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How FDA Breakthrough Therapy Status for Alixorexton Will Impact Alkermes (ALKS) Investors

Simply Wall St · 2d ago
  • Alkermes plc recently reported that the U.S. FDA granted Breakthrough Therapy designation to its investigational oral orexin 2 receptor agonist alixorexton for narcolepsy type 1, following phase 1 and phase 2 data including the large Vibrance-1 study showing statistically significant, dose-dependent improvements in wakefulness versus placebo.
  • This designation, which is reserved for treatments that may offer substantial improvement over existing options for serious conditions, positions alixorexton as a potentially differentiated entrant in sleep-wake disorders, adding a new regulatory milestone to Alkermes’ orexin-focused pipeline.
  • We’ll now examine how Breakthrough Therapy status for alixorexton could reshape Alkermes’ orexin opportunity and its broader investment narrative.

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Alkermes Investment Narrative Recap

To own Alkermes, you need to believe its orexin franchise can become a meaningful, durable growth pillar alongside Vivitrol, Aristada and Lybalvi, while funding higher R&D without eroding profitability. The FDA’s Breakthrough Therapy designation for alixorexton strengthens the near term catalyst around the planned phase 3 program, but it does not remove the key risk that rising development spend on orexin agonists may not be matched by successful late stage outcomes.

The most relevant recent announcement alongside Breakthrough status is the positive Vibrance 2 phase 2 data in narcolepsy type 2, which reinforced the broader orexin thesis ahead of phase 3. Together with solid 2025 quarterly results and continued profitability, these updates keep investor attention focused on whether Alkermes can convert its orexin pipeline into a new revenue stream that justifies higher long term R&D intensity.

Yet even with Breakthrough status, investors should be aware of the risk that additional regulatory requirements or safety findings could still...

Read the full narrative on Alkermes (it's free!)

Alkermes' narrative projects $1.4 billion revenue and $169.0 million earnings by 2028. This implies revenue declining by 1.3% per year and an earnings decrease of $179.1 million from $348.1 million today.

Uncover how Alkermes' forecasts yield a $43.81 fair value, a 49% upside to its current price.

Exploring Other Perspectives

ALKS 1-Year Stock Price Chart
ALKS 1-Year Stock Price Chart

Four members of the Simply Wall St Community value Alkermes between US$43.81 and US$103.24, underlining how far opinions can spread. Set against this, the orexin program’s higher R&D burden and clinical uncertainty could materially influence how those expectations ultimately play out.

Explore 4 other fair value estimates on Alkermes - why the stock might be worth over 3x more than the current price!

Build Your Own Alkermes Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

  • A great starting point for your Alkermes research is our analysis highlighting 3 key rewards that could impact your investment decision.
  • Our free Alkermes research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Alkermes' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.