The leading pipeline drug being developed by Cidara Therapeutics (CDTX 12.44%) got a real boost from a regulator on Thursday, and the biotech's share price moved accordingly. Cidara's stock closed the day more than 12% higher, during a session in which the bellwether S&P 500 (^GSPC -0.28%) dropped by 0.3%.
Reporting a breakthrough
Cidara announced before market open that the U.S. Food and Drug Administration (FDA) has granted the healthcare company's investigational flu drug its Breakthrough Therapy designation. With that tag, the FDA is set to accelerate the approval decision process for the medication.
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The drug, designated CD388 by Cidara, is a non-vaccine treatment aimed at preventing seasonal flu. It targets people who want or need to have some protection from the highly common affliction, but are medically unable (or simply unwilling) to be administered a traditional vaccine.
Previously, CD388 was granted the U.S. regulator's fast-track designation for review. This, combined with the Breakthrough Therapy tag, means a decision is more likely to be handed down in the very near future.
Far advanced in the pipeline
In its press release trumpeting the news, Cidara quoted CEO Jeffrey Stein as saying that the FDA's move "underscores the importance of CD388 as a potential new non-vaccine prophylactic for seasonal influenza."
The drug is currently in phase 3 clinical testing, the company added.
