Cidara Therapeutics, Inc. (NASDAQ: CDTX) watch its shares make slight gains Thursday. The 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.
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.
CDTX shares began Thursday trading up two cents, or 1.8%, to $1.12.
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