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OS Therapies Inc. (OSTX) delivers innovative therapies targeting osteosarcoma and solid tumors through cutting-edge biopharmaceutical research. This page provides investors and medical professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.
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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.
OS Therapies (NYSE American: OSTX) announced the FDA granted a final Type C Meeting for OST-HER2 on December 11, 2025 to align on efficacy endpoints to support a BLA under the Accelerated Approval pathway for the Phase 2b metastatic osteosarcoma prevention program. The company expects biomarker data available Oct 10, 2025 to correlate immune activation with outcomes. The UK MHRA granted a pre-MAA meeting and the company targets a rolling review beginning November 2025, seeking aligned BLA/MAA timing via Project Orbis. The FDA/Osteosarcoma Institute workshop emphasized overall survival and canine model relevance.
OS Therapies (NYSE American: OSTX) reported statistically significant final 2-year overall survival (OS) data from its Phase 2b OST-HER2 trial in prevention/delay of recurrent, fully-resected pulmonary metastatic osteosarcoma. 75% (27/36) of treated patients achieved 2-year OS versus 40% historical control (p < 0.0001); 5 patients were lost to follow-up. 100% of patients with 12-month event-free survival reached 2-year OS. Biomarker correlation data are expected in November 2025. Regulatory filings targeted: MHRA MAA Dec 2025, FDA BLA Jan 2026, EMA MAA Q1 2026. Investor call set for Oct 13, 2025.
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