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 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-A: OSTX) announced its immunotherapy treatment OST-HER2 will be featured in the documentary 'Shelter Me: The Cancer Pioneers', focusing on canine comparative oncology. The film explores the similarities between cancer treatments in dogs and humans, particularly for rare cancers.
OST-HER2 is an experimental immunotherapy for osteosarcoma that uses a bioengineered form of Listeria monocytogenes bacteria targeting HER2-expressing cancer cells. The documentary highlights the 96% genetic similarity between human and canine osteosarcoma, underlining the importance of comparative oncology research.
The film will premiere at AMC Century City in Los Angeles on April 3, 2025, followed by streaming availability on PBS platforms in May. The documentary features scientists from various institutions including the National Cancer Institute, University of Pennsylvania, University of Illinois, University of Wisconsin, and Colorado State University.
OS Therapies (NYSE-A: OSTX), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, has announced its participation in The Jones Healthcare and Technology Innovation Conference. The event will take place on April 8-9, 2025 at the Venetian Resort in Las Vegas.
CEO Paul Romness and CBO Gerald Commissiong will be available for meetings with registered investors during the conference. The event, hosted by JonesTrading Institutional Services, , aims to connect leading healthcare and technology companies with institutional investors and opinion leaders.
The conference will feature:
- Expert-led panels
- Corporate presentations
- Fireside chats
- One-on-one meetings
OS Therapies (NYSE-A: OSTX) has secured a presentation slot at the MIB Agents Factor Osteosarcoma Conference in Salt Lake City (June 26-28, 2025) to showcase data from their Phase 2b clinical trial of OST-HER2. The trial focuses on preventing recurrent, fully resected, lung metastatic osteosarcoma.
The company will present comparative data with a regulatorily compliant synthetic control group, which will be used for their upcoming FDA Biologics License Application (BLA). The company plans to submit the BLA in Q2 2025, with potential approval expected in Q4 2025.
OST-HER2 has received multiple regulatory designations including:
- Rare & Pediatric Disease Designation from FDA
- Fast Track and Orphan Drug Designations from both FDA and EMA
OS Therapies (NYSE-A: OSTX) has scheduled a Scientific Advice Meeting with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in Q3 2025 to discuss the Innovative Licensing and Access Pathway for its OST-HER2 immunotherapy. This therapy aims to prevent metastases recurrence in osteosarcoma patients.
The company reported positive Phase 2b data in January 2025, showing statistically significant results in the primary endpoint of 12-month event-free survival. The meeting positions OS Therapies to potentially launch OST-HER2 in the UK market in 2025.
As a UK reference country approval could facilitate approvals in multiple nations including Australia, Canada, and several European countries. The treatment has already received Fast Track and Orphan Drug designations from the European Medicines Agency.
Calidi Biotherapeutics (NYSE:CLDI) will be featured on Bloomberg TV's RedChip Small Stocks, Big Money™ show on March 1, 2025, at 7 p.m. ET. During the interview, CFO Andrew Jackson discusses the company's oncolytic virotherapy (OV) platforms for cancer treatment.
The company's technology utilizes stem cells to protect, amplify, and enhance oncolytic viruses for targeting cancer cells. Their pipeline includes CLD-101, currently in Phase 1/1b trials with upcoming Phase 1b/2 study, and CLD-201 targeting Phase 1 initiation in 2025. The company estimates its addressable U.S. market at $13-15 billion.
OS Therapies (OSTX) announces an exclusive live investor webinar scheduled for February 27, 2025, at 4:15 p.m. ET. The event will feature presentations from CEO Paul Romness and CBO Gerald Commissiong, focusing on the company's pipeline developments.
The company's lead candidate, OST-HER2, has shown significant improvements in 12-month event-free survival for recurrent, fully resected metastatic osteosarcoma, positioning it for potential accelerated FDA approval. Their proprietary Tunable Antibody Drug Conjugate (tADC) platform, featuring SiLinker™ technology, has demonstrated preclinical efficacy in ovarian and HER2-positive cancers.
The company highlights potential value drivers including upcoming clinical and regulatory milestones, licensing agreement revenues, and a possible Priority Review Voucher valued at approximately $150 million.
OS Therapies (NYSE-A: OSTX) announced positive results from their Phase 2b clinical trial of OST-HER2, a HER2-targeted immunotherapy for recurrent osteosarcoma with lung metastases. The study demonstrated statistically significant results in the primary endpoint, with 33.3% 12-month Event Free Survival (EFS) compared to 20% historical control (p=0.0158).
The trial included 39 evaluable patients aged 12-39 years across 21 centers, receiving 16 doses over 48 weeks. Interim analysis showed promising overall survival rates, with 91% 1-year survival and 61% 2-year survival compared to historical controls of 80% and 40% respectively. Notably, all patients achieving 12-month EFS remain alive.
Subgroup analyses revealed higher EFS rates in females (47%) versus males (20%), and in patients with multiple lung resections (55%) versus single resection (25%). The company is preparing to engage with FDA for an accelerated approval pathway, as there are currently no approved treatments for this indication.
OS Therapies (NYSE-A: OSTX) has announced the formation of a new subsidiary, OS Drug Conjugates (OSDC), alongside strategic initiatives to leverage its patented silicone dioxide-based, pH-sensitive tunable antibody drug conjugates (tADC) and drug conjugates (tDC) platforms. The company is pursuing discussions with clinical-stage ADC therapeutics companies across the U.S. and China to establish joint ventures, with plans to spin these JVs into standalone public companies.
The company's proprietary technology utilizes SiLinkers™, pH-sensitive silicon-based linkers that connect targeting antibodies with therapeutic agents. This system is designed to release therapeutic agents specifically within tumors and their microenvironment, where pH levels are lower, maximizing treatment effectiveness while reducing harm to healthy cells.
According to BCC Research, the global antibody-drug conjugates market is projected to grow from $10.8 billion in 2023 to $47.0 billion by 2029, representing a CAGR of 28.4%.
OS Therapies (NYSE-A: OSTX) received a USPTO Notice of Allowance for a patent covering OST-HER2 commercial manufacturing methods, with market exclusivity extended into 2040. The company is preparing for FDA discussions following its Phase 2b clinical trial in osteosarcoma, aiming for BLA submission and potential FDA approval in 2025.
The company completed a $7.1 million financing in January 2025, providing capital into mid-2026. OST-HER2 holds rare pediatric disease, fast-track, and orphan drug designations. Phase 1 trials in HER2-expressing cancers showed promising results, including a 78% reduction in tumor size in breast cancer models and 65% reduction in metastatic cells.
The company targets the osteosarcoma market, estimated at $1.2 billion in 2022, with an expected $500 million opportunity for OST-HER2. The breast cancer market, valued at $29.2 billion in 2023, presents an additional $1 billion opportunity.
OS Therapies (NYSE-A: OSTX) has announced steps toward commercial manufacturing of OST-HER2, marking progress in its development of cancer immunotherapies. The company has secured agreements for commercial manufacturing as it prepares for a potential Biologics Licensing Authorization (BLA) submission to the FDA.
The announcement follows the completion of a Phase 2b trial testing OST-HER2 for preventing lung metastatic osteosarcoma recurrence. The company is currently organizing trial data for an upcoming Type B or Type C meeting with the FDA, after which it plans to submit a BLA application for accelerated or conditional approval consideration.
FAQ
What is the current stock price of OS THERAPIES INCORPORATED (OSTX)?
What is the market cap of OS THERAPIES INCORPORATED (OSTX)?
