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' (ALKS) Schizophrenia, Bipolar I Disorder Drug Approved
Read MoreHide Full Article
Alkermes plc (ALKS - Free Report) announced that the FDA has approved once-daily, oral atypical antipsychotic drug Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and adults who have bipolar I disorder. It is approved as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.
The company plans to launch Lybalvi in the fourth quarter of 2021. Successful commercialization of the drug will boost Alkermes’ growth prospects in the days ahead.
Shares of Alkermes were up 2.1% on Monday following the announcement. In fact, the stock has rallied 16.1% so far this year against the industry’s decrease of 4.1%.
Image Source: Zacks Investment Research
Schizophrenia is a chronic, severe and disabling brain disorder. Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function.
The FDA nod for Lybalvi was based on data from 27 clinical studies, among which 18 investigated Lybalvi and nine evaluated samidorphan alone as well as safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia.
We note that in December 2020, the FDA accepted the Alkermes’ new drug application (“NDA”) resubmission for Lybalvi for the treatment of adults with schizophrenia and bipolar I disorder.
In November 2020, Alkermes received a Complete Response Letter from the FDA regarding its NDA for Lybalvi. Back then, the company had stated that the agency required the resolution of certain conditions related to the tablet coating process at its facility in Wilmington, OH before the drug could be approved.
Other available drugs in the schizophrenia and bipolar I disorder treatment market include AstraZeneca’s (AZN - Free Report) Seroquel XR, Johnson & Johnson's (JNJ - Free Report) Risperdal Consta and AbbVie’s (ABBV - Free Report) Vraylar.
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Image: Bigstock
Alkermes' (ALKS) Schizophrenia, Bipolar I Disorder Drug Approved
Alkermes plc (ALKS - Free Report) announced that the FDA has approved once-daily, oral atypical antipsychotic drug Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and adults who have bipolar I disorder. It is approved as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.
The company plans to launch Lybalvi in the fourth quarter of 2021. Successful commercialization of the drug will boost Alkermes’ growth prospects in the days ahead.
Shares of Alkermes were up 2.1% on Monday following the announcement. In fact, the stock has rallied 16.1% so far this year against the industry’s decrease of 4.1%.
Image Source: Zacks Investment Research
Schizophrenia is a chronic, severe and disabling brain disorder. Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function.
The FDA nod for Lybalvi was based on data from 27 clinical studies, among which 18 investigated Lybalvi and nine evaluated samidorphan alone as well as safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia.
We note that in December 2020, the FDA accepted the Alkermes’ new drug application (“NDA”) resubmission for Lybalvi for the treatment of adults with schizophrenia and bipolar I disorder.
In November 2020, Alkermes received a Complete Response Letter from the FDA regarding its NDA for Lybalvi. Back then, the company had stated that the agency required the resolution of certain conditions related to the tablet coating process at its facility in Wilmington, OH before the drug could be approved.
Other available drugs in the schizophrenia and bipolar I disorder treatment market include AstraZeneca’s (AZN - Free Report) Seroquel XR, Johnson & Johnson's (JNJ - Free Report) Risperdal Consta and AbbVie’s (ABBV - Free Report) Vraylar.
Zacks Rank
Alkermes currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>