Achaogen Inc AKAO shares are tumbling Thursday after a mixed FDA panel vote on Plazomicin, its lead candidate to treat serious bacterial infections due to multidrug-resistant enterobacteriaceae.
Achaogen shares were slumping 25.3 percent to $10.98 at the time of publication.
What Happened
The FDA's Antimicrobial Drugs Advisory Committee voted 11-4 that the company failed to provide substantial evidence of safety and effectiveness of its plazomicin to treat bloodstream infections in patients with limited or no treatment options.
The panel voted 15-0 in favor of safety and effectiveness for treating complicated urinary tract infections.
Why It's Important
Plazomicin is being evaluated in two Phase 3 trials: the EPIC registration trial and CARE descriptive trial. The EPIC trial is evaluating the pipeline candidate for complicated UTIs, and is a single pivotal trial supporting a New Drug Application in the U.S. and Marketing Authorization Application, or MAA, in Europe.
The CARE trial is testing patients with serious bacterial infections.
The company submitted a NDA in October for Plazomicin for treating complicated UTIs; the FDA accepted the application in December.
When the FDA reviews a NDA, it considers the discussions, voting pattern and recommendations of the panel. Yet the agency is not bound to go with the panel decision.
SunTrust Robinson Humphrey analyst Edward Nash said he's optimistic for off-label usage of plazomicin for bloodstream infections, even if the indication is not present on the label.
"We believe with the options for this patient group being highly limited, along with the robust data demonstrated from the CARE study, physicians will prescribe plazomicin based on data, not label," the analyst said.
Nash maintained a Buy rating on Achaogen with a price target lowered from $27 to $16 on the basis of lower estimated market penetration rates for bloodstream infection treatment.
What's Next
Plazomicin's PDUFA action date is set for June 25. If the FDA approves the drug by the target date, Achaogen said it would launch in the U.S. soon after.
Related Links:
Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates
Photo by the Centers for Disease Control and Prevention via Wikimedia.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
