We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Alkermes Boasts Strong Portfolio and Impressive Pipeline
Read MoreHide Full Article
We issued an updated research report on Alkermes plc. (ALKS - Free Report) on Oct 16.
Alkermes’ revenues are being driven by its proprietary products, Vivitrol and Aristada, and five partnered products — Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza/Trevicta, Ampyra/Fampyra and Bydureon. We expect these products to continue contributing to the company’s top-line growth in the coming quarters.
Aristada is growing impressively in a long-acting injectable (LAI) market. The United States LAI market could cross $4 billion in 2020. The company expects Aristada net sales to double to $140-$160 million in 2018.
On Jul 2, the FDA approved Aristada Initio extended-release product for the treatment of schizophrenia in adults. The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one, which plays a significant role to treat a complex disease like schizophrenia.
The company’s progress with pipeline candidates targeting major CNS disorders, such as schizophrenia, addiction, depression and multiple sclerosis, has been impressive. An important pipeline candidate is ALKS 5461, being developed for the treatment of major depressive disorder (MDD). On Apr 16, the FDA accepted for review the new drug application (NDA) for ALKS 5461. The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate, stating that the NDA did not have enough evidence for the oral medication to work. The FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication. The FDA has set an action date of Jan 31, 2019.
Another interesting candidate is ALKS 3831, which is in phase III for the treatment of schizophrenia. Top-line data is expected in the fourth quarter of 2018 and if the study is positive, the company expects to submit the NDA in the first half of 2019. The candidate is also in a phase I metabolic study to assess its effects on insulin sensitivity, lipid metabolism and other important metabolic parameters compared with Eli Lilly and Company’s (LLY - Free Report) Zyprxa.
In September 2018, Alkermes announced that it has expanded its ongoing phase I study for ALKS 4230, an immuno-oncology drug candidate, to evaluate its safety and anti-tumor activity when administered in combination with Merck & CO.’s (MRK - Free Report) PD-1 inhibitor Keytruda (pembrolizumab) in patients with advanced solid tumors.
BIIB098 (initially known as ALKS 8700) is being developed in collaboration with Biogen Inc. (BIIB - Free Report) to treat relapsing forms of multiple sclerosis (MS). Alkermes expects to submit a new drug application (NDA) for BIIB098 to the FDA later in 2018. Alkermes may also receive a $150-million milestone payment from Biogen upon the FDA approval of the NDA for BIIB098, on or before Dec 31, 2021.
Successful development and subsequent commercialization of these candidates would be a huge boost for the company.
However, Alkermes is highly dependent on manufacturing and/or royalty revenues.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
Image: Bigstock
Alkermes Boasts Strong Portfolio and Impressive Pipeline
We issued an updated research report on Alkermes plc. (ALKS - Free Report) on Oct 16.
Alkermes’ revenues are being driven by its proprietary products, Vivitrol and Aristada, and five partnered products — Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza/Trevicta, Ampyra/Fampyra and Bydureon. We expect these products to continue contributing to the company’s top-line growth in the coming quarters.
Aristada is growing impressively in a long-acting injectable (LAI) market. The United States LAI market could cross $4 billion in 2020. The company expects Aristada net sales to double to $140-$160 million in 2018.
On Jul 2, the FDA approved Aristada Initio extended-release product for the treatment of schizophrenia in adults. The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one, which plays a significant role to treat a complex disease like schizophrenia.
The company’s progress with pipeline candidates targeting major CNS disorders, such as schizophrenia, addiction, depression and multiple sclerosis, has been impressive. An important pipeline candidate is ALKS 5461, being developed for the treatment of major depressive disorder (MDD). On Apr 16, the FDA accepted for review the new drug application (NDA) for ALKS 5461. The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate, stating that the NDA did not have enough evidence for the oral medication to work. The FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication. The FDA has set an action date of Jan 31, 2019.
Another interesting candidate is ALKS 3831, which is in phase III for the treatment of schizophrenia. Top-line data is expected in the fourth quarter of 2018 and if the study is positive, the company expects to submit the NDA in the first half of 2019. The candidate is also in a phase I metabolic study to assess its effects on insulin sensitivity, lipid metabolism and other important metabolic parameters compared with Eli Lilly and Company’s (LLY - Free Report) Zyprxa.
In September 2018, Alkermes announced that it has expanded its ongoing phase I study for ALKS 4230, an immuno-oncology drug candidate, to evaluate its safety and anti-tumor activity when administered in combination with Merck & CO.’s (MRK - Free Report) PD-1 inhibitor Keytruda (pembrolizumab) in patients with advanced solid tumors.
BIIB098 (initially known as ALKS 8700) is being developed in collaboration with Biogen Inc. (BIIB - Free Report) to treat relapsing forms of multiple sclerosis (MS). Alkermes expects to submit a new drug application (NDA) for BIIB098 to the FDA later in 2018. Alkermes may also receive a $150-million milestone payment from Biogen upon the FDA approval of the NDA for BIIB098, on or before Dec 31, 2021.
Successful development and subsequent commercialization of these candidates would be a huge boost for the company.
However, Alkermes is highly dependent on manufacturing and/or royalty revenues.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>