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: OSTX) announced a warrant exercise inducement and exchange with nine accredited investors that generated $7.53 million in gross proceeds. The company said all nine holders agreed to exercise or prefund their existing warrants, providing runway into 2027. Net proceeds are planned to support regulatory filings and commercial preparation for OST-HER2 in prevention or delay of recurrent pulmonary metastatic osteosarcoma in the U.S., U.K., and EU, and to fund preparations for a proposed spinoff of its wholly owned subsidiary OS Animal Health. The company reiterated intent to file a BLA by end of January 2026 and to submit a MAA to MHRA by end-February 2026 and to EMA by March 2026, with target approval windows across 2026. OST-HER2 holds FDA Orphan Disease, FDA/EMA Fast Track, and FDA Rare Pediatric Disease designations; a Priority Review Voucher may be available if Accelerated Approval is received before September 30, 2026.
OS Therapies (NYSE: OSTX) outlined a H1 2026 corporate outlook focused on regulatory submissions and clinical readouts. The company plans a U.S. BLA filing for OST-HER2 under Accelerated Approval by end of January 2026, with UK and EU MAA submissions expected by end of February and March 2026. Phase 2b biomarker data from the metastatic osteosarcoma program is expected the week of the J.P. Morgan Healthcare Conference 2026. The company expects multiple regulator meetings in H1 2026 and provisional approval timing of UK Q2, US Q3, EU Q4 2026. OS Animal Health confidential SEC filing expected early January 2026. OST-504 data delayed to Q1 2026; End of Phase meetings for OST-504 and OST-503 expected in Q2 2026.
OS Therapies (NYSE American: OSTX) reported a successful Type C meeting with the FDA about its Phase 2b OST-HER2 program to prevent or delay recurrent, fully resected pulmonary metastatic osteosarcoma.
FDA confirmed that single-arm data in ultra-rare osteosarcoma could support a BLA via Accelerated Approval, while a randomized confirmatory study in an expanded setting would be required and must be underway before full approval. The company reiterated intent to file a BLA by end of January 2026 and expects immune activation biomarker analysis data to be released during the week of the JP Morgan Healthcare Conference, January 2026.
OS Therapies (NYSE: OSTX) reported a successful pre-MAA meeting with the UK MHRA on December 9, 2025, for the Phase 2b OST-HER2 program targeting prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.
The company said it achieved alignment on non-clinical, CMC and post-market confirmatory study design, advanced a biomarker correlation as a pre-specified surrogate efficacy endpoint tied to 2-year overall survival, and reiterated a target to submit a conditional MAA by end of January 2026. OS Therapies is awaiting input from a December 11, 2025 FDA Type C meeting before initiating the biomarker analysis for potential Accelerated Approval support.
OS Therapies (NYSE American: OSTX) announced regulatory progress for OST-HER2 and its Metastatic Osteosarcoma Program on December 5, 2025.
The U.S. FDA granted a waiver of the BLA application fee for BLA 125867 (OST-HER2). The EMA CHMP granted Union Marketing Authorisation eligibility for OST-HER2 in prevention or delay of recurrent, fully‑resected pulmonary metastatic osteosarcoma and requested an accelerated MAA submission by February 28, 2026. The company completed pre-meeting submissions to the UK MHRA for a pre‑MAA meeting on Dec 8, 2025 and scheduled a Type C meeting with the FDA on Dec 11, 2025. OS Therapies intends to review commercial CMC, non‑clinical considerations, and propose a global confirmatory study to support conditional/accelerated approvals.
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.