resultaten. zojuist speculatief plukje aangekocht, . lijkt me wat overdreven deze 25% afstraffing . op de plank
Cidara Therapeutics, Mundipharma Say Fungal Infections Treatment Met Primary Goals in Late-Stage Trial
BY MT Newswires
— 8:02 AM ET 12/14/2021
08:02 AM EST, 12/14/2021 (MT Newswires) -- Cidara Therapeutics ( CDTX
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) and Mundipharma said Tuesday a phase 3 trial of rezafungin met its primary endpoints as a treatment for fungal infections versus standard of care, paving the way for global regulatory filings in mid-2022.
Rezafungin met the primary endpoint for the U.S. Food and Drug Administration New Drug Application submission of all-cause mortality at day 30, and also met the primary endpoint for the European Medicines Agency Marketing Authorization Application submission of global cure at day 14.
Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, the current standard of care.
Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.
"With the results of both the STRIVE and ReSTORE trials now in hand, which together form our registration package, we intend to file our NDA with the FDA and other regulators outside the US, in mid-2022," said a principal investigator in the ReSTORE trial, George Thompson.
Cidara Therapeutics ( CDTX
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) and Mundipharma are co-developing rezafungin under a partnership agreement.
Cidara shares were down nearly 4%.
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