Achaogen Rises on Late-Stage Win

By Chris Lange Updated Jan 12, 4:51PM EST · Published Dec 12, 10:35AM EST

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Achaogen Rises on Late-Stage Win — © Thinkstock

Achaogen Inc. (NASDAQ: AKAO) shares saw a huge gain on Monday after the company reported positive results from its late-stage trial. The company announced that its lead product candidate, plazomicin, met the objective of non-inferiority compared to meropenem for the U.S. Food and Drug Administration (FDA) and achieved superiority for the European Medicines Agency (EMA) primary efficacy endpoints in the Phase 3 EPIC registration trial in patients with complicated urinary tract infections and acute pyelonephritis.

Additionally, in the Phase 3 CARE trial in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE), a lower rate of mortality or serious disease-related complications was observed for plazomicin compared with colistin therapy, one of the few remaining antibiotics for treatment of infections due to CRE.

In the EPIC trial, plazomicin successfully met the objective of non-inferiority compared to meropenem for the FDA-specified primary efficacy endpoints and achieved superiority for the EMA-specified primary efficacy endpoints.

The company plans to submit a New Drug Application (NDA), which will include EPIC and CARE data, to the FDA in the second half of 2017. Achaogen also plans to submit a Marketing Authorization Application (MAA) to the EMA in 2018.

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Kenneth Hillan, M.B. Ch.B., Achaogen’s CEO, commented:

We are thrilled with the outcome of both the EPIC and CARE clinical trials and the potential opportunity for plazomicin to address many of the multi-drug resistant bacterial infections occurring every day. We are grateful to the patients and investigators who were involved in both of these studies, and we look forward to seeking plazomicin’s approval from FDA and EMA. We believe that, if approved, plazomicin will provide an important new option in treating MDR infections, including those caused by CRE.

Shares of Achaogen were last seen up over 66% at $8.72, with a consensus analyst price target of $10.25 and a 52-week trading range of $2.59 to $8.70.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.