Alkermes (ALKS) Shares Pounded after Depression Drug Fails Studies

Shares of Alkermes plc (ALKS) were off -19.92 or -32.97 percent in Thursday’s premarket after the company announced the topline results of two phase 3 studies of the company’s drug for treatment of depression . Alkermes stock closed at $60.42 per share, up +0.89 or +1.50 percent in Wednesday’s regular trading session.



Dublin, Ireland based Alkermes plc is a biopharmaceutical company formed after the 2011 merger of Alkermes Inc. and Elan Drug Technologies, the drug manufacturing division of Elan Corporation plc.
The company has research facilities in Waltham, Massachusetts with manufacturing plants in Gainesville, Georgia, Wilmington, Ohio and Athlone, Ireland. The company’s focus is on the development of drugs and drug candidates that treat serious illnesses such as chronic depression, diabetes, bipolar disorder, schizophrenia and addiction. Its main pipeline product, ALKS-5461 is a K-opioid receptor antagonist next generation antidepressant.

This morning’s announcement of the topline results of two Phase 3 FORWARD-3 and FORWARD-4, Studies for the company’s ALKS-5461 treatment of Major Depressive Disorder showed the drug had failed to hit the primary endpoints. The failure of the two studies is a significant setback in the field of depression drug research.

The company cited a higher placebo response as the main reason for the failure of the two studies. Nevertheless, despite the protocol of pharmaceutical companies setting up three Phase 3 studies, with the goal of succeeding in two of them, Alkermes refuses to give up. The company said there was a statistical significance in a post hoc analysis in a FORWARD-4 study which showed that the entire group in a 2mg/2mg dose group had achieved the primary end point on their Montgomery Asburg Depression Rating Scale of MADRS scores.

Chief Executive Officer of Alkermes, Richard Pops said in the company’s press release that, “We are steadfast in our commitment to developing new medicines for serious CNS conditions where there is a clear and compelling need for new treatment options for patients and their families. Major depressive disorder is one of these conditions. We are building a large body of evidence supporting our belief in the clinical utility and the novel mechanism of action of ALKS 5461. We await the results of FORWARD-5 and will determine our next steps along the regulatory path with those results in hand.”

Alkermes is now adjusting its remaining Phase 3 study by adding new patients and rearranging its statistical analysis plan. The company is hoping for success in its FORWARD-5 study to combine with the FORWARD-4 results in order to present the post hoc analysis to the U.S. Food and Drug Administration for approval of the drug.

Despite the optimism of the company’s Chief Executive, Alkermes must still get the FDA’s approval even if subsequent FORWARD-4 and 5 studies show positive results. Investors are showing their disappointment in this morning’s premarket, taking the stock down almost -35 percent. The stock has not seen these levels since September of 2014, and will be trading at a new 12 -month low when it opens for trading later this morning.

Other News About ALKS

Alkermes Plc breached its 50 day moving average in a Bearish Manner : January 8, 2016

Capital Cube’s technical analysis showed the stock was under distribution earlier this month.

Alkermes Upgraded to Hold on Encouraging Portfolio Update

Zacks upgraded the stock after the company initiated pivotal programs for its treatments of schizophrenia and multiple sclerosis.
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Published on Jan 21, 2016
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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