Results

Cidara shares tank after lead antifungal program flops in PhII

Cidara CEO Jeff Stein

Shares of Cidara Therapeutics $CDTX tanked Tuesday morning after the upstart antifungal biotech said its lead program foundered in Phase II.

Investigators went looking for efficacy data on gel and ointment formulations of their CD101 for acute vulvovaginal candidiasis, but found that it had significantly lower cure rates compared to oral fluconazole, which is commonly used to treat fungal infections. There might have been a way forward, but CEO Jeff Stein opted to continue the work on an IV program for CD101 in candidemia and drop the topical effort while refocusing the pipeline.

Cidara’s shares were blasted by the setback, plunging 41%. Investors have little tolerance for R&D failures these days.

“We are obviously disappointed with these results, which did not demonstrate the highly potent antifungal properties of CD101 against Candida we saw in preclinical animal models of VVC. While we believe that an improved topical formulation of CD101 could improve outcomes, at this time we have no plans for further development of CD101 topical in VVC,” said Stein, a veteran in the field. “We would like to thank the investigators and the patients who participated in this trial. This does not impact our development of CD101 IV for the treatment of candidemia and invasive candidiasis, for which animal models are well established and highly predictive of clinical outcomes.”


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