- 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.
- Also Read: Johnson & Johnson-Backed Antiviral Candidate Effectively Prevents Influenza Infection.
- 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.
© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
