US Biotech's Anti-Fungal Wins European Approvals
Research Report

Cidara Therapeutics Inc. (CDTX:NASDAQ) has secured European Commission (EC) approval for its lead anti-fungal candidate Rezafungin to treat invasive candidiasis infections in adults, according to H.C. Wainwright analyst Ed Arce in a December 22 research note. With this regulatory green light, Cidara stands to receive a US$11.1 million milestone payment from commercialization partner Mundipharma.

Arce had anticipated approval following Rezafungin receiving a positive opinion in October 2023 from the Committee for Medicinal Products for Human Use (CHMP), which serves as the European Medicines Agency's (EMA) expert scientific committee. Rezafungin's approval was supported by data from the global pivotal ReSTORE Phase 3 trial demonstrating non-inferiority versus the standard of care.

In addition to Europe, Arce sees China as another major commercial opportunity for Rezafungin. 

"As another major market for REZZAYO, we look for top-line data from the Phase 3 ReSTORE study's Chinese segment in 2Q24 to support its potential approval in China. Affirm Buy," Arce wrote. 

Reflecting confidence Rezafungin can achieve global success, Arce rated Cidara shares a Buy with a US$6 price target. This implies over 700% upside from the current US$0.74 share price.

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Disclosures for H.C. Wainwright & Co., Cidara Therapeutics Inc., December 22, 2023

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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Cidara Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of November 30, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Cidara Therapeutics, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Cidara Therapeutics, Inc. for non-investment banking services in the previous 12 months.

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