Alkermes Reports Positive Phase 3 Results for LUMRYZ

Alkermes ( (ALKS) ) has shared an update.

On May 12, 2026, Alkermes reported positive topline results from its phase 3 REVITALYZ trial of LUMRYZ in adults with idiopathic hypersomnia, showing statistically significant and clinically meaningful improvements in excessive daytime sleepiness and patient-reported disease severity versus placebo. The double-blind, placebo-controlled randomized withdrawal study also found that patients switched to placebo experienced marked worsening on the Epworth Sleepiness Scale, Patient Global Impression of Change, and Idiopathic Hypersomnia Severity Scale, while the safety profile remained consistent with prior LUMRYZ experience, with no new safety signals.

Alkermes plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration by the end of 2026 to seek approval of LUMRYZ for idiopathic hypersomnia, aiming to address a rare disorder with limited approved treatment options. However, under a prior settlement and license agreement, the company is barred from marketing LUMRYZ for idiopathic hypersomnia before March 1, 2028, even if approval is granted, which could delay commercial uptake but positions Alkermes to enter the market with a once-nightly therapy in a niche but underserved sleep-disorder segment.

The most recent analyst rating on (ALKS) stock is a Hold with a $43.00 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 Neutral.

Overall score reflects solid but risk-balanced fundamentals: strong gross margins and continued profitability/cash generation are tempered by sharply higher leverage and weakening recent free-cash-flow and margin trends. Technicals are supportive with price above major moving averages and positive MACD. Valuation is a drag due to the negative P/E and no dividend yield data. The latest earnings call adds support from strong product momentum and raised/affirmed outlook, while acknowledging near-term GAAP pressure and acquisition-related costs.

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

More about Alkermes

Alkermes plc is a biopharmaceutical company listed on Nasdaq that develops central nervous system therapies, including LUMRYZ, an extended-release sodium oxybate oral suspension. The company focuses on treating sleep and neurological disorders, with LUMRYZ already approved in the U.S. for excessive daytime sleepiness and cataplexy in narcolepsy patients aged seven and older.

Alkermes operates in a competitive CNS therapeutics market and seeks to expand LUMRYZ’s use into additional indications such as idiopathic hypersomnia, while navigating regulatory pathways and existing license restrictions. Its strategy centers on leveraging once-nightly dosing and established safety data to strengthen its position in sleep medicine and broaden its revenue base over time.

Average Trading Volume: 2,343,965

Technical Sentiment Signal: Buy

Current Market Cap: $5.83B

See more data about ALKS stock on TipRanks’ Stock Analysis page.