Alkermes plc ALKS announced that it has initiated the phase II Vibrance-3 study, evaluating the novel, investigational and oral orexin 2 receptor agonist, ALKS 2680, in adults with idiopathic hypersomnia (“IH”), a rare, chronic and neurological sleep disorder.
The double-blind, placebo-controlled study will evaluate the safety and efficacy of ALKS 2680 compared with placebo in adults with IH. The primary endpoint of the Vibrance-3 study will check, by dose level, whether treatment with ALKS 2680 leads to a greater decrease in sleepiness versus placebo alone, as measured by the change in Epworth Sleepiness Scale score.
In the study, participants will be randomized to receive one of the three doses of ALKS 2680 (10 mg, 14 mg or 18 mg) or placebo to be taken once daily for eight weeks.
Secondary endpoints of the Vibrance-3 study are changes in the Idiopathic Hypersomnia Severity Scale score and incidence of adverse events.
ALKS' Price Performance
Year to date, shares of Alkermes have gained 13.1% compared with the industry’s rise of 2.4%.
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ALKS' Other Ongoing Studies on ALKS 2680
Besides IH, ALKS 2680 is also being developed for the treatment of narcolepsy type 1 and type 2.
The phase II Vibrance-1 study is investigating ALKS 2680 for treating adults with narcolepsy type 1 (NT1).
Apart from this, the phase II Vibrance-2 study is evaluating the safety and efficacy of ALKS 2680 versus placebo in adults with narcolepsy type 2 (NT2).
Data from both studies is expected in the second half of 2025. If successfully developed and upon potential approval, ALKS 2680 can serve an area of high unmet medical need in the treatment of NT1 and NT2 as well as IH.
However, upon potential approval, ALKS 2680 is likely to face competition from Axsome’s AXSM Sunosi (solriamfetol), which is presently marketed in the United States for the treatment of narcolepsy.
Several label expansion studies on solriamfetol are also currently underway.
Axsome acquired the U.S. rights for Sunosi from Jazz Pharmaceuticals JAZZ in May 2022. AXSM began selling Sunosi in the U.S. market in May 2022.
JAZZ received approval for Sunosi as a treatment for narcolepsy in 2019.
Jazz’s other sleep disorder drugs, Xyrem and Xywav, also hold a strong market share.
ALKS' Zacks Rank & Stock to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Krystal Biotech, Inc. KRYS, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.40 to $7.06 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $11. Year to date, shares of KRYS have increased 11.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.
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This article originally published on Zacks Investment Research (zacks.com).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
