OSTX Stock Forecast & Price Target

OS Therapies Inc. has made significant regulatory progress, particularly with the successful outcomes from meetings with the FDA and UK MHRA that clarify pathways for the accelerated approval of its lead candidate, OST-HER2, aimed at treating metastatic osteosarcoma. The company has gained full regulatory alignment for its Phase 2b program and received eligibility for Union-wide marketing authorization in Europe, indicating a favorable environment for future approvals. Additionally, the waiver of the application fee for the BLA filing by the FDA enhances OS Therapies' financial positioning and reduces barriers to market entry, strengthening the overall investment thesis around the company's prospects.

OS Therapies Inc faces significant challenges in its mission to develop effective treatments for osteosarcoma, as the disease's inherent characteristics—being immunologically "cold" and genetically unstable—limit the efficacy of current therapeutic approaches. The company's reliance on receptor-level HER2 inhibition is particularly concerning, given that osteosarcoma has shown poor responsiveness to this method. These fundamental adversities suggest a precarious outlook for the development and commercialization of new treatments, impacting future financial performance and investor confidence.