint dossier coordination to evaluate early market access. OS Therapies also plans to discuss using its OST-400 retrospective natural history database as a synthetic control arm, alongside pooled historical controls, and to review pending Rolling Review, RMAT and Breakthrough Therapy designation requests.
OS Animal Health (NYSE:OSTX) reported peer-reviewed Phase 2 data for OST-HER2 plus palliative radiation as frontline treatment in canine osteosarcoma. Median survival was 159 vs. 124 days for radiation alone, and 2-year survival was 20% vs. 1%. The company plans a USDA meeting and a Q3 2026 crowdfunding ahead of a proposed go-public transaction and share distribution to OS Therapies shareholders.
OS Therapies (NYSE American: OSTX) reported global regulatory alignment on the Phase 3 trial design of OST-HER2 for fully resected, pulmonary metastatic osteosarcoma. FDA, EMA, MHRA and TGA have agreed on CMC plans and use of a pharmacodynamic biomarker as a surrogate efficacy endpoint.
The confirmatory Phase 3 trial is expected to start in Australia in the third quarter of 2026, supporting potential year-end regulatory decisions and possible 2027 patient access. OST-HER2 holds multiple FDA and EMA/MHRA designations, and EMA has begun rolling review while a BLA filing with FDA is underway.
OS Therapies (NYSE American: OSTX) reported Phase 2b data for OST-HER2 in fully resected pulmonary metastatic osteosarcoma, showing 75% 2.5-year overall survival vs. 47% pooled historical control (p=0.003), with no new deaths since the 2-year analysis (75% vs. 60%, p=0.034).
Updated efficacy and biomarker data are being added to regulatory dossiers as the company pursues early market authorizations in the U.S., U.K., Europe and Australia in late 2026, supported by aligned EMA/TGA use of upcoming 3-year overall survival and a planned confirmatory Phase 3 starting late Q3-2026.
OS Therapies (NYSE American: OSTX) announced the publication of four Drug Discovery World articles on OST-HER2 and osteosarcoma, covering treatment futures, comparative oncology, regulatory science and accelerated approval. The company plans to present 2.5-year overall survival data from its Phase 2b OST-HER2 trial at ASCO 2026.
OST-HER2 holds ODD, FTD and RPDD from the FDA, plus ODD, FTD and ATMP from the EMA. OS Therapies is seeking a BLA under the U.S. Accelerated Approval Program in the second half of 2026 and related conditional approvals in Europe, the U.K. and Australia.
OS Therapies (NYSE American: OSTX) plans to attend several key medical, financial and industry conferences in May and June 2026.
The company will share 2.5-year overall survival data, hold partnering and investor meetings, participate in a BIO panel, and present additional data.
OS Therapies (NYSE American: OSTX) reported Q1 2026 results and a business update focused on lead candidate OST‑HER2 in metastatic osteosarcoma. The company raised $11.2 million in Q1 and early Q2 2026 and expects cash runway into 2027.
OS Therapies reported a Q1 2026 net operating loss of $10.396 million, or $0.27 per share. The company advanced regulatory filings, including EMA rolling review of a conditional MAA for OST‑HER2, and progressed an S‑1 for the proposed go‑public transaction of subsidiary OS Animal Health.