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Read Why HC Wainwright Lowered Price Target On This Small Biotech Stock

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·2 min read
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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.

  • Related: Cidara Therapeutics Stock Slides Despite Acing Rezafungin Trial In Fungal Infection.

  • 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.

Latest Ratings for CDTX

Sep 2021

Aegis Capital

Maintains

Buy

Sep 2021

WBB Securities

Upgrades

Buy

Strong Buy

Mar 2021

Aegis Capital

Initiates Coverage On

Buy

View More Analyst Ratings for CDTX

View the Latest Analyst Ratings

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