CDTX - Cidara stock dips amid FDA approval of antifungal drug Rezzayo

2023-03-23 04:49:08 ET

The U.S. Food and Drug Administration (FDA) approved Cidara Therapeutics ( NASDAQ: CDTX ) and Melinta Therapeutics' Rezzayo (rezafungin for injection) to treat candidemia and invasive candidiasis in adults with limited or no alternative treatment options.

Cidara said Rezzayo — a once-weekly next-generation echinocandin — is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

Invasive candidiasis is 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. Candidemia is the most common form of invasive candidiasis, according to the CDC .

"We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer," said Melinta President and CEO Christine Miller.

Cidara had filed for U.S approval of rezafungin in July 2022 and had granted Melinta a license to commercialize rezafungin in the U.S. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to  Mundipharma in all other geographies.

The approval was backed by data from a global phase 3 trial called ReSTORE, a phase 2 study, dubbed STRIVE, and non-clinical development program.

Rezafungin is also under review in the EU.

The company's stock has been gaining earlier in the week ahead of the FDA decision.

Meanwhile, a deadly fungal Candida auris, a type of yeast, which was first detected about 15 years ago in Japan, has made a comeback in the U.S.. The fungus is often multidrug-resistant, as per the CDC .

CDTX -7.89% to $1.75 premarket March 23

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