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-A: OSTX) received positive FDA feedback regarding its Phase 2b trial of OST-HER2, an immunotherapy treatment for preventing recurrence in pediatric lung metastatic osteosarcoma. The company has submitted requests for an End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD), with the meeting expected in Q3 2025.
OST-HER2 has received Rare Pediatric Disease Designation and could be eligible for a Priority Review Voucher worth approximately $160 million if granted conditional BLA via Accelerated Review before September 2026. The osteosarcoma treatment market is valued at $1.2 billion, with the company estimating OST-HER2's market opportunity at over $500 million.
OS Therapies (NYSE-A: OSTX) has announced a warrant exercise inducement and exchange offer for holders of its five-year warrants originally issued in December 2024. Current warrant holders can exercise their $1.12 warrants in exchange for new five-year warrants with a $3.00 exercise price.
The exercise of all Old Warrants would provide ~$8 million in gross proceeds, with $1.76 million already received, extending cash runway into H2 2026. The New Warrants include a forced exercise provision at $9.00 per share. The offer period runs from June 20 to July 10, 2025.
The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in Q3 2025 and will present additional Phase 2b trial data on June 28, 2025. If approved before September 2026, the company could receive a Priority Review Voucher, recently valued at $160 million.
The company announced positive data from its OST-HER2 Phase 2b clinical trial for preventing recurrent, fully resected, lung metastatic pediatric osteosarcoma. OS Therapies expects FDA feedback by mid-June 2025 regarding statistical analysis methods for pending Accelerated Approval.
Notable achievements include acquiring the listeria immunotherapy platform from Ayala Pharmaceuticals, adding three clinical stage and eight preclinical assets. A new manufacturing patent extends exclusivity protection until 2040. The company remains on track for Q3 2025 BLA filing for OST-HER2 and has sufficient funds to operate into mid-2026.
OS Therapies (NYSE: OSTX) announced positive data for their OST-HER2 treatment in canine osteosarcoma, showing promising results for potential human applications. The study demonstrated that combining OST-HER2 with palliative radiation in dogs with unresected osteosarcoma led to tumor arrest and extended survival of over 500 days in 5 out of 15 dogs.
A new publication in Molecular Therapy revealed that OST-HER2 induces strong immune responses from the first dose, correlating with metastasis prevention and long-term survival in dogs with resected osteosarcoma. The treatment was well-tolerated in both studies, suggesting potential for progression-free survival of primary osteosarcoma and prevention of metastatic disease.
The company plans to submit data to USDA for conditional approval of their new manufacturing process, aiming to begin sales in 2025, with full approval targeted for 2026. OS Therapies is pursuing Accelerated Approval for OST-HER2 in human osteosarcoma by year-end 2025.
OS Therapies (NYSE-A: OSTX) has completed the acquisition of Advaxis Immunotherapies' listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals, positioning itself as the world leader in this field. The acquisition includes:
- Three clinical-stage cancer immunotherapy candidates:
- OST-AXAL for HPV-associated cancers
- OST-503 for Non-Small Cell Lung Cancer & Glioblastoma
- OST-PSA for Prostate Cancer
Additionally, 8 pre-clinical immunotherapy candidates were acquired, targeting 30+ cancers. The company's lead asset, OST-HER2, targets approval by year-end 2025 for preventing recurrence in fully-resected, lung metastatic osteosarcoma. New manufacturing-based IP protects the platform until 2040. The global cancer immunotherapy market is valued at $126 billion (2023) and projected to exceed $296 billion by 2033.