Alkermes Plc (ALKS.O) Key Developments | Reuters.com
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Alkermes Plc (ALKS.O)

ALKS.O on Nasdaq

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1 Jul 2016
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Latest Key Developments (Source: Significant Developments)

Alkermes PLC announces sale of Gainesville, GA Manufacturing Facility to Recro Pharma, Inc.
Monday, 9 Mar 2015 06:00am EDT 

Alkermes PLC:Enters into a definitive agreement to sell its manufacturing facility in Gainesville, GA, the manufacturing and royalty revenue associated with products manufactured at the facility and global rights to Meloxicam IV/IM to Recro Pharma, Inc.Under the terms of the agreement, Alkermes will receive from Recro an initial cash payment of $50 mln, development and commercialization milestone payments of up to $120 mln related to Meloxicam IV/IM and low double-digit royalties on net sales of Meloxicam IV/IM.Transaction is anticipated to close in the second quarter of 2015.  Full Article

Alkermes PLC announces New Drug Candidate, ALKS 7119, for Treatment of Alzheimer’s Agitation, Depression and Other CNS Diseases
Monday, 2 Mar 2015 07:00am EST 

Alkermes PLC:Announced a new drug candidate, ALKS 7119, for the treatment of agitation in patients with Alzheimer`s disease, major depressive disorder (MDD) and other central nervous system (CNS) indications.Says it has successfully completed preclinical development and expects to initiate the first clinical study of ALKS 7119 in the Q3 2015.  Full Article

Alkermes PLC gives FY 2015 guidance; revenue and EPS guidance below analysts' estimates
Tuesday, 24 Feb 2015 07:01am EST 

Alkermes PLC:Expects FY 2015 total revenues to range from $640 million to $670 million.Expects FY 2015 GAAP net loss in the range of $255 million to $285 million, or a basic and diluted loss per share of $1.70 to $1.90.Expects FY 2015 non-GAAP net loss in the range of $40 million to $60 million, and non-GAAP basic and diluted EPS to range from $0.27 to $0.40.FY 2015 revenue of $674 million, net income of $40 million and EPS of $0.20 - Thomson Reuters I/B/E/S.  Full Article

Alkermes PLC announces results from Phase 1 Study of ALKS 7106
Tuesday, 24 Feb 2015 07:00am EST 

Alkermes PLC:Says it announces results from phase 1 clinical study of ALKS 7106, new molecule intended for treatment of pain.Says the randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability and pharmacokinetics of single escalating doses of ALKS 7106 in 64 healthy adults.Data from study showed that ALKS 7106 did not meet it's pre-specified criteria for advancing into phase 2 clinical trials.Based on this evaluation, Alkermes will not pursue further development of ALKS 7106.  Full Article

Alkermes PLC announces positive topline results from phase 1 study of ALKS 8700 for treatment of multiple Sclerosis
Monday, 9 Feb 2015 07:00am EST 

Alkermes PLC:Announces positive topline results from a phase 1, randomized, double-blind clinical study of ALKS 8700, a monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS).Says ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA.The study evaluated the safety, tolerability and single-dose pharmacokinetics (PK) of several oral formulations of ALKS 8700 compared to both placebo and active control groups in 104 healthy volunteers.Data from the phase 1 study showed that ALKS 8700 was generally well tolerated and provided MMF exposures comparable to TECFIDERA, with less variability and improved gastrointestinal (GI) tolerability.The most common adverse events (AEs) were flushing and GI-related.Based on the positive results from the study, Alkermes will request a meeting with the U.S. Food and Drug Administration (FDA), and plans to advance ALKS 8700 with twice-daily dosing into pivotal development in 2015.  Full Article

Alkermes PLC announces positive results of phase 2 clinical trial of ALKS 3831 in Schizophrenia
Wednesday, 7 Jan 2015 07:00am EST 

Alkermes PLC:Says positive topline results from 12-week, randomized, double-blind, active-controlled, dose-ranging stage of a phase 2 study of ALKS 3831.ALKS 3831is an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.ALKS 3831 is composed of samidorphan, novel, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine.Data from 300-patient study showed that ALKS 3831 achieved study`s primary efficacy endpoint, demonstrating equivalence to olanzapine in reduction from baseline in Positive and Negative Syndrome Scale total scores at Week 12.ALKS 3831 also met principal pre-specified secondary endpoint of study.Specified secondary endpoint of study demonstrating 37 pct lower mean weight gain compared to olanzapine at Week 12 in full study population and 51 pct lower mean weight gain compared to olanzapine at Week 12 in pre-specified subset of patients.ALKS 3831 was generally well tolerated in the study.Says most common adverse events in ALKS 3831 treatment groups relative to olanzapine were somnolence, sedation and dizziness.Based on positive results from this phase 2 study, Alkermes plans to request an End-of-Phase 2 meeting with U.S. FDA and advance ALKS 3831 into pivotal development program in 2015.  Full Article

Alkermes PLC announces positive results from study of ALKS 5461 for treatment of major depressive
Tuesday, 6 Jan 2015 07:00am EST 

Alkermes PLC:Says topline results from FORWARD-1, one of series of supportive clinical studies in comprehensive FORWARD phase 3 pivotal program for ALKS 5461, once-daily, oral investigational medicine with novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).Says FORWARD-1 study was designed to evaluate safety and tolerability of two titration schedules of ALKS 5461.In addition, study assessed efficacy of ALKS 5461 over an eight-week period, compared to baseline, in patients with MDD.Data from 66-patient study showed that ALKS 5461 was generally well tolerated in both of two titration schedules evaluated - one-week and two-week dose escalation schedules.Most common adverse events in study were nausea, constipation and dry mouth.These findings were consistent with the safety and tolerability profile seen in 142-patient phase 2 study completed in 2013.Additionally, exploratory efficacy analyses showed that ALKS 5461 significantly reduced depressive symptoms from baseline starting at Week One and continued to end of treatment period at Week Eight in patients who received either of two titration schedules.Observed changes from baseline were clinically meaningful and statistically significant (p<0.001).These data support one-week titration schedule being utilized in core phase 3 efficacy studies in FORWARD program.  Full Article

Alkermes PLC announces initiation of clinical study of extended durations of Aripiprazole Lauroxil for treatment of Schizophrenia
Monday, 15 Dec 2014 07:00am EST 

Alkermes PLC:Says initiation of a phase 1 clinical study of extended dosing intervals of aripiprazole lauroxil, the company's investigational, novel, long-acting injectable atypical antipsychotic for the treatment of schizophrenia.Randomized, open-label study of about 140 patients with schizophrenia will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil administered over two new extended durations - once every six weeks, and once every two months.  Full Article

Alkermes PLC reaffirms FY 2014 guidance
Wednesday, 29 Oct 2014 07:00am EDT 

Alkermes PLC:Reaffirms FY 2014 revenue guidance to range from $580-$610 mln.Expects FY 2014 GAAP net loss to range from $50-$70 million or a basic and diluted loss per share of about $0.34-$0.48.Expects FY 2014 non-GAAP net income to range from $30-$50 mln and non-GAAP diluted EPS to a range from $0.19-$0.32.FY 2014 revenue of $600.9 mln, net income of $36.8 mln and EPS of $0.27 - Thomson Reuters I/B/E/S.  Full Article

Alkermes PLC announces new drug application for Aripiprazole Lauroxil
Wednesday, 22 Oct 2014 07:00am EDT 

Alkermes PLC:Says the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, the company's investigational, novel, once-monthly injectable atypical antipsychotic for the treatment of schizophrenia.Under the Prescription Drug User Fee Act (PDUFA), the FDA's target action date for the aripiprazole lauroxil NDA is Aug. 22, 2015.  Full Article

BRIEF-Alkermes appoints Nancy Snyderman to board of directors

* Alkermes appoints Nancy Snyderman to board of directors Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +1 646 223 8780)