Shares of biotechnology company Cidara Therapeutics (NASDAQ:CDTX) are on the upmove today after the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted in favor of a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis.
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The advisory committee’s recommendation for the FDA’s approval of the treatment is a major boost for Cidara’s aim to offer a once-weekly treatment alternative for candida infections. Significantly, there has been no new approved drug for the indication in more than 10 years.
But there’s more, rezafungin demonstrated statistical non-inferiority against the current standard of care (caspofungin).
At the same time, the FDA does not need to abide by the committee’s recommendations and now March 22 has been set as the prescription drug user fee act (PDUFA) target action date for the drug. Further, the drug has also received marketing authorization in Europe in August last year.
Overall the Street has a $4.67 average price target on the stock which indicates a massive 368.12% potential upside in the stock. That’s on top of a 52% price gain the stock has seen over the past six months already.
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