Calidi Biotherapeutics Stock Soars 68% on FDA Fast Track Designation

On July 29, 2025, Calidi's stock surged by 68% in pre-market trading, marking a significant milestone for the biotechnology company.

Calidi Biotherapeutics, Inc. announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its allogeneic adipose stem-cell loaded oncolytic virus, CLD-201, also known as SuperNova. This designation is granted to products that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The Fast Track designation will facilitate the development and expedite the review of CLD-201, providing Calidi with more frequent interactions with the FDA and potential eligibility for priority review and accelerated approval.

CLD-201 is designed to treat soft tissue sarcoma and has shown promise in preclinical animal models. The company's Chief Medical Officer, Guy Travis Clifton, M.D., highlighted the significance of this designation, stating that it underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201. The planned Phase 1 trial for CLD-201 will evaluate its safety, tolerability, and efficacy in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.

Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies that can deliver genetic medicines to sites of disease. The company's proprietary Redtail platform is designed to shield viral vectors from immune detection, allowing for systemic delivery and distal sites of disease in oncology and potentially other indications. The lead candidate from the Redtail platform is currently in IND-enabling studies, targeting non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need.