CDTX - Cidara stock soars 29% on FDA approval filing for rezafungin sale of US rights for drug for $30M upfront

Cidara Therapeutics ( NASDAQ: CDTX ) said it filed for U.S, approval of rezafungin to treat a type of fungal infection called invasive candidiasis and also granted Melinta Therapeutics ( OTCPK:MLNTQ ) an exclusive license to commercialize rezafungin in the U.S.

Cidara filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for rezafungin to treat candidemia and invasive candidiasis — an infection caused by a yeast (a type of fungus) called Candida which can affect the blood, heart, brain, eyes, bones, or other parts of the body, according to the CDC .

The company said it is also developing Rezafungin, a once-weekly echinocandin antifungal, to prevent invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation.

Cidara expects that the FDA will grant an action date on the NDA, if accepted, for Q1 2023.

Meanwhile, in exchange for granting Melinta exclusive commercialization rights to rezafungin in the U.S., Cidara will get $30M upfront, and is eligible to receive $60M in regulatory milestone and up to $370M in commercial milestone, plus royalties on annual net sales of rezafungin in the U.S., subject to offset for certain expenses incurred by Melinta.

Cidara said it will be responsible for completing the ongoing global Phase 3 prophylaxis study, dubbed ReSPECT, and other activities required by the FDA to get an NDA approval of rezafungin for treatment and prophylaxis uses in the U.S.

Cidara retains the rights to rezafungin in Japan, while Mundipharma retains the commercial rights to rezafungin outside the U.S. and Japan.

"This transaction eliminates the need for Cidara to build commercial infrastructure to launch rezafungin in the U.S. The upfront proceeds and additional expected near-term payments from this partnership and our current collaborations with Mundipharma and Janssen provide multiple sources of non-dilutive capital that could support the completion of the rezafungin development program and enable us to further advance our Cloudbreak DFC platform programs," said Cidara President and CEO Jeffrey Stein.

CDTX + 28.94% to $0.88 premarket July 26.

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