Rezzayo approved by FDA amid rapid Candida auris spread

23 March 2023

Cidara Therapeutics (Nasdaq: CDTX) saw its shares fall 10% to $1.71 in after-hours trading yesterday, despite receiving a regulatory approval for a new drug.

The company revealed that the US Food and Drug Administration (FDA) approved Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.

The drug was licensed to Melinta Therapeutics for the US market, for a $30 million upfront payment to Cidara and a further $460 million, including $60 million in regulatory milestones and up to $370 million in commercial milestones, plus tiered royalties on yearly sales.

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