Cidara Therapeutics receives U.S. FDA fast track designation for CD388

Cidara Therapeutics (CDTX) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation, FTD, to CD388, Cidara’s novel drug-Fc conjugate, DFC, candidate. CD388 is being developed in collaboration with Janssen Pharmaceuticals (JNJ) 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. “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.”