ACHAOGEN, INC. (NASDAQ:AKAO) Files An 8-K Other EventsItem 8.01
On May 23, 2017, Achaogen, Inc. announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for plazomicin for the treatment of bloodstream infections caused by certain Enterobacteriaceae, Klebsiella pneumoniae and Enterobacter aerogenes. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies. Breakthrough Therapy designation is a process designed to expedite the development and review of designated drugs. Should the clinical development program not continue to meet the criteria for Breakthrough Therapy designation, however, the designation may be rescinded.
About ACHAOGEN, INC. (NASDAQ:AKAO)
Achaogen, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in the discovery, development and commercialization of antibacterials to treat multi-drug resistant (MDR) gram-negative infections. The Company is developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant enterobacteriaceae (CRE). Plazomicin is an aminoglycoside designed to overcome clinically relevant aminoglycoside resistance mechanisms. In addition, its research and development pipeline includes two programs that specifically target Pseudomonas aeruginosa or Acinetobacter baumannii infections: a program to discover and develop small molecule inhibitors of LpxC, which is an enzyme essential for the synthesis of the outer membrane of gram-negative bacteria, and a therapeutic antibody program. Its development plan for plazomicin includes over two Phase III clinical trials. ACHAOGEN, INC. (NASDAQ:AKAO) Recent Trading Information
ACHAOGEN, INC. (NASDAQ:AKAO) closed its last trading session up +0.90 at 26.08 with 357,394 shares trading hands.