Achaogen Inc. (NASDAQ: AKAO) shares were crumbling on Tuesday following some mixed news from the U.S. Food and Drug Administration (FDA). Essentially the agency issued an approval for Zemdri (plazomicin) for the treatment of urinary tract infections, but also a Complete Response Letter (CRL) for plazomicin for the treatment of bloodstream infection.
As for the approval, the FDA approved Zemdri for adults with urinary tract infections, including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.
In regards to the potential indication for plazomicin for the treatment of bloodstream infection, the FDA issued a CRL stating that the CARE study does not provide substantial evidence of effectiveness of plazomicin for the treatment of bloodstream infection. Achaogen intends to meet with the FDA to determine whether there is a feasible resolution to address the CRL.
Blake Wise, Achaogen’s CEO, commented:
The approval of ZEMDRI marks a significant milestone for Achaogen and we are excited to offer healthcare practitioners a new treatment option for patients with certain serious bacterial infections. ZEMDRI is designed to retain its potent activity in the face of certain difficult-to-treat multidrug resistant infections, including CRE and ESBL- producing Enterobacteriaceae. Today’s milestone was made possible by our employees, by patients and investigators involved in our clinical trials, and by BARDA, who contributed significant funding for the development of ZEMDRI. This marks an important step in our commitment to fighting multidrug resistant bacteria and we are excited to launch ZEMDRI, a much needed once-daily antibiotic.
Excluding Tuesday’s move, Achaogen had underperformed the broad markets, with its stock down about 46% in the past 52 weeks. In 2018 alone, the stock was actually up about 12%.
Shares of Achaogen were last seen down more than 25% at $8.92, with a consensus analyst price target of $18.20 and a 52-week range of $9.53 to $25.22.