Alkermes Receives FDA Breakthrough Therapy Designation for Alixorexton, Potentially Accelerating Development
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 19 2026
0mins
Source: Yahoo Finance
- FDA Designation Impact: Alkermes' alixorexton has received Breakthrough Therapy designation from the FDA based on positive data from the Vibrance-1 study, which could enhance the company's competitive position in the sleep disorder market by improving existing narcolepsy treatments.
- R&D Outlook: This designation not only serves as a near-term catalyst for Alkermes' orexin agonist portfolio but may also accelerate development across multiple sleep disorders, bolstering investor confidence in the company's potential for revenue diversification.
- Financial Projections: Alkermes projects $1.4 billion in revenue and $169 million in earnings by 2028, indicating a 1.3% annual revenue decline; however, the Breakthrough Therapy recognition could reshape market perceptions of its long-term profitability.
- Investor Focus: With the FDA's endorsement, investors should closely monitor the significant impact of clinical and regulatory outcomes on Alkermes' long-term earnings, which could materially influence its stock price and market valuation.
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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.
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