The FDA has signed off Cidara Therapeutics Inc's (NASDAQ: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.
