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Alkermes Gains FDA Breakthrough Status for Narcolepsy Drug

Story Highlights
  • Alkermes received FDA Breakthrough Therapy status for alixorexton in narcolepsy type 1.
  • Positive phase 2 data and tolerability support a global phase 3 program, bolstering Alkermes’ position in sleep disorders.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Alkermes Gains FDA Breakthrough Status for Narcolepsy Drug

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The latest announcement is out from Alkermes ( (ALKS) ).

On January 6, 2026, Alkermes announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to alixorexton, its oral, selective orexin 2 receptor agonist, for the treatment of narcolepsy type 1, following encouraging phase 1 and phase 2 data, including positive results from the 92-patient Vibrance-1 study. In that phase 2 trial, alixorexton met its primary endpoint at all tested doses, showing statistically significant, clinically meaningful and dose-dependent improvements in wakefulness versus placebo on the Maintenance of Wakefulness Test, and was generally well tolerated, prompting Alkermes to plan initiation of a global phase 3 program for narcolepsy in the first quarter of 2026, a move that could strengthen its position in sleep-disorder therapeutics and potentially establish alixorexton as a new standard of care in narcolepsy type 1 if late-stage data and regulatory review are favorable.

The most recent analyst rating on (ALKS) stock is a Buy with a $37.00 price target. To see the full list of analyst forecasts on Alkermes stock, see the ALKS Stock Forecast page.

Spark’s Take on ALKS Stock

According to Spark, TipRanks’ AI Analyst, ALKS is a Outperform.

Alkermes’ strong financial performance and strategic acquisitions are the primary drivers of its high score. The company’s robust profitability, low leverage, and positive earnings call sentiment further bolster its position. Technical analysis presents some caution, but overall, Alkermes is well-positioned for growth in the biotechnology sector.

To see Spark’s full report on ALKS stock, click here.

More about Alkermes

Alkermes plc is a global biopharmaceutical company focused on neuroscience, with proprietary commercial drugs for alcohol and opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates for neurological conditions such as narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, the company operates a corporate office and R&D center in Massachusetts and a manufacturing facility in Ohio, positioning it as a mid-cap growth and value player in the central nervous system therapeutics market.

Average Trading Volume: 2,264,087

Technical Sentiment Signal: Hold

Current Market Cap: $4.62B

Find detailed analytics on ALKS stock on TipRanks’ Stock Analysis page.

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