Alkermes' alixorexton Granted Orphan Drug Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Alkermes announced that alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia, was recently granted orphan drug designations, ODD, from leading regulatory bodies in the U.S. and Europe. The U.S. Food and Drug Administration, FDA, has granted ODD to alixorexton for the treatment of IH, and the European Commission has granted ODD to alixorexton for the treatment of narcolepsy.
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Analyst Views on ALKS
Wall Street analysts forecast ALKS stock price to rise
12 Analyst Rating
10 Buy
2 Hold
0 Sell
Strong Buy
Current: 44.510
Low
37.00
Averages
46.20
High
58.00
Current: 44.510
Low
37.00
Averages
46.20
High
58.00
About ALKS
Alkermes plc is an Ireland-based global biopharmaceutical company that seeks to develop medicines in the field of neuroscience. The Company has a portfolio of commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Its pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. The Company's pipeline includes Olanzapine and samidorphan, Alixorexton, ALKS 4510, ALKS 7290, and Valiloxybate. Its LUMRYZ (sodium oxybate) for extended-release oral suspension is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Alkermes Shares Plunge 31% After Phase 2 Study Results
- Clinical Trial Results: Alkermes reported results from its Phase 2 study of alixorexton for narcolepsy type 2, achieving dual primary endpoints; however, shares plummeted approximately 31% in after-hours trading, indicating a negative market reaction despite the trial's success.
- Primary Endpoint Achievement: The Vibrance-2 trial demonstrated improvements at week eight on the Maintenance of Wakefulness Test and Epworth Sleepiness Scale compared to placebo, with patient-reported wakefulness improvements maintained through a five-week open-label extension, suggesting the drug's potential efficacy.
- Adverse Events: No serious treatment-emergent adverse events were reported during the trial, which may bolster investor confidence in the safety profile of alixorexton, although the stock still faced downward pressure.
- Future Research Plans: Alkermes has initiated a Phase 3 program to examine once-daily and split dosing regimens of alixorexton, reflecting the company's commitment to the long-term development of the drug, despite the short-term negative market response.
See More
Alkermes Reports Positive Phase 2 Results for Alixorexton in Narcolepsy Type 2
- Clinical Trial Success: Alkermes' alixorexton achieved its primary endpoints in the Vibrance-2 phase 2 study involving 93 patients with narcolepsy type 2, demonstrating statistically significant improvements in the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) compared to placebo, indicating its substantial potential in treating narcolepsy.
- Sustained Improvement: Patient-reported enhancements in wakefulness and cognition were maintained throughout the 13-week study, with mean sleep latencies of 14 minutes and 16 minutes for the 14 mg and 18 mg doses respectively at week eight, showcasing significant clinical relevance.
- Good Safety Profile: Alixorexton exhibited favorable tolerability across all tested doses (10 mg, 14 mg, and 18 mg), with over 95% of participants completing the eight-week treatment and no serious treatment-emergent adverse events reported, underscoring its safety in clinical applications.
- Future Development Potential: Following the positive results from Vibrance-2, Alkermes has initiated a global phase 3 program to evaluate alixorexton in patients with narcolepsy type 1 and type 2, highlighting the drug's innovative potential and market prospects in the neuroscience field.
See More
Alkermes Receives Orphan Drug Designation for Alixorexton
- Orphan Drug Designation: Alkermes' alixorexton has received orphan drug designation from the FDA for idiopathic hypersomnia, marking a significant milestone in the drug development process that could expedite market access.
- European Commission Approval: The drug also received orphan drug designation from the European Commission for narcolepsy treatment, which will aid the company's expansion in the European market and enhance its international competitiveness.
- Clinical Trial Progress: Alkermes is currently enrolling patients in the phase 3 Brilliance Studies and completing the phase 2 Vibrance-3 study for alixorexton, with completion expected this year, which could lead to potential revenue growth for the company.
- Market Reaction: Alkermes shares are down 0.18% to $44.20 in pre-market trading on Nasdaq, reflecting a cautious market response to the drug development progress, which may impact investor confidence.
See More
Alkermes Receives FDA Orphan Drug Designation
- Orphan Drug Designation: The US FDA has granted orphan drug designation to Alkermes' alixorexton for idiopathic hypersomnia, highlighting the company's innovative potential in the sleep medicine sector.
- Drug Development Stage: Alixorexton is currently in phase 2 clinical trials as an oral orexin 2 receptor agonist, aimed at alleviating daytime sleepiness symptoms, which could introduce a new treatment option to the market.
- Market Demand Context: Idiopathic hypersomnia is characterized by difficulty waking up in the morning and extreme daytime sleepiness, and as awareness of sleep health increases, the successful development of this drug will meet the growing market demand.
- Strategic Company Implications: The FDA's orphan drug designation not only enhances Alkermes' reputation in the sleep medicine field but may also provide funding and market support for its future commercialization efforts, strengthening its competitive position in the CNS pharmaceutical market.
See More
Alkermes' Lumryz Achieves Key Trial Milestone for Sleep Disorder
- Trial Success: Alkermes announced that its sleep disorder therapy Lumryz met the primary goal in a late-stage trial for idiopathic hypersomnia, with patients showing statistically significant improvements in excessive daytime sleepiness, indicating strong market potential for the drug.
- Safety Profile Confirmed: The Revitalyz study reaffirmed Lumryz's safety profile consistent with prior data, with no new safety signals reported, which supports its future market rollout and mitigates regulatory risks.
- Future Plans: Alkermes intends to present the trial data at an upcoming medical event and plans to submit a supplemental new drug application by the end of 2026 to seek label expansion for Lumryz in the U.S., further enhancing its competitive position.
- Market Potential: With increasing demand for treatments for idiopathic hypersomnia, Alkermes' Lumryz is poised to play a significant role in the sleep medicine sector, driving future revenue growth and market share expansion for the company.
See More
Alkermes Q1 Earnings Announcement Scheduled
- Earnings Release Date: Alkermes is set to announce its Q1 earnings on May 5 before market open, with a consensus EPS estimate of -$0.04, reflecting a significant year-over-year decline of 130.8%, indicating potential profitability challenges for the company.
- Revenue Expectations: The anticipated revenue for Q1 is $361.38 million, representing a 17.9% year-over-year increase, suggesting that despite challenges, Alkermes may still exhibit revenue growth potential, possibly reflecting stable product demand.
- Historical Performance Review: Over the past year, Alkermes has only beaten EPS estimates 25% of the time while exceeding revenue estimates 75% of the time, indicating relative stability in revenue but a need for improvement in profitability.
- Estimate Revision Trends: In the last three months, EPS estimates have seen no upward or downward revisions, while revenue estimates experienced 10 upward and 6 downward revisions, indicating market divergence in expectations for the company's future revenue.
See More
Alkermes Shares Plunge 31% After Phase 2 Study Results
- Clinical Trial Results: Alkermes reported results from its Phase 2 study of alixorexton for narcolepsy type 2, achieving dual primary endpoints; however, shares plummeted approximately 31% in after-hours trading, indicating a negative market reaction despite the trial's success.
- Primary Endpoint Achievement: The Vibrance-2 trial demonstrated improvements at week eight on the Maintenance of Wakefulness Test and Epworth Sleepiness Scale compared to placebo, with patient-reported wakefulness improvements maintained through a five-week open-label extension, suggesting the drug's potential efficacy.
- Adverse Events: No serious treatment-emergent adverse events were reported during the trial, which may bolster investor confidence in the safety profile of alixorexton, although the stock still faced downward pressure.
- Future Research Plans: Alkermes has initiated a Phase 3 program to examine once-daily and split dosing regimens of alixorexton, reflecting the company's commitment to the long-term development of the drug, despite the short-term negative market response.
See More
Alkermes Reports Positive Phase 2 Results for Alixorexton in Narcolepsy Type 2
- Clinical Trial Success: Alkermes' alixorexton achieved its primary endpoints in the Vibrance-2 phase 2 study involving 93 patients with narcolepsy type 2, demonstrating statistically significant improvements in the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) compared to placebo, indicating its substantial potential in treating narcolepsy.
- Sustained Improvement: Patient-reported enhancements in wakefulness and cognition were maintained throughout the 13-week study, with mean sleep latencies of 14 minutes and 16 minutes for the 14 mg and 18 mg doses respectively at week eight, showcasing significant clinical relevance.
- Good Safety Profile: Alixorexton exhibited favorable tolerability across all tested doses (10 mg, 14 mg, and 18 mg), with over 95% of participants completing the eight-week treatment and no serious treatment-emergent adverse events reported, underscoring its safety in clinical applications.
- Future Development Potential: Following the positive results from Vibrance-2, Alkermes has initiated a global phase 3 program to evaluate alixorexton in patients with narcolepsy type 1 and type 2, highlighting the drug's innovative potential and market prospects in the neuroscience field.
See More
Alkermes Receives Orphan Drug Designation for Alixorexton
- Orphan Drug Designation: Alkermes' alixorexton has received orphan drug designation from the FDA for idiopathic hypersomnia, marking a significant milestone in the drug development process that could expedite market access.
- European Commission Approval: The drug also received orphan drug designation from the European Commission for narcolepsy treatment, which will aid the company's expansion in the European market and enhance its international competitiveness.
- Clinical Trial Progress: Alkermes is currently enrolling patients in the phase 3 Brilliance Studies and completing the phase 2 Vibrance-3 study for alixorexton, with completion expected this year, which could lead to potential revenue growth for the company.
- Market Reaction: Alkermes shares are down 0.18% to $44.20 in pre-market trading on Nasdaq, reflecting a cautious market response to the drug development progress, which may impact investor confidence.
See More
Alkermes Receives FDA Orphan Drug Designation
- Orphan Drug Designation: The US FDA has granted orphan drug designation to Alkermes' alixorexton for idiopathic hypersomnia, highlighting the company's innovative potential in the sleep medicine sector.
- Drug Development Stage: Alixorexton is currently in phase 2 clinical trials as an oral orexin 2 receptor agonist, aimed at alleviating daytime sleepiness symptoms, which could introduce a new treatment option to the market.
- Market Demand Context: Idiopathic hypersomnia is characterized by difficulty waking up in the morning and extreme daytime sleepiness, and as awareness of sleep health increases, the successful development of this drug will meet the growing market demand.
- Strategic Company Implications: The FDA's orphan drug designation not only enhances Alkermes' reputation in the sleep medicine field but may also provide funding and market support for its future commercialization efforts, strengthening its competitive position in the CNS pharmaceutical market.
See More
Alkermes' Lumryz Achieves Key Trial Milestone for Sleep Disorder
- Trial Success: Alkermes announced that its sleep disorder therapy Lumryz met the primary goal in a late-stage trial for idiopathic hypersomnia, with patients showing statistically significant improvements in excessive daytime sleepiness, indicating strong market potential for the drug.
- Safety Profile Confirmed: The Revitalyz study reaffirmed Lumryz's safety profile consistent with prior data, with no new safety signals reported, which supports its future market rollout and mitigates regulatory risks.
- Future Plans: Alkermes intends to present the trial data at an upcoming medical event and plans to submit a supplemental new drug application by the end of 2026 to seek label expansion for Lumryz in the U.S., further enhancing its competitive position.
- Market Potential: With increasing demand for treatments for idiopathic hypersomnia, Alkermes' Lumryz is poised to play a significant role in the sleep medicine sector, driving future revenue growth and market share expansion for the company.
See More
Alkermes Q1 Earnings Announcement Scheduled
- Earnings Release Date: Alkermes is set to announce its Q1 earnings on May 5 before market open, with a consensus EPS estimate of -$0.04, reflecting a significant year-over-year decline of 130.8%, indicating potential profitability challenges for the company.
- Revenue Expectations: The anticipated revenue for Q1 is $361.38 million, representing a 17.9% year-over-year increase, suggesting that despite challenges, Alkermes may still exhibit revenue growth potential, possibly reflecting stable product demand.
- Historical Performance Review: Over the past year, Alkermes has only beaten EPS estimates 25% of the time while exceeding revenue estimates 75% of the time, indicating relative stability in revenue but a need for improvement in profitability.
- Estimate Revision Trends: In the last three months, EPS estimates have seen no upward or downward revisions, while revenue estimates experienced 10 upward and 6 downward revisions, indicating market divergence in expectations for the company's future revenue.
See More
