CDTX - Cidara jumps 17% after FDA AdCom nod for antifungal drug
Cidara Therapeutics ( NASDAQ: CDTX ) climbed ~17% pre-market Wednesday after the company announced that a group of experts at the FDA voted in favor of its antifungal therapy rezafungin.
The agency's Antimicrobial Drugs Advisory Committee evaluated rezafungin as a treatment for candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
The panel has voted 14 to 1 that the company, with its marketing application, has given sufficient data to support "a favorable benefit-risk assessment for a limited use indication for rezafungin," Cidara ( CDTX ) said.
The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision which, in the case of rezafungin, is expected on or before Mar. 22.
If approved, rezafungin will be the first FDA-approved therapy for candidemia and invasive candidiasis in over a decade.
Cidara ( CDTX ) develops the treatment in partnership with Melinta Therapeutics ( OTCPK:MLNTQ ) and Mundipharma Medical.
The company shares plunged last week after the FDA posted briefing documents on rezafungin ahead of the AdCom meeting.
Read: Seeking Alpha contributor William Meyers thinks Cidara ( CDTX ) has yet to reflect potential U.S. and EU regulatory approvals for rezafungin.
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Cidara jumps 17% after FDA AdCom nod for antifungal drug