FDA Grants Cidara Therapeutics' CD388 Breakthrough Therapy Designation for Flu Prevention in High-Risk Patients

Cidara Therapeutics Inc. (NASDAQ:CDTX) is one of the best hot stocks to invest in. On October 9, Cidara Therapeutics announced that the US FDA granted Breakthrough Therapy designation for its drug-Fc conjugate/DFC therapeutic candidate, CD388. The designation is for the prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications.

The high-risk group includes individuals with underlying immunodeficiency, those at higher risk of severe influenza despite vaccination, or those for whom vaccines are contraindicated. The Breakthrough Therapy designation was supported by positive results from the Phase 2b NAVIGATE trial, which demonstrated statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64.

Top-line data from the NAVIGATE study were initially announced in June this year, with additional data expected to be presented at scientific conferences later in October. CD388 is developed using Cidara’s proprietary Cloudbreak platform, which is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. Cidara plans to submit a Biologic License Application/BLA for CD388.

Cidara Therapeutics Inc. (NASDAQ:CDTX) is a biotechnology company that develops targeted therapies for patients facing cancers and other serious diseases.

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Disclosure: None. This article is originally published at Insider Monkey.