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FDA Grants Breakthrough Therapy Designation to ALKS' Narcolepsy Drug
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Key Takeaways
Alkermes said the FDA granted Breakthrough status to alixorexton for narcolepsy type 1.
ALKS' Vibrance-1 phase II study met its primary endpoint, improving wakefulness versus placebo.
Alkermes plans a global phase III program on alixorexton for narcolepsy in Q1 2026.
Alkermes (ALKS - Free Report) announced that the FDA has granted Breakthrough Therapy Designation to alixorexton, a novel, investigational, and oral orexin 2 receptor agonist (formerly ALKS 2680), for the treatment of patients with narcolepsy type 1 (NT1).
The FDA’s Breakthrough Therapy designation is intended to facilitate drug development and expedite the review of therapies for serious diseases with unmet medical needs.
NT1 is a chronic sleep disorder causing excessive daytime sleepiness and sudden muscle weakness called cataplexy due to orexin deficiency.
Over the past year, ALKS’ shares have risen 1.3% compared with the industry’s 14.2% rise.
Image Source: Zacks Investment Research
Breakthrough Tag Based on Alkermes’ Vibrance Study Data
The Breakthrough Therapy designation for alixorexton in NT1 is based on top-line positive data from the phase I and phase II Vibrance-1 study. The phase II study demonstrated that alixorexton achieved statistically significant, clinically meaningful, and dose-dependent improvements from baseline in wakefulness, as measured by the Maintenance of Wakefulness Test, compared with placebo across all dose levels, meeting the primary endpoint.
Treatment with alixorexton also reduced excessive daytime sleepiness versus placebo at week six, on the Epworth Sleepiness Scale, a key secondary endpoint of the Vibrance-1 study. The candidate was generally safe and well-tolerated across all doses.
More on ALKS’ Alixorexton
Besides NT1, alixorexton is also being studied for the treatment of narcolepsy type 2 (“NT2”) and idiopathic hypersomnia (“IH”).
Alkermes announced positive top-line data from the phase II Vibrance-2 study evaluating alixorexton in patients with NT2 in November 2025.
The study showed statistically significant and clinically meaningful improvements in wakefulness and reductions in excessive daytime sleepiness versus placebo in patients with NT2 and met the primary endpoints.
Alixorexton was generally well-tolerated at all doses tested.
Narcolepsy Type 2 is a neurological sleep disorder causing excessive daytime sleepiness and sudden sleep attacks.
In April 2025, the company initiated the phase II Vibrance-3 study, evaluating the safety and efficacy of alixorexton in adults with idiopathic hypersomnia, a rare, chronic, and neurological sleep disorder.
Building on the overall success of the Vibrance-1 and Vibrance-2 studies, Alkermes is planning to initiate a global phase III program for alixorexton in narcolepsy in the first quarter of 2026.
Per management, if successfully developed, alixorexton has the potential to address a significant unmet need in the treatment of NT1 and NT2 as well as IH.
Alkermes’ Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Century Therapeutics’ 2026 loss per share have narrowed from $1.17 to $1.09. Shares of IPSC have declined 15.9% over the past year.
Century Therapeutics’ earnings beat estimates in three of the trailing four quarters and were in line in the remaining quarter, with the average surprise being 102.37%.
Over the past 60 days, 2026 EPS estimates for CorMedix have risen from $2.49 to $2.88. Shares of CRMD have risen 4.2% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, estimates for Indivior’s 2026 earnings per share have risen to $2.85 from $2.60. Indivior stock has rallied 199.3% over the past year.
Indivior’s earnings beat estimates in three of the trailing four quarters and were in line in the remaining quarter, with the average surprise being 68%.
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FDA Grants Breakthrough Therapy Designation to ALKS' Narcolepsy Drug
Key Takeaways
Alkermes (ALKS - Free Report) announced that the FDA has granted Breakthrough Therapy Designation to alixorexton, a novel, investigational, and oral orexin 2 receptor agonist (formerly ALKS 2680), for the treatment of patients with narcolepsy type 1 (NT1).
The FDA’s Breakthrough Therapy designation is intended to facilitate drug development and expedite the review of therapies for serious diseases with unmet medical needs.
NT1 is a chronic sleep disorder causing excessive daytime sleepiness and sudden muscle weakness called cataplexy due to orexin deficiency.
Over the past year, ALKS’ shares have risen 1.3% compared with the industry’s 14.2% rise.
Image Source: Zacks Investment Research
Breakthrough Tag Based on Alkermes’ Vibrance Study Data
The Breakthrough Therapy designation for alixorexton in NT1 is based on top-line positive data from the phase I and phase II Vibrance-1 study. The phase II study demonstrated that alixorexton achieved statistically significant, clinically meaningful, and dose-dependent improvements from baseline in wakefulness, as measured by the Maintenance of Wakefulness Test, compared with placebo across all dose levels, meeting the primary endpoint.
Treatment with alixorexton also reduced excessive daytime sleepiness versus placebo at week six, on the Epworth Sleepiness Scale, a key secondary endpoint of the Vibrance-1 study. The candidate was generally safe and well-tolerated across all doses.
More on ALKS’ Alixorexton
Besides NT1, alixorexton is also being studied for the treatment of narcolepsy type 2 (“NT2”) and idiopathic hypersomnia (“IH”).
Alkermes announced positive top-line data from the phase II Vibrance-2 study evaluating alixorexton in patients with NT2 in November 2025.
The study showed statistically significant and clinically meaningful improvements in wakefulness and reductions in excessive daytime sleepiness versus placebo in patients with NT2 and met the primary endpoints.
Alixorexton was generally well-tolerated at all doses tested.
Narcolepsy Type 2 is a neurological sleep disorder causing excessive daytime sleepiness and sudden sleep attacks.
In April 2025, the company initiated the phase II Vibrance-3 study, evaluating the safety and efficacy of alixorexton in adults with idiopathic hypersomnia, a rare, chronic, and neurological sleep disorder.
Building on the overall success of the Vibrance-1 and Vibrance-2 studies, Alkermes is planning to initiate a global phase III program for alixorexton in narcolepsy in the first quarter of 2026.
Per management, if successfully developed, alixorexton has the potential to address a significant unmet need in the treatment of NT1 and NT2 as well as IH.
Alkermes’ Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the biotech sector are Century Therapeutics (IPSC - Free Report) , CorMedix (CRMD - Free Report) , and Indivior (INDV - 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 Century Therapeutics’ 2026 loss per share have narrowed from $1.17 to $1.09. Shares of IPSC have declined 15.9% over the past year.
Century Therapeutics’ earnings beat estimates in three of the trailing four quarters and were in line in the remaining quarter, with the average surprise being 102.37%.
Over the past 60 days, 2026 EPS estimates for CorMedix have risen from $2.49 to $2.88. Shares of CRMD have risen 4.2% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, estimates for Indivior’s 2026 earnings per share have risen to $2.85 from $2.60. Indivior stock has rallied 199.3% over the past year.
Indivior’s earnings beat estimates in three of the trailing four quarters and were in line in the remaining quarter, with the average surprise being 68%.