CDTX - Cidara extends gains ahead of FDA decision on antifungal therapy
2023-03-22 08:17:48 ET
- After reaching a 52-week high in the previous session, Cidara Therapeutics ( NASDAQ: CDTX ) continued to trade higher in the pre-market Wednesday as the biotech awaits the FDA decision on its antifungal therapy rezafungin.
- In September, the FDA accepted the company's marketing application for rezafungin under priority review as a treatment for candidemia and invasive candidiasis, granting Mar. 22, 2023, as the target action date.
- Early this year, an independent group of experts at the agency voted 14 to 1 to endorse rezafungin as a treatment for candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
- The FDA's advisory committees issue non-binding recommendations. However, the regulator typically follows them before making a final decision.
- Rezafungin is a collaboration between Cidara ( CDTX ), Melinta Therapeutics ( OTCPK:MLNTQ ), and Mundipharma Medical.
- Read: Seeking Alpha contributor Stephen Ayers attempts to develop a proposed indication label for rezafungin.
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Cidara extends gains ahead of FDA decision on antifungal therapy