Cidara Therapeutics Announces FDA Acceptance of Priority Review of New Drug Application for … | New

SAN DIEGO, Sept. 20, 2022 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing diseases, today announced that the U.S. Food and Drug Administration (FDA) has agreed to file and granted priority review of its New Drug Application (NDA) for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned March 22, 2023 as a Target Action Date for the Prescription Drug User Fee Act (PDUFA) made possible by the designation of rezafungin as a Qualified Infectious Disease Product (QIDP) and has indicated that it expects currently holding an advisory committee meeting to discuss the application. The designation QIDP is reserved for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. Rezafungin is a new weekly echinocandin antifungal in development for the treatment of candidemia and invasive candidiasis, and for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and bone marrow transplantation.

“Today’s announcement is an important step forward for patients battling hard-to-treat and often fatal invasive candidemia and candidiasis, and represents a critical milestone for Cidara’s rezafungin development program,” said said Jeff Stein, president and CEO of Cidara Therapeutics. “The data generated from our Phase 2 and Phase 3 trials demonstrated that rezafungin could transform the current standard of care for the treatment of invasive infections. candidiasis infections, and we are excited that rezafungin could potentially be the first new drug approved for this indication in over a decade.

The NDA submission for rezafungin was supported by positive clinical data from the global Phase 3 ReSTORE and Phase 2 STRIVE clinical trials. Rezafungin given once weekly demonstrated statistical non-inferiority to caspofungin, the current standard of care, given once daily, meeting key FDA and European Medicines Agency endpoints (EMA).

Cidara retains rights to rezafungin in Japan and has licensed commercial rights to Melinta Therapeutics in the United States and Mundipharma Medical in all other geographies.

About Rezafungin

Rezafungin is a new weekly echinocandin developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to enhance a clinically validated mechanism intended to enhance its efficacy and potential safety for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial with rezafungin for disease prevention fungal infections in patients undergoing allogeneic blood and bone marrow transplantation (ReSPECT trial). Rezafungin has been designated QIDP with Fast Track status by the FDA and received orphan drug designation for its use in the treatment of invasive candidiasis in the US and EU.

About Cidara Therapeutics

Cidara develops long-acting therapies designed to improve the quality of care for patients facing serious illnesses. The Company’s portfolio includes novel approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral diseases and oncology from Cidara’s exclusive Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-looking statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the provisions of exemption from the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results or strategies and are generally preceded by words such as “anticipates”, “expects”, “may”, “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements relating to our expectations as to whether the FDA will complete its review of the rezafungin NDA by the PDUFA’s target action date; whether the FDA will approve rezafungin for commercial sale in the United States and whether, if approved, rezafungin will transform the current standard of care for the treatment of invasive fungal infections. These statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements, such as unforeseen delays or negative results of preclinical or clinical trials. of Cidara. , delays in action by regulatory authorities due to inspection limitations and other effects related to COVID-19, and the impacts of the COVID-19 pandemic or other impediments on patient recruitment or other aspects of the development of rezafungin. These and other risks are identified under the heading “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date they are made and are based on management’s assumptions and estimates as of that date. Cidara undertakes no obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

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