Key Developments: Alkermes Plc (ALKS.O)

ALKS.O on Nasdaq

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26 Dec 2014
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Latest Key Developments (Source: Significant Developments)

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

Alkermes PLC announces direct offering of 5,917,160 ordinary shares-Form 8-K
Monday, 13 Jan 2014 07:31am EST 

Alkermes PLC:Says on Jan. 10, the company entered into a pricing term sheet with Invesco Perpetual Income Fund (IPI Fund) and Invesco Perpetual High Income Fund (IPHI Fund and, together with IPI Fund, the Funds).Says acting through Invesco Asset Management Limited in its capacity as agent for and on behalf of the Funds for the registered direct offering of 5,917,160 ordinary shares of the company, $0.01 par value (the Shares), at a purchase price of $42.25 per Share.Says the Shares will be issued pursuant to a prospectus supplement filed with the Securities and Exchange Commission on Jan. 13, in connection with a takedown from shelf registration statement on Form S-3 (File no. 333-192256), which became effective on Nov. 12, 2013.Says the closing of the transaction is expected to occur on or about Jan.16.Says the gross offering proceeds are expected to be about $250 million, before deducting the estimated offering expenses.  Full Article

Alkermes PLC Announces Initiation of Phase 2 Clinical Study of ALKS 3831
Wednesday, 17 Jul 2013 12:29pm EDT 

Alkermes PLC announced the initiation of a phase 2 study of ALKS 3831, oral atypical antipsychotic drug candidate designed to be a broad spectrum treatment for schizophrenia. The double-blind, active-controlled, dose-ranging study in approximately 400 patients with schizophrenia will assess ALKS 3831, a combination of opioid modulator, ALKS 33, and olanzapine, an approved atypical antipsychotic medicine, compared to olanzapine alone. In addition to safety and tolerability, the phase 2 study is designed to evaluate the impact of ALKS 3831 on weight and other metabolic factors in patients and confirm the attenuation of olanzapine-induced weight gain observed in the phase 1 study of ALKS 3831. The ALKS 3831 comprehensive phase 2 clinical program is comprised of two separate studies, including the study announced focused on the attenuation of weight gain associated with olanzapine. 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.1 The second phase 2 study will investigate the potential utility of ALKS 3831 for the large number of patients with the dual diagnosis of schizophrenia and substance abuse disorder, a group representing as many as 50% of patients with schizophrenia.  Full Article

Alkermes PLC Announces Data On Alks 5461 And Alks 3831 To Be Presented At 53rd Annual NCDEU Meeting
Wednesday, 22 May 2013 07:00am EDT 

Alkermes PLC announced that clinical data on ALKS 5461, a drug candidate for depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, and ALKS 3831, a antipsychotic candidate for the treatment of schizophrenia, are scheduled to be presented at the 53rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla., May 28-31, 2013. ALKS 5461 is a investigational medicine with a mechanism for the treatment of depressive disorder (MDD). The mechanism of action for ALKS 5461 in the treatment of depressive symptoms is based on modulation of the opioid system in the brain, employing a balanced combination of agonism and antagonism of opioid receptors. ALKS 5461 consists of buprenorphine, a partial agonist, and ALKS 33, a potent mu-opioid antagonist, and is designed to be a once-daily, non-addictive medicine. ALKS 3831 is a investigational medicine designed as a broad spectrum treatment for schizophrenia. ALKS 3831 is comprised of ALKS 33, a opioid modulator that acts as a potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, and offer the therapeutic benefits of olanzapine to a wider range of patients with schizophrenia. ALKS 3831 will also be studied to evaluate its utility in patients with schizophrenia and comorbid substance abuse.  Full Article

Alkermes PLC Announces Positive Results from Phase2 Clinical Study of ALKS 5461 for Major Depressive Disorder
Wednesday, 17 Apr 2013 07:00am EDT 

Alkermes PLC announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. ALKS 5461 reflects a new approach to the treatment of MDD based on modulation of opioid receptors in the brain and is designed as a non-addictive, oral, once-daily medicine. Data from the study showed that ALKS 5461 significantly reduced depressive symptoms across a range of standard measures including the study's primary outcome measure, the Hamilton Depression Rating Scale (HAM-D17) (p=0.026), the Montgomery-├ůsberg Depression Rating Scale (MADRS) (p=0.004) and the Clinical Global Impression, Severity Scale (CGI-S) (p=0.035). ALKS 5461 was generally well tolerated. Based on these results, as well as the positive phase 1/2 results previously reported, Alkermes plans to request a meeting with the U.S. Food and Drug Administration (FDA) and advance ALKS 5461 into a pivotal development program. Data from this phase 2 study will be presented at the 53rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla., May 28, 2013- May 31, 2013.  Full Article

Elan Corporation PLC's Subsidiary Sells Remaining Stake In Alkermes Plc
Thursday, 31 Jan 2013 04:29pm EST 

Elan Corporation PLC announced that, following the close of trading, Elan, through its wholly-owned subsidiary, Elan Science Three Limited, agreed to sell, on customary terms, all of its remaining 7,750,000 ordinary shares of Alkermes plc (Alkermes) through Jefferies & Company Inc. pursuant to Rule 144 under the U.S. Securities Act of 1933. The sale is expected to close on February 6, 2013.  Full Article

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