Cidara Therapeutics Granted FDA Breakthrough Therapy Designation For Flu-Preventing Antiviral

Cidara Therapeutics, Inc. (CDTX) on Thursday said that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its drug CD388 for the prevention of influenza A and B in adults and adolescents who are at higher risk of disease-related complications.

The new designation is in addition to the Fast Track designation granted to the drug by the agency in June 2023. CEO Jeffrey Stein said that the designations underscore the importance of the drug as a potential new non-vaccine prophylactic for seasonal influenza.

“Individuals who have chronic medical conditions, advanced age, or are immune compromised may not be adequately protected by current vaccines, leaving them at higher risk for infection and complications from flu. As a long-acting prophylactic drug, CD388’s activity does not rely on an immune response, making it a potential prevention option for high-risk individuals as well as those for whom vaccines are contraindicated,” he added.

The Breakthrough Therapy designation was awarded to the drug based on the results of a study in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64. The company is now looking toward advancing the drug through its ongoing late-stage trial.

The Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition. Benefits of the designation include eligibility for priority review and the FDA’s organizational commitment to involving senior management to guide the company on the most efficient route to approval, the company noted.

Shares of the company rose 8% at the time of writing. On Stocktwits, retail sentiment around CDTX stock jumped from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

H.C. Wainwright analyst Sara Nik subsequently raised the firm’s price target on Cidara Therapeutics to $150 from $110 while keeping a ‘Buy’ rating on the shares. The new price target implies a potential upside of over 52% from the stock’s closing price on Wednesday.

CDTX stock nearly quadrupled in value this year. 

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