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$CLDI - 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 - https://t.co/1iKiyag7OM
Upside: $DRRX +264% (BHC to acquire DRRX for upfront consideration of ~$63M at closing, with the potential for two additional net sales milestone payments of up to $350M) $CLDI +43% (receives FDA Fast Track Designation for CLD-201 (SuperNova), a First-In-Class Stem-Cell Loaded
$CLDI received FDA Fast Track designation for CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus, for the treatment of soft tissue sarcoma. See More Pre-market Movers 👇 https://t.co/cvaIwiyUPX $DRRX $SCNI $SLRX $FULC $SRPT $APLS $NVO $ADAP $NEO https://t.co/McJG9Ayeyn
Calidi Biotherapeutics said the U.S. Food and Drug Administration has granted Fast Track designation to CLD-201, an allogeneic adipose stem-cell-loaded oncolytic virus therapy under development for soft tissue sarcoma. The status allows Calidi to engage more frequently with the agency and makes the candidate eligible for priority review and, potentially, accelerated approval. Fast Track is reserved for products that address serious conditions with unmet medical needs. Calidi obtained Investigational New Drug clearance for CLD-201 on 17 April 2025 and plans to begin a first-in-human, open-label Phase 1 study that will evaluate safety, tolerability and preliminary efficacy in patients with soft tissue sarcoma, triple-negative breast cancer and head-and-neck squamous cell carcinoma.
