Stock market today: S&P 500 drops for fifth day as focus shifts to Powell’s speech
NEW YORK - OS Therapies (OSTX), a biopharmaceutical company specializing in immunotherapy and Antibody Drug Conjugate (ADC) treatments with a market capitalization of $32.3 million, has announced the FDA’s agreement to review a surrogate endpoint for the potential Breakthrough Therapy Designation and Accelerated Approval of OST-HER2. This drug is aimed at preventing the recurrence of fully resected, lung metastatic osteosarcoma. According to InvestingPro analysis, the company maintains a favorable cash position relative to debt, though it’s currently experiencing rapid cash burn as it advances its pipeline.
The FDA has granted a written response-only meeting, with a response expected by mid-June 2025. The company plans to present its statistical analysis at the osteosarcoma conference MIB Factor on June 28, 2025.
Robert Petit, Chief Medical & Scientific Officer, expressed satisfaction with the FDA’s timely response, which aligns with the company’s plans to present at the MIB Factor conference. CEO Paul Romness anticipates a submission for OST-HER2 in early Q3 2025, with hopes for approval by year-end to provide the treatment to patients in early 2026.
OST-HER2 has already received Rare Pediatric Disease Designation from the FDA. If it secures a conditional Biologics License Application via Accelerated Review before September 30, 2026, OS Therapies could obtain a Priority Review Voucher, potentially selling it as seen in a recent transaction valued at $150 million in February 2025.
The market for osteosarcoma treatments was estimated at $1.2 billion in 2022, with a significant portion of patients developing lung metastasis after initial treatment. The company believes OST-HER2 could tap into a market opportunity exceeding $500 million, aiming to improve survival rates that currently stand at 59% for non-metastatic patients and 30% for those with pulmonary metastasis over three years. Analysts tracking the company on InvestingPro maintain a strong buy consensus, with price targets ranging from $6 to $20, though the stock has declined over 50% in the past six months. The platform offers 7 additional key insights about OS Therapies’ financial health and market position.
OST-HER2’s mechanism involves a bioengineered form of Listeria monocytogenes designed to trigger an immune response against HER2-expressing cancer cells. The therapy has been conditionally approved for canine osteosarcoma and is the subject of an upcoming movie, "Shelter Me: The Cancer Pioneers," which explores comparative oncology. With the company’s current financial health score rated as ’FAIR’ by InvestingPro, investors should monitor its progression toward commercialization.
OS Therapies continues to develop its next-generation ADCs and Drug Conjugates, featuring a proprietary technology that allows for multiple payloads per linker.
This news is based on a press release statement and provides an overview of OS Therapies’ current regulatory and development status for OST-HER2.
In other recent news, OS Therapies Inc has received shareholder approval for a significant stock issuance, as documented in a filing with the Securities and Exchange Commission. The approval allows the company to issue shares of common stock linked to the conversion of Series A Senior Convertible Preferred Stock and the exercise of certain warrants, potentially exceeding 20% of its outstanding common stock. Additionally, OS Therapies has acquired cancer immunotherapy assets from Ayala Pharmaceuticals, including late-stage and pre-clinical candidates, which expands its pipeline significantly. The acquisition enhances OS Therapies’ intellectual property and positions it in the growing cancer immunotherapy market. Furthermore, the company has announced progress with regulatory agencies for its OST-HER2 drug, aimed at treating osteosarcoma, and is preparing for a Biologics Licensing Application submission to the FDA in 2025. OS Therapies has also established a new subsidiary, OS Drug Conjugates, to leverage its patented platforms for tunable antibody drug conjugates, aiming to enhance shareholder value through potential joint ventures. The company postponed a special stockholder meeting due to a lack of quorum, rescheduling it for April 9, 2025, to address proposals outlined in their proxy statement. These developments highlight OS Therapies’ strategic efforts to advance its clinical pipeline and strengthen its market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.