FDA Ad Com backs approval of rezafungin

The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee has voted favorably, by 14 to 1, that Cidara Therapeutics (Nasdaq: CDTX), as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options.

The drug is 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.

Cidara’s shares leapt 24% to $1.15 in pre-market trading following the announcement, though they drifted back to $1.00 for an 8% rise by mid-morning.