We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
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.
ALKS' Sleep Disorder Drug Gets Orphan Drug Tags in the U.S. & Europe
Read MoreHide Full Article
Key Takeaways
ALKS received FDA orphan drug status for alixorexton to treat idiopathic hypersomnia.
ALKS also secured European orphan drug designation for alixorexton in narcolepsy patients.
ALKS is advancing alixorexton across narcolepsy type 1, type 2 and idiopathic hypersomnia.
Alkermes (ALKS - Free Report) announced that the FDA has granted an orphan drug designation (ODD) to its novel, investigational and oral orexin 2 receptor agonist, alixorexton (formerly ALKS 2680), for the treatment of idiopathic hypersomnia (IH).
Simultaneously, the European Commission granted ODD to alixorexton for the treatment of patients with narcolepsy.
Granted by the FDA, ODD is a special status to promote new drugs or indications for existing drugs to treat, prevent or diagnose rare diseases affecting a small percentage of the population. In the United States, the ODD offers various incentives, including tax credits for clinical study costs and waivers of certain FDA application fees and seven years of market exclusivity upon potential approval.
In the European Union, orphan designation provides regulatory and commercial benefits, including protocol assistance, lower regulatory fees, and up to 10 years of market exclusivity upon approval.
ALKS’ Price Performance
Year to date, shares of Alkermes have rallied 58.5% against the industry’s decline of 0.7%.
Image Source: Zacks Investment Research
ALKS’ Recent Updates With Alixorexton Development
Alkermes is developing alixorexton for the treatment of narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) and IH.
In January 2026, the FDA granted Breakthrough Therapy Designation to alixorexton for the treatment of patients with NT1.
NT1 is a chronic sleep disorder causing excessive daytime sleepiness and sudden muscle weakness called cataplexy due to orexin deficiency.
The company recently initiated the phase III Brilliance studies, evaluating the safety and efficacy of alixorexton versus placebo in adults with NT1 and NT2.
NT2 is a neurological sleep disorder causing excessive daytime sleepiness and sudden sleep attacks.
The program consists of three 12-week, placebo-controlled phase III studies evaluating once-daily and split-dose regimens of alixorexton.
Meanwhile, the phase II Vibrance-3 study continues to evaluate alixorexton for treating adults with IH.
Management believes that, if successfully developed, alixorexton has the potential to address a significant unmet need in the treatment of NT1 and NT2 as well as IH.
ALKS’ Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have increased 26.9% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 108.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
View the Zacks #1 Rank List
Image: Bigstock
ALKS' Sleep Disorder Drug Gets Orphan Drug Tags in the U.S. & Europe
Key Takeaways
Alkermes (ALKS - Free Report) announced that the FDA has granted an orphan drug designation (ODD) to its novel, investigational and oral orexin 2 receptor agonist, alixorexton (formerly ALKS 2680), for the treatment of idiopathic hypersomnia (IH).
Simultaneously, the European Commission granted ODD to alixorexton for the treatment of patients with narcolepsy.
Granted by the FDA, ODD is a special status to promote new drugs or indications for existing drugs to treat, prevent or diagnose rare diseases affecting a small percentage of the population. In the United States, the ODD offers various incentives, including tax credits for clinical study costs and waivers of certain FDA application fees and seven years of market exclusivity upon potential approval.
In the European Union, orphan designation provides regulatory and commercial benefits, including protocol assistance, lower regulatory fees, and up to 10 years of market exclusivity upon approval.
ALKS’ Price Performance
Year to date, shares of Alkermes have rallied 58.5% against the industry’s decline of 0.7%.
Image Source: Zacks Investment Research
ALKS’ Recent Updates With Alixorexton Development
Alkermes is developing alixorexton for the treatment of narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) and IH.
In January 2026, the FDA granted Breakthrough Therapy Designation to alixorexton for the treatment of patients with NT1.
NT1 is a chronic sleep disorder causing excessive daytime sleepiness and sudden muscle weakness called cataplexy due to orexin deficiency.
The company recently initiated the phase III Brilliance studies, evaluating the safety and efficacy of alixorexton versus placebo in adults with NT1 and NT2.
NT2 is a neurological sleep disorder causing excessive daytime sleepiness and sudden sleep attacks.
The program consists of three 12-week, placebo-controlled phase III studies evaluating once-daily and split-dose regimens of alixorexton.
Meanwhile, the phase II Vibrance-3 study continues to evaluate alixorexton for treating adults with IH.
Management believes that, if successfully developed, alixorexton has the potential to address a significant unmet need in the treatment of NT1 and NT2 as well as IH.
ALKS’ Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have increased 26.9% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 108.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.