Cidara wins FDA “Breakthrough” status for CD388

San Diego, USA-based biotech Cidara Therapeutics (Nasdaq: CDTX) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.

The news lifted Cidara’s shares almost 9% to $107.12 by mid-morning. This regulatory milestone follows the previously awarded Fast Track designation for the drug candidate, which is designed as a long-acting prophylactic that does not rely on an immune response for efficacy.

“This Breakthrough Therapy designation, in addition to the previously awarded Fast Track designation, underscores the importance of CD388 as a potential new non-vaccine prophylactic for seasonal influenza,” said Jeffrey Stein, president and chief executive of Cidara.