Edition:
United States

Alkermes Plc (ALKS.O)

ALKS.O on Nasdaq

55.74USD
23 Jan 2017
Change (% chg)

-- (--)
Prev Close
$55.74
Open
--
Day's High
--
Day's Low
--
Volume
--
Avg. Vol
1,080,854
52-wk High
$60.74
52-wk Low
$27.14

Latest Key Developments (Source: Significant Developments)

Alkermes PLC raises FY 2015 guidance
Thursday, 30 Jul 2015 07:00am EDT 

Alkermes PLC:Expects FY 2015 total revenues to range from $610 million to $640 million, up from the previous range of $600 million to $630 million.Expects FY 2015 GAAP net loss to range from $245 million to $270 million, or a basic and diluted loss per share of $1.63 to $1.80.Says this compares to previous expectations of GAAP net loss in the range of $270 million to $300 million, or a basic and diluted loss per share of about $1.80 to $2.00.Expects FY 2015 non-GAAP net loss to range from $47 million to $67 million, or a basic and diluted loss per share of $0.31 to $0.45.Says this compares to previous expectations of non-GAAP net loss in the range of $55 million to $75 million, or a non-GAAP diluted loss per share of $0.37 to $0.50.  Full Article

Recro Pharma Inc completes acquisition of IV/IM Meloxicam and cGMP manufacturing facility and business unit from Alkermes Plc
Monday, 13 Apr 2015 07:00am EDT 

Recro Pharma Inc:Says completion of its previously said acquisition of assets from Alkermes Plc and its affiliates.Including worldwide rights to IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain and contract manufacturing facility, royalty and formulation business.  Full Article

Alkermes PLC announces positive topline results from complete six-month Phase 2 Clinical Trial of ALKS 3831 in Schizophrenia
Monday, 6 Apr 2015 07:00am EDT 

Alkermes PLC:Says positive topline results from the complete, six-month, randomized, dose-ranging phase 2 study of ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.  Full Article

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

BRIEF-Alkermes inspiration grants awarded to support people affected by mental health and substance use disorders

* Alkermes inspiration grants(tm) awarded to support people affected by mental health and substance use disorders Source text for Eikon: Further company coverage: