Alkermes plc’s ALKS shares hit a 52-week high after the company announced new developments and milestones related to three of its candidates and an approved product for the treatment of central nervous system (CNS) diseases.
The company reported that it has initiated pivotal programs on two of its candidates, ALKS 3831 and ALKS 8700, for the treatment of patients with schizophrenia and multiple sclerosis (MS), respectively.
ALKS 3831 is being evaluated in a multicenter, randomized, double-blind phase III study (ENLIGHTEN-1) in patients experiencing acute exacerbation of schizophrenia. Alkermes plans to evaluate the candidate in comparison to Eli Lilly and Company’s LLY Zyprexa (olanzapine) in the ENLIGHTEN-2 study, which is expected to be initiated in the first quarter of 2016.
The company is currently enrolling patients in the EVOLVE-1 study on ALKS 8700 for MS. A head-to-head study (EVOLVE-2) on ALKS 8700 in comparison with Biogen Inc.’s BIIB Tecfidera is expected to be initiated in mid-2016. The company plans to submit a New Drug Application (NDA) in 2018.
In addition, Alkermes announced positive results from human abuse potential study on ALKS 5461 for the treatment of patients with major depressive disorder (MDD). The company expects to present data from the FORWARD-3 and FORWARD-4 studies in the first quarter of 2016, while results from the FORWARD-5 study is anticipated in mid-2016. ALKS 5461 enjoys Fast Track status in the U.S. as an adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.
Alkermes also announced that the U.S. Patent and Trademark Office New Patent has issued a new patent for Aristada that covers protection till Oct 2033.
We remind investors that in Oct 2015, Aristada was approved in the U.S. as an extended-release injectable suspension for the treatment of patients with schizophrenia.
Alkermes currently carries a Zacks Rank #4 (Sell). Anika Therapeutics Inc. ANIK is a better-ranked stock in the health care sector with a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment