FDA panel backs plazomicin for cUTI, but not blood infections

Achaogen Inc. (NASDAQ:AKAO) slid $4.35 (30%) to $10.35 in after-hours trading Wednesday after an FDA panel split on the indications being considered for plazomicin (formerly ACHN-490). FDA’s Antimicrobial Drugs Advisory Committee voted 15-0 in favor of approving the plazomicin to treat complicated urinary tract infections (cUTIs) and 11-4 against the candidate's approval to treat bloodstream infections.

The next-generation aminoglycoside antibiotic is under FDA Priority Review for both indications with a June 25 PDUFA date...