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HC Wainwright Affirms Alkermes (ALKS) ‘Neutral’ Rating on Vibrance-1 Phase 2 Study
Yahoo Finance· 2025-09-18 16:39
Group 1 - Alkermes is recognized as one of the best beginner stocks to buy, with a 'Neutral' rating and a $46 price target from HC Wainwright following positive results from the Vibrance-1 phase 2 study [1][2] - The Vibrance-1 study results indicate that Alixorexton is the first orexin 2 receptor agonist to show a clinically meaningful and statistically significant impact on wakefulness, cognition, and fatigue [2][3] - Improvements in patient-reported outcomes related to fatigue and cognitive function suggest that Alixorexton may provide significant relief for patients suffering from narcolepsy and idiopathic hypersomnia [3] Group 2 - Alkermes is a global biopharmaceutical company focused on developing and commercializing treatments for complex psychiatric and neurological disorders, including addiction, schizophrenia, and bipolar disorder [4] - The company has a diverse portfolio of marketed products and a pipeline of investigational drug candidates, emphasizing its commitment to neuroscience innovation [4]
Alkermes Announces Launch of 8th Annual Alkermes Pathways Research Awards® Program
Prnewswire· 2025-09-11 11:00
Core Points - Alkermes plc is launching its 8th annual Alkermes Pathways Research Awards program, which will accept applications from September 15, 2025, to December 15, 2025, offering individual grants of up to $100,000 per project [1][2][3] - The program aims to support early-career researchers focusing on schizophrenia, bipolar I disorder, and newly included areas of sleep and circadian disturbances associated with these conditions [2][3] - Since its inception in 2018, the program has provided approximately $2.7 million in funding to 27 researchers across the United States [4] Company Overview - Alkermes plc is a mid-cap growth and value equity global biopharmaceutical company focused on developing innovative medicines in neuroscience [5] - The company has a portfolio of proprietary commercial products for treating alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder, along with a pipeline for neurological disorders [5]
Alkermes to Present Detailed Positive Results From Vibrance-1 Phase 2 Study Evaluating Alixorexton in Patients With Narcolepsy Type 1 at World Sleep 2025
Prnewswire· 2025-08-25 11:00
Core Insights - Alkermes plc is set to present detailed results from its Vibrance-1 phase 2 study on alixorexton for narcolepsy type 1 at the World Sleep Congress in Singapore from September 5-10, 2025, and during an investor webcast on September 8, 2025 [1][2][7] Company Overview - Alkermes plc is a mid-cap global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio addressing various neurological disorders including narcolepsy and idiopathic hypersomnia [10] Study Details - The Vibrance-1 study is a phase 2, randomized, double-blind, placebo-controlled trial involving 92 participants, evaluating the safety and efficacy of alixorexton in adults with narcolepsy type 1 [8] - Participants were assigned to receive one of three doses of alixorexton (4 mg, 6 mg, or 8 mg) or placebo once daily for six weeks, with primary and secondary endpoints focusing on wakefulness and other narcolepsy symptoms [8] Presentation Highlights - Three oral presentations will cover the safety and efficacy of alixorexton, improvements in fatigue and cognitive function, and the study design for the Vibrance-3 study evaluating alixorexton in idiopathic hypersomnia [4][5][6] - The presentations will take place during the "Targeting the orexin pathway: Emerging pharmacotherapies for narcolepsy type 1" session on September 8, 2025 [4] Research Community Engagement - The World Sleep Congress will feature leading researchers and clinicians discussing new datasets on orexin 2 receptor agonists, highlighting the ongoing commitment to improving care for patients with hypersomnolence disorders [2][3]
Alkermes Announces Positive Topline Results From Vibrance-1 Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1
Prnewswire· 2025-07-21 10:00
Core Insights - Alixorexton demonstrated clinically meaningful and statistically significant improvements in wakefulness in patients with narcolepsy type 1 compared to placebo [1][2][3] - The drug showed robust improvements in patient-reported outcomes related to disease severity, fatigue, and cognition across all doses tested [1][2] - Alixorexton was generally well tolerated, with no serious adverse events reported during the study [1][5] Study Details - The Vibrance-1 phase 2 study involved 92 patients with narcolepsy type 1, randomized to receive alixorexton at doses of 4 mg, 6 mg, or 8 mg, or placebo for six weeks [2][7] - The primary endpoint was the Maintenance of Wakefulness Test (MWT), where alixorexton showed statistically significant improvements in mean sleep latency at week six (p<0.0001) [3][9] - Secondary endpoints included the Epworth Sleepiness Scale (ESS) and weekly cataplexy rates, with significant improvements noted at the 6 mg dose (p=0.005) [9] Patient-Reported Outcomes - Alixorexton led to significant improvements in excessive daytime sleepiness (ESS) (p<0.0001), narcolepsy symptom severity (NSS) (p<0.001), cognitive complaints (BC-CCI) (p<0.0001), and fatigue (PROMIS-Fatigue) (p<0.01) [9] - The study highlighted the breadth of benefits that alixorexton may provide across multiple facets of narcolepsy, addressing persistent symptoms that disrupt daily life [2] Future Developments - Alkermes plans to present detailed results from the Vibrance-1 study at the World Sleep Congress in September 2025 [6] - The company is moving forward with a global phase 3 program for alixorexton in patients with narcolepsy type 1 based on the positive outcomes from the phase 2 study [2][6]