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Achaogen's Plazomicin Gets Breakthrough Therapy Designation

Zacks Equity Research

Achaogen, Inc. AKAO announced that the FDA granted Breakthrough Therapy designation for plazomicin, for the treatment of serious bacterial infections due to MDR enterobacteriaceae, including carbapenem-resistant enterobacteriaceae (CRE).

Achaogen’s shares are up 100.3% year to date, comparing favorably with an increase of 7.2% witnessed by the Zacks classified Medical - Drugs industry.

The Breakthrough Therapy designation was granted based on the data from the phase III study, CARE study for plazomicin to the treatof bloodstream infections (BSI) caused by certain enterobacteriaceae in patients who have limited or no alternative treatment options. In 2012, the had FDA granted Fast Track designation for the development and regulatory review of plazomicin to treat serious and life-threatening CRE infectionsThe company plans to include the CARE trial data, along with data from the EPIC trial and submit the new drug application (NDA) for plazomicin in the second half of 2017.

Breakthrough Therapy Designation from the FDA will expedite the development and review of drugs that are intended to treat serious diseases and should provide access of the drug to patients as soon as possible.

Achaogen is a late-stage biopharmaceutical company committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. The company has other programs in early and late preclinical stages focused on other MDR gram-negative infections. All product candidates are investigational only and have not been approved for commercialization.

 

Achaogen, Inc. Price

 

Achaogen, Inc. Price | Achaogen, Inc. Quote

Zacks Rank and Key Picks

Achaogen currently holds a Zacks Rank #3 (Hold). Some other favorably placed stocks in the health care sector are VIVUS, Inc. VVUS , MEI Pharma, Inc. MEIP and Aeglea BioTherapeutics AGLE . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates have narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all the four trailing quarters, with an average beat of 233.69%.

MEI Pharma’s estimates have turned around from loss per share of 1 cent to gain of 1 cent per share for 2017 over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.

Aeglea’s loss per share estimates have narrowed from $3.64 to $2.48 for 2017 over the last 60 days. The company pulled off positive earnings surprises in three of the four trailing quarters, with an average beat of 20.75%.

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