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) 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.
OS Therapies (NYSE American: OSTX), described as a leader in gene-edited, listeria-based cancer immunotherapies, announced it will release first quarter 2026 financials and provide a business update on the morning of Monday, May 18, 2026.
OS Therapies (NYSE American: OSTX) appointed oncology industry veteran Dr. Craig Eagle as Chief Medical Advisor as it advances OST-HER2 for metastatic osteosarcoma.
According to OS Therapies, OST-HER2 holds ODD, FTD and RPDD from FDA, plus ODD, FTD and ATMP in Europe, and is being prepared for accelerated BLA and CMA filings across the U.S., U.K., Europe and Australia with approval decisions anticipated by year-end 2026.
OS Therapies (NYSE American: OSTX) received an updated coverage note highlighting progress for OST-HER2 in recurrent, fully resected pulmonary metastatic osteosarcoma.
EMA began rolling review of a Conditional Marketing Authorization dossier, regulators aligned on a 3-year overall survival endpoint, multiple 2026 data and meeting milestones are planned, and recent plus expected funding supports this catalyst calendar.
OS Therapies (NYSE: OSTX) announced that the EMA has initiated a rolling review of OST-HER2 for prevention of recurrence in fully resected pulmonary metastatic osteosarcoma and selected the company for EMA's Raw Data Pilot.
EMA, Australian TGA and UK MHRA/ATGA aligned on 3-year overall survival as the approvable efficacy endpoint and on seroconversion as a surrogate; Phase 3 initiation is planned in Australia in Q3 2026. OST-HER2 holds multiple orphan/accelerated designations and the company forecasts >$300M peak European sales and >$50M in 2027.
OS Therapies (NYSE American: OSTX) will host a conference call on April 30, 2026 at 8:30 AM ET to review data behind a Patent Cooperation Treaty application for an OST-HER2 pharmacodynamic biomarker (the OST-HER2 Immune Signature) proposed as a surrogate efficacy endpoint.
Company plans include filing a BLA under Accelerated Approval in H2 2026 in the U.S. for osteosarcoma, seeking CMAs in Europe, the U.K. and Australia, and pursuing regulatory meetings with FDA, EMA, MHRA and TGA. The company noted recent designations including ODD, FTD and RPDD, and referenced a publicly reported PRV sale value of $205 million in February 2026.