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     237  0 Kommentare Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1) - Seite 3

    Cidara is also currently conducting a second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

    Rezafungin was first approved for the treatment of candidemia and invasive candidiasis in individuals with limited or no alternative treatment options by the FDA in March 2023.12  

    About Cidara Therapeutics

    Cidara is using its proprietary Cloudbreak platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO (rezafungin for injection), which it has licensed to multiple partners to commercialise in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    About Mundipharma

    Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

    Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer healthcare as well as other severe and debilitating disease areas. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.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 safe harbour 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,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin; whether it will be approved for marketing in the EU; and the likelihood that rezafungin, if approved in the EU, will be prescribed by physicians or approved for reimbursement. 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. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q 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.

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    Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1) - Seite 3 The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.2,3If approved by the European Medicines Agency, …