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) provided a global regulatory update for OST-HER2 in preventing recurrent, fully resected pulmonary metastatic osteosarcoma. The company submitted Non-Clinical and CMC BLA modules to the FDA end of January 2026 and expects clinical BLA submission after a Type D meeting in March 2026.
Additional biomarker data due Q1 2026; conditional MAA filings to MHRA and EMA expected by end Q1 2026. Confirmatory trial planned to start Q3 2026. OST-HER2 holds ODD, Fast Track and RPDD designations; potential PRV value cited at $200 million.
OS Therapies (NYSE American: OSTX) applauds reauthorization of the Rare Pediatric Disease Designation Priority Review Voucher program, extending PRV eligibility windows to September 30, 2026 through September 30, 2029. The change preserves potential PRV incentives for OST-HER2 and prompts re-evaluation of other listeria-based immunotherapy programs.
OST-HER2 holds FDA Orphan Disease Designation, FDA and EMA Fast Track, and FDA Rare Pediatric Disease Designation; a PRV would be available if Accelerated Approval is granted prior to September 30, 2029.
OS Therapies (NYSE: OSTX) has initiated a U.S. Biologics License Application (BLA) submission for OST-HER2 to prevent or delay recurrent, fully resected pulmonary metastatic osteosarcoma.
The company submitted Non‑Clinical and CMC modules and requested a Rolling Review. A Type D meeting is expected in March 2026 to review comparative oncology biomarker data, with the clinical BLA module targeted for submission by end of March 2026 and potential approval by September 30, 2026, which would preserve eligibility for a Priority Review Voucher under Rare Pediatric Disease Designation.
OS Therapies (NYSE American: OSTX) reported positive biomarker results from its Phase 2b OST-HER2 trial in fully resected, pulmonary metastatic osteosarcoma. Activation of interferon gamma pathway blood biomarkers correlated with overall survival, distinguishing patients with >=2-year survival from those <1 year. The biomarker strategy was pre-specified based on a 118-patient canine study published February 2025, supporting translational Comparative Oncology. The company is drafting a BLA and targets UK approval by end-Q2 2026, US by end-Q3 2026, and Europe by end-2026. OST-HER2 holds FDA ODD, FDA/EMA Fast Track, and FDA RPDD; PRV eligibility exists if Accelerated Approval occurs before Sept 30, 2026.
OS Therapies (NYSE: OSTX) announced that its wholly owned subsidiary OS Animal Health (OSAH) filed a Form S-1 to pursue an IPO on NYSE American or Nasdaq in 1H/2026. OSTX shareholders are expected to receive 1 OSAH share per 10 OSTX shares on a to-be-determined 1H/2026 record date. OSAH will focus on re-establishing USDA conditional approval and commercializing OST-HER2 for canine osteosarcoma and other HER2-positive animal cancers. OS Therapies reiterated a Jan 15, 2026 release date for Phase 2b OST-HER2 human biomarker data to support a planned BLA submission.
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.