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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.
Access verified information about OSTX's pipeline progress, including clinical trial results, FDA communications, and research partnerships. Our curated news collection helps stakeholders track advancements in pediatric oncology treatments and therapeutic innovations.
Discover updates across key categories: new drug applications, trial phase transitions, scientific collaborations, and patent developments. All content undergoes rigorous verification to ensure alignment with medical reporting standards and financial disclosure requirements.
Bookmark this page for streamlined access to OSTX's latest developments in bone cancer research. Regularly updated to reflect the company's progress in addressing critical unmet needs through targeted therapeutic solutions.
OS Therapies (NYSE American: OSTX) has announced updates to its regulatory submission strategy for OST-HER2, targeting osteosarcoma treatment. The company plans to prioritize its UK MHRA conditional Marketing Authorisation Application (MAA) submission in December 2025, followed by the US FDA Biologics Licensing Application (BLA) in January 2026.
Following positive feedback from the UK MHRA's August 2025 Scientific Advice Meeting, the agency has accepted the use of historical control arm data. For the FDA submission, the company will propose using immune activation biomarker coupled with overall survival data as surrogate efficacy endpoints for Accelerated Approval, following positive End of Phase 2 Meeting outcomes.
The submissions are based on data from the completed Phase 2b clinical trial, currently in long-term follow-up phase, for OST-HER2 in preventing recurrent, fully resected, pulmonary metastatic osteosarcoma.
OS Therapies (NYSE American: OSTX), a clinical-stage biotech company, will participate in BioFuture 2025's Cancer Spotlight Panel on October 13, 2025 in New York City. The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 to the FDA in Q4 2025.
If approved before September 30, 2026, OS Therapies could receive a priority review voucher (PRV), which it plans to sell to fund further development of OST-HER2 for osteosarcoma and other HER2-positive cancers. The company has leveraged over $300 million in invested capital into its Listeria Platform technology, aiming to launch the first new osteosarcoma treatment in over 40 years.
The company's pipeline includes OST-504 for prostate cancer and OST-503 for non-small cell lung cancer and other solid tumors.
OS Therapies (NYSE American: OSTX) announced the completion of the last patient visit in its OST-504 Phase 1b clinical trial for biochemically recurrent prostate cancer. The trial enrolled 7 patients, with data expected in Q4 2025.
Additionally, the company will release updated 2-year overall survival data from its Phase 2b trial of OST-HER2 in osteosarcoma on October 10, 2025. OS Therapies is preparing to initiate a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in the coming weeks.
The company sees significant potential for OST-504 in prostate cancer treatment, noting that 1 in 8 men are diagnosed with prostate cancer, making it the second leading cause of male cancer deaths after lung cancer.
OS Therapies (NYSE American: OSTX) has achieved significant milestones in its development of OST-HER2 for treating recurrent, fully resected, pulmonary metastatic osteosarcoma. The FDA has confirmed OST-HER2's qualification as a Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number for Accelerated Approval submission.
The company's Phase 2b trial demonstrated statistically significant improvements with 35% vs. 20% in 12-month Event Free Survival and 66.6% vs. 40% in interim 2-year Overall Survival. OSTX has secured a U.S. commercial partnership with Eversana and raised $7.9M through warrant exchange financings, extending its cash runway into 2027. The company is preparing for potential U.S. launch in H1 2026.
OS Therapies (NYSE American: OSTX), a clinical-stage cancer immunotherapy and antibody drug conjugate biotech company, has announced its participation in three major investor conferences in September 2025. The company will attend the Cantor Global Healthcare Conference (Sept 3-5), the H.C. Wainwright Global Investment Conference (Sept 8-10), and the Lake Street Capital Markets BIG9 Conference (Sept 11).
Management will be available for meetings with institutional investors and brokers at all events, with a pre-recorded presentation available for H.C. Wainwright conference participants.
OS Therapies (NYSE:OSTX) has provided a significant update following its End of Phase 2 Meeting with the FDA regarding OST-HER2 for recurrent, fully resected, pulmonary metastatic osteosarcoma. The company plans to begin a rolling Biologics Licensing Application (BLA) submission in September 2025.
Key achievements include positive clinical data with statistically significant 12-month Event Free Survival (p=0.0197) and interim 2-year overall survival data (p=0.0046) from its 40-patient Phase 2b trial. The FDA identified no significant safety concerns and agreed on non-clinical and CMC-related matters. The company is awaiting FDA guidance on efficacy endpoints and statistical analysis plans that would support either Accelerated Approval or full marketing authorization.
A crucial FDA/OSI public meeting is scheduled for October 10, 2025, focusing on advancing osteosarcoma drug development pathways. The company is also developing the OST-400 database to potentially support a synthetic control arm for the trial.
OS Therapies (NYSE American: OSTX) has successfully completed a warrant exchange offer with holders of outstanding warrants originally issued in December 2024. The transaction raised $3.7 million in gross proceeds through the exercise of warrants with a $1.12 per share exercise price.
The new warrants issued have an exercise price of $3.00 per share with a forced exercise provision triggered when the stock trades above $9.00. The proceeds will primarily fund commercial preparations for OST-HER2, targeting prevention of recurrent pulmonary metastatic osteosarcoma. The company now has funding extended into 2027, with potential for additional $20 million if the forced exercise provision is triggered.
OS Therapies (NYSE American: OSTX), a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, has announced plans to provide a comprehensive update following their End of Phase 2 Meeting with the FDA regarding OST-HER2. The update, scheduled for September 2, 2025, will detail the regulatory pathway for potential approval of OST-HER2 in treating recurrent, fully resected, pulmonary metastatic osteosarcoma.
The company described their August 27 meeting with the FDA as "highly constructive," suggesting positive developments in their clinical program for this rare cancer treatment.
OS Therapies (NYSE American: OSTX) has announced the termination of its Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund, LLC - Series 3, effective August 26, 2025. The company recently secured $4.2 million in gross proceeds through a warrant exercise inducement and exchange offering, providing operational funding through mid-2026.
The company has completed the treatment phases of two clinical trials: the Phase 2b OST-HER2 trial in osteosarcoma and the Phase 1b OST-504 trial in prostate cancer. With reduced projected monthly expenses in H2 2025, OS Therapies will focus on pursuing approval for OST-HER2 while evaluating development options for OST-504.
OS Therapies (NYSE American: OSTX) reported significant progress in Q2 2025 for its lead candidate OST-HER2 in treating osteosarcoma. The company announced statistically significant results from its Phase 2b trial, with 12-month Event Free Survival (35% vs. 20%, p = 0.0197) and interim 2-year Overall Survival (66.6% vs. 40%, p = 0.0046).
Key developments include FDA's confirmation of OST-HER2's RMAT biological qualification, BLA number issuance, and a scheduled End of Phase 2 Meeting for August 27, 2025. The company secured a $4.2 million capital raise extending runway into mid-2026 and partnered with Eversana for U.S. commercialization, targeting launch in H1 2026.
Financial results showed a Q2 2025 net operating loss of $4.537 million ($0.19 per share) compared to $1.557 million ($0.26 per share) in Q2 2024. The company aims to submit BLA in late Q3 2025 and could receive regulatory approval by year-end 2025.
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