Biotech Stocks Facing FDA Decision In June


The FDA decision on Alkermes plc’s (ALKS) supplemental New Drug Application for two-month dosing option of ARISTADA for the treatment of schizophrenia is scheduled for June 5, 2017.

ARISTADA, an injectable drug with once-monthly and once-every-six-weeks dosing options, was approved by the FDA to treat adults with schizophrenia in October 2015.

If approved, the new two-month offering would expand the range of ARISTADA dosing intervals to include a third option for patients with schizophrenia.

The annual net sales of ARISTADA were $47.2 million in 2016 compared to $4.59 million in 2015.

About 3.5 million people in the U.S. and roughly 24 million people worldwide are affected by schizophrenia, according to reports.

ALKS closed yesterday’s (May 24) trading at $58.25, up 0.94%.