Alkermes Public Limited Company (NASDAQ : ALKS)
Alkermes Public Limited Company (ALKS), an integrated biopharmaceutical company yesterday announced that two late stage studies for ALKS 5461 which is used for the treatment of depression didn’t meet their primary endpoints. The study showed that ALKS 5461 did not show statistically significant improvement versus the placebo.
Alkermes Public Limited Company CEO’s Comments
“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,” said Richard Pops, Chief Executive Officer of Alkermes. “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.” Business Wire
Comments from Chief Medical Officer
“We are gaining important insights as we proceed with the FORWARD program for ALKS 5461. The third pivotal efficacy study, FORWARD-5, is ongoing and we plan to adapt it to incorporate findings from FORWARD-3 and FORWARD-4,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Clinical trials of new medicines for the treatment of major depressive disorder are complicated by significant placebo response. We designed the FORWARD pivotal program to include three efficacy studies as we recognize that this is a challenging disease state where multiple clinical studies and expansive analyses are generally necessary to confirm the efficacy of a new medicine.” Business Wire
ALKS Technical Analysis
ALKS gapped down in price yesterday to $39.28, down from the prior day’s close of $60.42, which is a 35% decrease in price. Taking a look at the daily chart, we can see the last time ALKS traded below this price level we have to go all the way back to December 16th 2013 when it traded at $38.26. ALKS has a float of 148.88 million shares and is trading over 12 times the normal daily trading volume. ALKS did reach pre market lows of $39.12, but bounced back $0.16 at the open. For trading purposes, my entry point short would have been $39.20 looking for a run down to $38. My stop loss would have been $39.40, fearing anything above that and the stock would start to fill in the gap down.
Company Profile
Alkermes Public Limited Company, an integrated biopharmaceutical company, engages in the research, development, and commercialization of pharmaceutical products to address unmet medical needs of patients in various therapeutic areas. The company offers RISPERDAL CONSTA for the treatment of schizophrenia and bipolar I disorder; INVEGA SUSTENNA to treat schizophrenia schizoaffective disorder; AMPYRA/FAMPYRA to treat multiple sclerosis; BYDUREON to treat type II diabetes; and VIVITROL for alcohol and opioid dependence. It is also developing Aripiprazole Lauroxil for the treatment of schizophrenia; ALKS 5461 that is under Phase III study for the treatment of depressive disorder; ALKS 3831, a Phase II study medicine to treat schizophrenia; ALKS 8700, a monomethyl fumarate molecule, which is under Phase I study to treat multiple sclerosis; ALKS 7106, a drug candidate to treat pain with intrinsically low potential for abuse and overdose death; and RDB 1419, a proprietary investigational biologic cancer immunotherapy product that is under pre-clinical stage. The company serves pharmaceutical wholesalers, specialty pharmacies, and specialty distributors directly through its sales force. It has collaboration agreements with Janssen Pharmaceutica, NV; AstraZeneca plc; Acorda Therapeutics, Inc.; and other collaboration partners. Alkermes Public Limited Company was founded in 1987 and is headquartered in Dublin, Ireland. Yahoo Finance
