The FDA approved Cidara Therapeutics Inc’s (NASDAQ: CDTX) antifungal Rezzayo (rezafungin) under priority review for treating candidemia and invasive candidiasis in adults with limited or no alternative treatment options, the company announced Wednesday.
While the EMA accepted the marketing authorization application for rezafungin in August 2022, it is still under review for potential approval in Europe.
Last year, Melinta Therapeutics acquired the rights to commercialize Rezzayo in the U.S.
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Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies.
The FDA approval was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program.
In clinical studies, Rezzayo demonstrated statistical non-inferiority versus caspofungin, a current once-daily standard of care.
This approval enables Cidara to receive a $20.0 million regulatory milestone payment under the terms of our agreement with Melinta Therapeutics,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
The company reported a Q4 EPS loss of $(0.19) and revenues of $10.22 million, below the consensus of $(0.17) and $10.57 million, respectively.
Price Action: CDTX shares are down 15.8% at $1.60 during the market session on the last check Thursday.
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This article Cidara’s Lower Than Expected Q4 Earnings Overshadows FDA Nod For Antifungal Treatment originally appeared on Benzinga.com
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Source: https://finance.yahoo.com/news/cidaras-lower-expected-q4-earnings-163533964.html