FDA Clears Cidara Therapeutics' Phase 1 Trial For Immunotherapeutic Antiviral For Influenza

The FDA has signed off Cidara Therapeutics Inc's CDTX Investigational New Drug (IND) application for its lead flu drug-Fc conjugate (DFC), CD388 for influenza.

• CD388 is a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and treatment of seasonal and pandemic influenza, added the Company.
• Cidara intends to initiate a Phase 1 study in healthy volunteers before the end of the current quarter.
• Related: Cidara Therapeutics Stock Slides Despite Acing Rezafungin Trial In Fungal Infection.
• In April 2021, Cidara announced an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals Inc to develop and commercialize Cidara's Cloudbreak DFCs to prevent and treat seasonal and pandemic influenza. 
• Under the collaboration, Cidara is responsible for developing and manufacturing CD388 into the clinic and through Phase 2a clinical development.
• Janssen is responsible for late-stage development, manufacturing, registration, and global commercialization. 
• Janssen will fund the Phase 1 trial-related development costs and future research, development, manufacturing, and commercialization for CD388.
• Price Action: CDTX shares are down 0.12% at $0.80 during the market session on the last check Monday.