Market Overview

Why Achaogen Shares Are Getting Crushed On Plazomicin FDA News

Share:
Why Achaogen Shares Are Getting Crushed On Plazomicin FDA News
Related AKAO
31 Stocks Moving In Monday's Pre-Market Session
The Daily Biotech Pulse: FDA Nod For Roche, Bristol-Myers Hikes Dividend, 2 Biotechs To Debut

Achaogen Inc (NASDAQ: 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:

Benzinga's Daily Biotech Pulse: Achaogen Slumps On Mixed FDA Panel Vote, Pacific Biosciences Sinks On Q1 Miss

Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates

Photo by the Centers for Disease Control and Prevention via Wikimedia. 

Latest Ratings for AKAO

DateFirmActionFromTo
Nov 2018SunTrust Robinson HumphreyDowngradesBuyHold
Nov 2018H.C. WainwrightDowngradesBuyNeutral
Nov 2018WedbushDowngradesOutperformNeutral

View More Analyst Ratings for AKAO
View the Latest Analyst Ratings

Posted-In: Analyst Color Biotech News Price Target Reiteration FDA Top Stories Analyst Ratings Best of Benzinga

 

Related Articles (AKAO)

View Comments and Join the Discussion!

Latest Ratings

StockFirmActionPT
SHWKeyBancMaintains450.0
ACNCitigroupUpgrades169.0
CGBDJP MorganUpgrades15.5
NLYJP MorganUpgrades10.5
NTNXMorgan StanleyUpgrades58.0
View the Latest Analytics Ratings
Don't Miss Out!
Join Our Newsletter
Subscribe to:
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
Your weekly roundup of hot topics in the exciting world of fintech.
Thank You
for registering for Benzinga’s newsletters and alerts.
• The Daily Analysts Ratings email will be received daily between 7am and 10am.
• The Market in 5 Minutes email will be received daily between 7am and 8am.
• The Fintech Focus email will be received every Friday between 2pm and 5pm.

Analysts Defend Esperion As Shares Sell Off Sharply

Wayfair's Better-Than-Expected Q1 Turns BofA Bullish