Key Developments: Alkermes Plc (ALKS.O)

ALKS.O on Nasdaq

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19 Aug 2014
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Latest Key Developments (Source: Significant Developments)

Alkermes PLC reaffirms FY 2014 revenue guidance; lowers FY 2014 earnings guidance
Thursday, 31 Jul 2014 07:00am EDT 

Alkermes PLC:Continues to expect total revenues to range from $580 mln to $610 mln for FY 2014.Expects FY 2014 GAAP net loss to range from $90 mln to $110 mln, or a basic and diluted loss per share of about $0.62 to $0.76.Says this compares to previous expectations of a GAAP net loss in range of $70 mln to $90 mln, or basic and diluted loss per share of about $0.48 to $0.61.Expects FY 2014 non-GAAP net income to range from $30 mln to $50 mln, and non-GAAP diluted EPS to range from $0.19 to $0.32.Says this compares to previous expectations of non-GAAP net income in range of $65 mln to $85 mln and non-GAAP diluted EPS in range of $0.41 to $0.54.FY 2014 revenue of $593 mln, net income of $74 mln and EPS of $0.49 - Thomson Reuters I/B/E/S.  Full Article

Alkermes PLC announces initiation of Forward-5 clinical study of ALKS 5461 for treatment of major depressive disorder
Wednesday, 30 Jul 2014 07:00am EDT 

Alkermes PLC:Announces the initiation of FORWARD-5, the third of three core efficacy studies planned in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of depressive disorder.Study will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs for depression.About two-thirds of patients who are diagnosed with MDD do not adequately respond to initial antidepressant therapy.  Full Article

Alkermes PLC announces initiation of phase 1 clinical study of ALKS 8700 for treatment of multiple sclerosis
Thursday, 17 Jul 2014 07:00am EDT 

Alkermes PLC:Initiation of phase 1 clinical study of ALKS 8700, monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS).Randomized, double-blind study will evaluate the safety, tolerability and pharmacokinetics of several oral formulations of ALKS 8700 compared to both placebo and active control groups in about 125 healthy volunteers.ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to marketed dimethyl fumarate, TECFIDERA((reg)).This phase 1 study will investigate the pharmacokinetics and pharmacodynamics of multiple formulations and doses of ALKS 8700, and is designed to determine those suitable to progress into advanced clinical testing.Initiation of phase 1 study follows Alkermes' filing of an Investigational New Drug (IND) application with U.S. Food and Drug Administration (FDA).Issuance of composition of matter patent for ALKS 8700 from the United States Patent and Trademark Office (USPTO) in March 2014, which is expected to provide patent protection into 2033.  Full Article

Alkermes PLC presents phase 3 data from successful pivotal study of aripiprazole lauroxil for treatment of schizophrenia
Wednesday, 18 Jun 2014 07:00am EDT 

Alkermes PLC:Presentation of data from its phase 3 clinical trial of aripiprazole lauroxil, an investigational drug candidate in development for schizophrenia, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Hollywood, Fla.In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale (PANSS) score.Says met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo.This is the first demonstration of the efficacy of a range of doses of a long-acting injectable form of aripiprazole in a randomized clinical trial.Says it remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014.  Full Article

Alkermes PLC announces initiation of FORWARD-3 and FORWARD-4 efficacy studies in pivotal program for ALKS 5461 for treatment of major depressive disorder
Tuesday, 10 Jun 2014 07:00am EDT 

Alkermes PLC:Says initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a mechanism of action for adjunctive treatment of major depressive disorder (MDD).Studies will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs.  Full Article

Alkermes PLC announces initiation of second phase 2 clinical study of ALKS 3831
Monday, 2 Jun 2014 07:02am EDT 

Alkermes PLC:Says initiation of second phase 2 clinical study of ALKS 3831, a novel broad-spectrum oral antipsychotic medicine in development for schizophrenia.Randomized, double-blind, active-controlled study will assess ALKS 3831's efficacy, safety and tolerability in treating schizophrenia in patients with co-occurring alcohol use disorder, compared to olanzapine, an approved and widely used atypical antipsychotic medicine.This study is the second in the ALKS 3831 comprehensive phase 2 clinical program; the first phase 2 study was initiated in July 2013 and is designed to evaluate the attenuation of weight gain associated with olanzapine in patients with schizophrenia.Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.(2).  Full Article

Alkermes PLC reaffirms FY 2014 outlook - Conference Call
Wednesday, 30 Apr 2014 08:30am EDT 

Alkermes PLC:Says it remain on track to meet its FY 2014 guidance that it provided in Feb.FY 2014 revenue of $595 mln, EPS of $0.50 - Thomson Reuters I/B/E/S.  Full Article

Alkermes announces positive topline results from pivotal Phase 3 Study of Aripiprazole Lauroxil for treatment of schizophrenia
Tuesday, 8 Apr 2014 07:00am EDT 

Alkermes PLC:Announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia.Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically reductions from baseline in Positive and Negative Syndrome Scale (PANSS).Plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014.  Full Article

Alkermes PLC announces initiation of ALKS 5461 pivotal clinical program for treatment of major depressive disorder
Thursday, 6 Mar 2014 07:00am EST 

Alkermes PLC:Says the initiation of the pivotal clinical development program for ALKS 5461, a once-daily, oral investigational medicine with a mechanism of action for the adjunctive treatment of depressive disorder.The comprehensive pivotal program, named FORWARD, includes a total of 12 studies, including three core phase 3 efficacy studies and nine supportive studies.The first FORWARD study, evaluating the onset of clinical effect, safety and tolerability of ALKS 5461 in about 60 patients with MDD, has begun, and the three core efficacy studies are expected to begin in mid 2014.The FORWARD pivotal program will evaluate the safety and efficacy of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.The company expects to use safety and efficacy data from the FORWARD studies as the basis for a New Drug Application (NDA) to be submitted to the U.S. Food and Drug Administration (FDA), pending study results.  Full Article

Alkermes PLC issues FY 2014 guidance; earnings guidance below analysts' estimates
Thursday, 27 Feb 2014 07:00am EST 

Alkermes PLC:Expects FY 2014 total revenue to be in the range of $580 mln to $610 mln.Expects FY 2014 GAAP net loss in the range of $70 mln to $90 mln, or a basic and diluted loss per share (EPS) of $0.48 to $0.61.Expects FY 2014 non-GAAP net income to range from $65 mln to $85 mln and non-GAAP diluted EPS to range from $0.41 to $0.54.FY 2014 revenue of $587 mln, net income of $126.7 mln and EPS of $0.91 - Thomson Reuters I/B/E/S.  Full Article

Even with Irish address, Alkermes prefers independence

SAN DIEGO - Dublin, Ireland-based Alkermes Plc has the low-tax domicile currently in vogue among multinational pharmaceutical companies but is not interested in being bought out as it nears the launch of new drugs, its chief executive said on Monday.

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