Alkermes Falls Most Since 2002 as Depression Drug Trials Failby
Alkermes Plc lost more than a third of its market value after the company said that its drug for depression, its most advanced product in development, failed in two final-stage tests.
The company is testing the ALKS 5461 in three clinical trials as a treatment for major depressive disorder, used with other therapies, and reported results from two of the trials on Thursday. In both trials, the drug failed to meet its primary goal of improving patients’ depression when compared to a placebo, the company said in a statement.
Alkermes shares fell 36 percent to $38.48 at 10:12 a.m. in New York, the biggest intraday decline since 2002. The stock has lost almost half its value in the past month, including today’s drop.
The treatment is meant to increase the effectiveness of standard depression pills for patients whose responses to those drugs are not good enough. A third trial is ongoing, and Alkermes said that it plans to expand that test by adding more patients. If it’s successful, the company will meet with U.S. Food and Drug Administration about a way forward for the medicine.
The first trial, called FORWARD-3, looked at 429 patients who hadn’t responded sufficiently to standard depression treatments. “No treatment effect of ALKS 5461 was observed,” the company said in the statement. In FORWARD-4, which examined 385 patients on one of two doses of the drug, or a placebo, the company said that while the patients getting ALKS 5461 showed some improvement, the trial didn’t meet its goal.
Alkermes said it will announce more details of the third trial, including when it will be completed, by the end of March.