SAN DIEGO, June 22, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CD388, Cidara’s novel drug-Fc conjugate (DFC) candidate. CD388 is being developed in collaboration with Janssen Pharmaceuticals for the prevention of influenza A and B infection in adults who are at high risk of severe influenza, including those for whom vaccines are either ineffective or contraindicated.
Fast Track designation aims to facilitate the development and expedite the review of drugs to treat serious conditions with unmet medical needs. The purpose is to get important new drugs to patients earlier. Companies that are granted this designation are given the opportunity for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Priority Review.
“We are pleased that the FDA has granted Fast Track designation for CD388, which emphasizes the unmet need for effective new prevention options for the many individuals who are not adequately protected by available influenza vaccines,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Based on its compelling profile and the promising data generated to date, we believe CD388 has the potential to serve as a safe and effective option for these high-risk patient populations with limited options for protection against both seasonal and pandemic strains of influenza A and B.”
Cidara recently announced promising interim efficacy and safety data from the ongoing Phase 2a study, being conducted in collaboration with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, that is evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain.
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including drug-Fc conjugates (DFCs) from its proprietary Cloudbreak® platform targeting oncologic and viral diseases. In addition, Cidara recently received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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 safe harbor provisions of 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,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether the ongoing Phase 2a study of CD388 will produce data consistent with the interim analysis, whether Cidara or Janssen will conduct the additional studies required to complete clinical development of CD388, and whether additional studies will ultimately generate the data necessary to demonstrate the safety and efficacy of CD388. Such 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 unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any 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.