Cidara's Lower Than Expected Q4 Earnings Overshadows FDA Nod For Antifungal

 

• 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.
• 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.

https://www.benzinga.com/general/biotech/23/03/31474735/cidaras-lower-than-expected-q4-earnings-overshadows-fda-nod-for-antifungal-treatment