ALKS 5461 proved effective in re-balancing brain function in patients with major depressive disorder that failed to benefit from other treatments, the company reported late Thursday. Alkermes will now meet with the Food and Drug Administration to determine the next steps toward regulatory approval.
According to the National Institute of Mental Health, depression is one of the most common mental disorders in the U.S., with an estimated 16 million adults reporting at least one major depressive episode in the past year.
The news followed earlier setbacks with drug. In January, Alkermes shares plummeted after ALKS 5461 failed to meet goals in an earlier Phase III trial.
Even with Friday’s big gains, the company’s shares remain far below the stock’s 52-week high of $80.71. Alkermes shares ended the day at $55.62, gaining $12.11 during the session.