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) reported significant positive interim results from its Phase 2b trial of OST-HER2 for osteosarcoma treatment. The study showed 66.6% (18 out of 27) of OST-HER2 treated patients achieved 2-year overall survival compared to 40% in the historical control group, with statistical significance (p = 0.0046).
The FDA has issued a Biologics Licensing Application (BLA) number for OST-HER2 ahead of the anticipated BLA filing following the August 27, 2025 End of Phase 2 Meeting. The company is working to align approval metrics for RMAT designation, Breakthrough Therapy designation, and BLA via the Accelerated Approval Program.
Additionally, OS Therapies has been included in the Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes.
OS Therapies (NYSE American: OSTX) announced successful completion of a Scientific Advice Meeting with the UK's MHRA regarding OST-HER2, their immunotherapy treatment for recurrent, fully resected, pulmonary metastatic osteosarcoma. The company has submitted an Innovative Licensing and Access Pathway (ILAP) application to initiate the UK regulatory approval process.
MHRA recommended applying for Project Orbis to synchronize the UK Marketing Authorization Application with the FDA's Biologics Licensing Application Accelerated Approval Program. Additionally, the company secured a Scientific Advice Meeting with the Netherlands Medicines Evaluation Board for October 2025, advancing their EU-wide marketing authorization strategy via the Centralised Procedure.
OS Therapies (NYSE American: OSTX) has successfully closed a warrant exercise inducement and exchange offer, raising $4.2 million in gross proceeds. The funding extends the company's cash runway through 2026, beyond the September 2026 sunset date for the rare pediatric priority review voucher (PRV) program.
The proceeds will support regulatory efforts for OST-HER2 in treating pulmonary metastatic osteosarcoma, advance strategic alternatives for OS Animal Health subsidiary, complete the OST-504 prostate cancer study, and initiate AI-driven next-gen tADC product candidate modeling. The company plans to pursue a Biologics Licensing Authorization under the Accelerated Approval Program for OST-HER2 in human osteosarcoma within the next 18 months.
OS Therapies (NYSE American: OSTX) announced significant regulatory progress for its oncology programs. The company has scheduled an End of Phase 2 Meeting with FDA on August 27, 2025 to review its OST-HER2 program for recurrent, pulmonary metastatic osteosarcoma, aiming to begin a rolling BLA submission under Accelerated Approval.
The company has secured Scientific Advice Meetings with European regulators, including EMA and MHRA, pursuing marketing authorizations across Europe and the UK. Additionally, all patients in the Phase 1 clinical study of OST-504 for second-line prostate cancer have completed treatment, with data expected in H2 2025.
OS Therapies aims to obtain regulatory approval for OST-HER2 before the rare pediatric disease priority review voucher (PRV) program expires, planning to use potential PRV sale proceeds for commercialization and pipeline advancement.
OS Therapies (NYSE-A: OSTX) has achieved a significant milestone as the FDA granted an End of Phase 2 Meeting for its OST-HER2 program, targeting the prevention of recurrent, fully resected, pulmonary metastatic osteosarcoma. The meeting is scheduled for Q3 2025.
The company plans to pursue a Rolling Review process for its Biologics Licensing Application (BLA), potentially expediting the approval timeline. OST-HER2 has secured multiple FDA designations including Orphan Disease, Fast Track, and Rare Pediatric Disease Designation. If granted Accelerated Approval before September 30, 2026, OSTX could receive a Priority Review Voucher, with recent vouchers valued at $160 million.
OST-HER2 is an immunotherapy using HER2-bioengineered Listeria monocytogenes to target HER2-expressing cancer cells, with ongoing development in both human and canine applications.
OS Therapies (NYSE-A: OSTX) announced statistically significant positive clinical data for its immunotherapy candidate OST-HER2 in treating osteosarcoma. The Phase 2b trial showed that 35% of OST-HER2-treated patients achieved 1-year event free survival (EFS) compared to 20% in the historical control group (p=0.0194).
The safety profile demonstrated that 13 out of 40 patients experienced severe adverse events (SAEs), with only 7 patients having treatment-associated adverse events (TSAEs), all grade 3, with no grade 4 or 5 events reported. Notably, no patients discontinued the study due to adverse events.
The company is pursuing FDA Accelerated Approval and has submitted additional external control data following a Type D Meeting. OST-HER2 holds multiple FDA designations including Orphan Disease Designation, Fast Track, and Rare Pediatric Disease Designation. The UK's MHRA has agreed to support the company with data from its Clinical Practice Research Datalink to assist in potential worldwide marketing authorizations.
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.