CDTX - Cidara on watch as FDA docs are released ahead of AdCom on antifungal drug
- Cidara Therapeutics ( NASDAQ: CDTX ) edged higher Friday morning after the FDA posted briefing documents on rezafungin, an antifungal treatment the company develops in partnership with Melinta Therapeutics ( OTCPK:MLNTQ ) and Mundipharma Medical.
- In September, the FDA accepted the company's marketing application for rezafungin under priority review for the treatment of candidemia and invasive candidiasis, granting Mar. 22, 2023, as the target action date.
- The publication comes as the FDA's Antimicrobial Drugs Advisory Committee Meeting is set to discuss the company's marketing application for rezafungin on Jan. 24.
- The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
- According to Stein, Cidara ( CDTX ) CEO Jeffrey Stein, if approved, rezafungin will become the first FDA-cleared therapy for invasive Candida infections in more than a decade.
- Seeking Alpha contributor William Meyers says Cidara ( CDTX ) stock has yet to reflect potential regulatory approvals for rezafungin in the U.S. and EU.
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Cidara on watch as FDA docs are released ahead of AdCom on antifungal drug