Alkermes Receives FDA Breakthrough Therapy Designation for Alixorexton in Treating Narcolepsy Type 1
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 06 2026
0mins
Source: Newsfilter
- FDA Breakthrough Designation: Alkermes announced that its novel drug alixorexton has received Breakthrough Therapy designation from the FDA based on positive results from the Vibrance-1 phase 2 trial involving 92 patients, indicating significant potential market value in treating narcolepsy type 1.
- Successful Clinical Trials: In the Vibrance-1 study, alixorexton met its primary endpoint across all tested doses, demonstrating statistically significant improvements in wakefulness compared to placebo, highlighting its potential to enhance patients' quality of life.
- Future Development Plans: Alkermes plans to initiate a global phase 3 clinical program for alixorexton in the first quarter of 2026, aiming to further validate its efficacy and expedite the path to market, which is expected to create new revenue streams for the company.
- Market Demand Opportunity: The Breakthrough Therapy designation underscores alixorexton's importance in addressing the unmet medical needs of narcolepsy patients, and if approved, it could set a new standard of care in the field, enhancing the company's competitiveness in neuroscience.
Discover Tomorrow's Bullish Stocks Today
Receive free daily stock recommendations and professional analysis to optimize your portfolio's potential.
Sign up now to unlock expert insights and stay one step ahead of the market trends.
Analyst Views on ALKS
Wall Street analysts forecast ALKS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ALKS is 46.17 USD with a low forecast of 37.00 USD and a high forecast of 58.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
14 Analyst Rating
11 Buy
3 Hold
0 Sell
Strong Buy
Current: 33.900
Low
37.00
Averages
46.17
High
58.00
Current: 33.900
Low
37.00
Averages
46.17
High
58.00
About ALKS
Alkermes plc is Ireland-based 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 and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders. It focuses on commercial products, such as LYBALVI, ARISTADA/ARISTADA INITIO and VIVITROL, and advancing the development of pipeline programs focused on neurological disorders. LYBALVI is a once-daily, oral atypical antipsychotic drug for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. ARISTADA is an extended-release intramuscular injectable suspension for the treatment of schizophrenia. It has a manufacturing facility in Wilmington, Ohio.
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.
Goldman Sachs Downgrades Super Micro Computer to Sell with $26 Price Target
- Rating Downgrade: Goldman Sachs analyst Katherine Murphy initiated coverage of Super Micro Computer (NASDAQ:SMCI) on January 13 with a Sell rating and a price target of $26, reflecting a pessimistic outlook that may lead to decreased investor confidence.
- Merger Approval: Shareholders of Huntington Bancshares (NASDAQ:HBAN) and Cadence Bank approved their pending merger on January 6, which is expected to enhance market competitiveness and resource integration, driving future business growth.
- Analyst Support: Multiple analysts initiated coverage of Medline Inc. (NASDAQ:MDLN) on January 12 with bullish ratings, indicating a positive market sentiment towards the company's prospects that could attract more investor interest.
- Market Reaction: Super Micro Computer's shares jumped 11.1% to settle at $32.66 on Friday, indicating mixed market reactions to Jim Cramer's sell recommendation, which may influence subsequent investment decisions.
Continue Reading
ImmunityBio (IBRX) Shares Surge 39.8% on Positive QUILT-106 Study Data
- Efficacy Data Update: ImmunityBio's updated efficacy and safety data from the QUILT-106 clinical study show that patients receiving CD19 CAR-NK therapy achieved 100% disease control over 15 months, significantly enhancing the company's competitive position in the Waldenström non-Hodgkin lymphoma space.
- Innovative Treatment Regimen: The study's use of CD19 CAR-NK cells combined with Roche's Rituxan allows outpatient treatment without chemotherapy, highlighting the therapy's strategic importance in terms of patient-friendliness and scalability.
- Strong Market Reaction: ImmunityBio's stock surged 106% over the past six months, significantly outpacing the industry's 22.1% growth, reflecting strong market confidence in its new therapy and positive investor sentiment.
- Future Development Plans: ImmunityBio aims to submit a biologics license application to the FDA by the end of 2026, with full enrollment in the QUILT-2.005 study expected to further bolster the company's market position in treating BCG-unresponsive bladder cancer.
Continue Reading