CDTX - Cidara announces FDA acceptance of its request to study the flu candidate

Cidara Therapeutics (NASDAQ:CDTX) is trading ~3% higher in the pre-market on Monday after the company announced that the FDA accepted its Investigational New Drug (IND) application for the lead flu drug-Fc conjugate (DFC), CD388. Designed based on the company’s Cloudbreak platform, CD388 is undergoing studies for the protection against seasonal and pandemic influenza in a single seasonal dose. “Receiving this clearance to advance CD388 into the clinic represents an important milestone for Cidara and our Cloudbreak platform,” Cidara (CDTX) CEO Jeffrey Stein remarked. The Phase 1 trial for the candidate is expected to begin before the end of the current quarter targeting healthy volunteers. Following a partnership with Janssen Pharmaceuticals of Johnson & Johnson (NYSE:JNJ), Cidara (CDTX) is responsible for the development and manufacturing of CD388 into the clinic and through Phase 2a development. Janssen will fund the Phase 1-related development costs and lead the late-stage development, production, registration, and global commercialization.

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Cidara announces FDA acceptance of its request to study the flu candidate