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Calidi Biotherapeutics Receives FDA Fast Track Designation for CLD-201 (SuperNova), a First-In-Class Stem-Cell Loaded Viral Therapy for the Treatment of Patients with Soft Tissue Sarcoma
SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company’s allogeneic adipose stem-cell loaded oncolytic virus for the treatme
About this update from Calidi Biotherapeutics, Inc.
[{"type":"image","alt":"Calidi Biotherapeutics, Inc","displaySize":"","headline":null,"caption":"Calidi Biotherapeutics, Inc","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":93,"url":"https://media.zenfs.com/en/globenewswire.com/8983e19176ab43568fb63e4ece5ad7a1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/TVVsA9n31LT1YQqkVdlDAw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/8983e19176ab43568fb63e4ece5ad7a1","width":300,"height":93}},"lazy":false},{"type":"text","content":"SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company’s allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma.","length":546,"tagName":"p"},{"type":"text","content":"Fast Track designation is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. CLD-201 will benefit from this designation through more frequent interactions with the FDA along with potential eligibility for priority review and accelerated approval.","length":440,"tagName":"p"},{"type":"text","content":"Guy Travis Clifton, M.D., Chief Medical Officer of Calidi commented, “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201. We believe CLD-201 has the potential to provide durable and transformational treatment to patients with sarcoma as well as patients with other advanced tumor types. We want to thank the FDA for its support and partnership and look forward to continued collaboration with the agency.”","length":588,"tagName":"p"},{"type":"text","content":"FDA Investigational New Drug (IND) clearance for CLD-201 was announced on April 17, ...