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

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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.

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