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U.S. marketing application filing for Cidara Therapeutics Inc's (NASDAQ: CDTX) rezafungin remains on track for mid-2022, setting up a potential early 2023 approval and launch.
Cidara confirmed that the application filing of lead antifungal drug rezafungin as a potential first-line treatment for candidemia and invasive candidiasis remains on track for mid-2022, which HC Wainwright takes to mean as late as August.
HC Wainwright lowered the price target to $6 from $7.50, citing the challenging capital market environment.
The analyst anticipates Cidara to be granted Priority Review (8 months from submission) by the FDA, which would place a potential PDUFA date in March or April 2023, followed by the commercial launch almost immediately after that if approved.
Cidara's lead influenza drug-FC conjugate, CD388, continues to progress through a Phase 1 study, advancing to the next mid-dose cohort after completing dosing in the first, low-dose cohort, in March.
At the April ECCMID meeting, CDTX presented additional results from the Phase 3 ReSTORE trial. A DDI analysis showed no dose adjustment is needed with the commonly used anticancer drugs venetoclax or ibrutinib, Needham wrote.
The analysts reiterated the Buy rating, with the price target of $6.
Exploratory analysis of ReSTORE showed a faster time to first negative blood culture for rezafungin.
CDTX, which is developing CD388 as a potent and universal therapy against Flu A & B, will lead clinical development through Phase 2 (funded by JNJ), after which Johnson & Johnson (NYSE: JNJ) will assume all further development.
Price Action: CDTX shares are down 22.6% at $0.46 during the market session on the last check Thursday.
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