QualityStocksNewsBreaks – Calidi Biotherapeutics Inc. (NYSE American: CLDI) Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma
Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company developing targeted genetic medicine delivery therapies, announced that the U.S. Food and Drug Administration granted Fast Track designation to CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus for treating soft tissue sarcoma. The designation provides opportunities for expedited development, including priority review and accelerated approval. CLD-201, which received IND clearance in April, will enter a Phase 1 trial evaluating safety and efficacy in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Chief Medical Officer Guy Travis Clifton, M.D., said the milestone validates CLD-201’s potential to deliver durable,…
