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ALKS

Alkermes

$61.66

1.35 (2.24%)

07:03
06/12/17
06/12
07:03
06/12/17
07:03

Alkermes announces initiation of study 217 for ALKS 5461 for treatment of MDD

Alkermes announced the initiation of study 217, a phase 3b trial of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder. The 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, including selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. In addition to the traditional Montgomery-Asberg Depression Rating Scale for assessing improvement in depression symptoms, study 217 will include scales to further evaluate ALKS 5461's potential benefits on mood and associated behavioral domains known to be regulated by endogenous opioid modulation. The company also reiterated plans to submit a New Drug Application for ALKS 5461 for the adjunctive treatment of MDD to the U.S. FDA by year-end 2017. Study 217 is a phase 3b, multinational, randomized, double-blind, placebo-controlled clinical trial that will evaluate the efficacy, safety and tolerability of ALKS 5461 as adjunctive treatment in patients with MDD. The 11-week, 2-stage study will randomize up to 325 patients and incorporates design features informed by the FORWARD pivotal program to help ensure rigorous patient selection, monitoring and evaluation. The primary objective of the study is to assess ALKS 5461's ability to improve depressive symptoms, as measured by MADRS-6 and MADRS-10. Specific scales to evaluate additional potential benefits of ALKS 5461 included in study 217 are the Connor-Davidson Resilience Scale, Snaith-Hamilton Pleasure Scale, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Brief Pain Inventory-Short Form, and the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales.

  • 13

    Jun

ALKS Alkermes
$61.66

1.35 (2.24%)

05/01/17
FBCO
05/01/17
NO CHANGE
Target $70
FBCO
Outperform
Alkermes price target lowered to $70 from $78 at Credit Suisse
Credit Suisse analyst Vamil Divan lowered his price target for Alkermes to $78 from $70 after Q1 results. The analyst reiterates an Outperform rating, and notes that his enthusiasm on Alkermes remains driven by the upside he expects from Vivitrol in the near to mid-term and then the pipeline over time.
05/18/17
LEER
05/18/17
NO CHANGE
LEER
Outperform
Leerink sees 'multiple approvability questions' for Alkermes in depression
Leerink analyst Paul Matteis believes "multiple approvability questions" remain after Alkermes this morning presented additional clinical data for ALKS 5461 in treatment resistant depression. The FDA's acceptance of a novel trial design and tweaked clinical endpoint are among the outstanding issues, Matteis tells investors in a research note. Today's data are unlikely to "materially shift the debate in the short term," the analyst adds. Matteis, however, remains "encouraged by the breadth of precedent for FDA flexibility in psychiatry" ahead of an ALKS 5461 new drug application filing in the second half of the year. He reiterates an Outperform rating on Alkermes. The stock in afternoon trading is up 57c to $57.79.
05/19/17
FBCO
05/19/17
NO CHANGE
Target $70
FBCO
Outperform
Alkermes added depression drug data a positive, says Credit Suisse
Credit Suisse analyst Vamil Divan said he views the additional ALKS 5461 FORWARD-5 study data that Alkermes presented as an incremental positive, adding that the safety profile of the prospective depression treatment also seems clean. A "leading psychiatrist" that Divan met with now feels more comfortable that the data for ALKS 5461 should be sufficient for FDA approval, the analyst tells investors. He keeps an Outperform rating and $70 target price on Alkermes shares.
06/06/17
LEER
06/06/17
NO CHANGE
LEER
Outperform
Alkermes approval brings 'much-needed boost,' says Leerink
The FDA's approval of a two-month dose duration option for Alkermes' Aristada adds to the long-acting injectable formulation of aripiprazole's advantages over Otsuka's Abilify Maintena, Leerink analyst Paul Matteis tells investors in a research note. The approval adds a "much-needed boost" to the franchise as the launch has been off to a "slow, below consensus start," the analyst writes. He remains optimistic that Aristada will capture market share and reiterates an Outperform rating on Alkermes.

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