Alkermes reports positive phase 2 results for narcolepsy drug

Published 08/09/2025, 08:22
Alkermes reports positive phase 2 results for narcolepsy drug

DUBLIN - Alkermes plc (NASDAQ:ALKS), a $4.94 billion biopharmaceutical company with robust financials and an impressive 85% gross profit margin, announced Monday that its investigational narcolepsy treatment alixorexton demonstrated significant improvements in wakefulness, cognition and fatigue in patients with narcolepsy type 1 (NT1) during a phase 2 clinical trial. According to InvestingPro data, the company maintains strong financial health with more cash than debt on its balance sheet.

The six-week Vibrance-1 study involving 92 patients showed that once-daily alixorexton met its primary endpoint across all tested doses (4 mg, 6 mg and 8 mg), with statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test compared to placebo.

Patients receiving alixorexton achieved normative wakefulness with mean sleep latency of approximately 24-28 minutes across the different doses, compared to baseline measurements of approximately 3 minutes. The drug also demonstrated improvements in the Epworth Sleepiness Scale, with scores maintained in the normal range for all doses throughout the treatment period.

On cataplexy rates, the 6 mg dose showed statistically significant improvement, with more than 40% of patients at the 6 mg and 8 mg doses achieving complete elimination of cataplexy during the final week of the study.

The oral selective orexin 2 receptor agonist was generally well tolerated, with no serious treatment-emergent adverse events reported. Common side effects included increased urination frequency, insomnia, excessive salivation, urinary urgency and blurred vision, with most events being mild to moderate in severity.

"These data underscore alixorexton’s potential to be an important new treatment option for narcolepsy type 1 and to reduce the broader disease burden of this complex neurological disorder," said Giuseppe Plazzi, Director of the Narcolepsy Center at the IRCCS of the Neurological Sciences of Bologna, in a statement included in the company’s press release. Wall Street appears optimistic about Alkermes’ prospects, with analysts maintaining a bullish consensus recommendation. Discover more insights about ALKS and 1,400+ other stocks through comprehensive Pro Research Reports available on InvestingPro.

Alkermes plans to initiate a global phase 3 program for alixorexton in the first quarter of 2026. The company is also evaluating the drug in separate phase 2 studies for narcolepsy type 2 and idiopathic hypersomnia. With the next earnings announcement scheduled for October 22, 2025, investors can access detailed financial analysis and 10+ additional ProTips through InvestingPro, which currently indicates the stock may be undervalued based on its Fair Value assessment.

In other recent news, Alkermes Plc announced its financial results for the second quarter of 2025, reporting earnings that exceeded analysts’ expectations. The company achieved an earnings per share (EPS) of $0.52, surpassing the projected $0.36. Additionally, Alkermes’ revenue reached $390.7 million, well above the forecasted $347.16 million. These financial achievements highlight the company’s strong performance in the recent quarter. The earnings results have been a focal point for investors, given the substantial outperformance in both EPS and revenue. The positive financial outcome has drawn attention from various analyst firms. While specific analyst upgrades or downgrades were not mentioned, the better-than-expected earnings could potentially influence future analyst ratings. These developments underscore Alkermes’ financial health and operational efficiency during the second quarter of 2025.

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