AKAO just tanked 16%.
Achaogen (AKAO), a biopharmaceutical company, said Tuesday the U.S. Food and Drug Administration (FDA) has approved ZEMDRI (plazomicin) for adults with complicated urinary tract infections, including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.
However, AKAO shares were down 10% after resuming trade after the company said it received a complete response letter (CRL) saying its study does not provide substantial evidence of effectiveness of plazomicin to treat bloodstream infection.
The company said it intends to meet with the FDA to determine whether there is a feasible resolution to address the CRL.
Where does it go from here? Surely investors will be back into it seeing that it got approval for one drug.
Update 19%. Holy cow
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