Alkermes plc | $ALKS Stock | Shares Climb Up On Positive Phase 3 Study Results Of ALKS 5461


Alkermes plc (NASDAQ: ALKS)



Alkermes plc (ALKS), a biopharmaceutical company yesterday announced positive topline results from its phase 3 study of ALKS 5461 for major depressive disorder (MDD). The study met its primary endpoint and showed statistically significant reduced symptoms of depression in patients with MDD compared to the placebo.


Alkermes plc CMO and CEO’s Comments

“We designed ALKS 5461 to have a novel mechanism of action for the treatment of MDD, a serious disease where new therapeutic options are highly sought after as millions of patients in the U.S. do not respond to standard courses of antidepressant therapy,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “With the successful completion of the FORWARD-5 study and data from more than 1,500 patients to date, we have established a strong foundation of evidence of ALKS 5461’s clinical utility in the adjunctive treatment of major depressive disorder. With these data now in hand, we will move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461, with a goal of bringing this important new medication to patients with MDD.”

“ALKS 5461 embodies our dedication to developing novel and safe CNS medicines that address compelling unmet needs faced by large numbers of patients,” said Richard Pops, Chief Executive Officer of Alkermes. “Major depressive disorder affects millions of people and their families, and represents one of the greatest burdens of suffering and cost of any disease today. New drug development in the field is challenging and we are excited to advance ALKS 5461 in this important indication.”  Business Wire


ALKS Technical Analysis


ALKS opened trading yesterday at $43.01 which was up from the previous day’s trading close of $42.86. ALKS closed trading yesterday at $43.51 and spiked up after market to $62, equivalent to a 43% increase from the closing price. Taking a look at the daily chart we can see the last time ALKS traded below these levels we have to go back to January 15th when it traded at $62.36. Taking a closer look at the daily chart we can see that before the spike up ALKS had been in an overall downward trend dating back to September 22nd when it traded at $51. ALKS has a float of 128.58 million shares and traded below the normal daily trading volume on Thursday. For trading purposes, I would like to see ALKS open trading on Friday above $56 and if it does I would be looking to take a long position at the bell. My stop loss would be $1.00 from my entry position fearing anything more than that and the stock would start to fill in the gap up.


Company Profile

Alkermes plc, a biopharmaceutical company, researches, develops, and commercializes pharmaceutical products that are designed to address unmet medical needs of patients in various therapeutic areas worldwide. The company’s marketed products include ARISTADA (aripiprazole lauroxil) for the treatment of schizophrenia; VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of alcohol and opioid dependence; INVEGA SUSTENNA for the treatment of schizophrenia and schizoaffective disorder; INVEGA TRINZA for the treatment of schizophrenia used in people who have been treated with INVEGA SUSTENNA; RISPERDAL CONSTA for the treatment of schizophrenia and bipolar I disorder; AMPYRA (dalfampridine)/FAMPYRA (fampridine) to improve walking in adults with multiple sclerosis who have walking disability; and BYDUREON (exenatide extended-release for injectable suspension) for the treatment of type 2 diabetes. It is also developing ALKS 5461 that is in a Phase III study for the treatment of major depressive disorder; ALKS 3831, which is in a Phase II study to treat schizophrenia; ALKS 8700, a monomethyl fumarate molecule, which is in a Phase I study to treat multiple sclerosis; ALKS 6428, which is in a phase III study to help physicians transition patients from physical dependence on opioids to antagonist therapy; Aripiprazole lauroxil, an injectable atypical antipsychotic, which has completed a Phase I study for the treatment of schizophrenia; ALKS 7119 that is in a Phase I study for the treatment of various central nervous system diseases; RDB 1450, a proprietary investigational biologic cancer immunotherapy product that is in pre-clinical stage. The company serves pharmaceutical wholesalers, and specialty pharmacies and distributors. It has collaboration agreements with Janssen Pharmaceutica N.V.; AstraZeneca plc; and Acorda Therapeutics, Inc. Alkermes Public Limited Company was founded in 1987 and is headquartered in Dublin, Ireland.  Yahoo Finance