Alkermes plc.

Alkermes plc announced that its investigational drug, alixorexton, has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia and the European Commission for the treatment of narcolepsy. Alixorexton is an oral, selective orexin 2 receptor agonist currently in development for narcolepsy types 1 and 2, and idiopathic hypersomnia. This designation provides incentives for the development of treatments for rare diseases and offers potential market exclusivity if the drug is approved.

Alkermes plc shareholders approved amendments to the 2018 Stock Option and Incentive Plan, increasing the number of ordinary shares authorized for issuance by 5,900,000. At the Annual Meeting, shareholders also elected nine directors, approved executive officer compensation in a non-binding advisory vote, and ratified PricewaterhouseCoopers LLP as the independent auditor. Additionally, they renewed the Board's authority to allot and issue shares and to disapply statutory pre-emption rights under Irish law.

Alkermes plc announced positive topline results from the REVITALYZSM Phase 3 study evaluating LUMRYZ (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH). The study met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in excessive daytime sleepiness and patient-reported disease severity compared to placebo. The safety profile was consistent with known LUMRYZ data, and Alkermes plans to file an sNDA with the FDA by the end of 2026, though marketing for IH is restricted until March 2028.

Alkermes plc completed the acquisition of Avadel Pharmaceuticals plc for $2.31 billion on February 12, 2026, significantly impacting its financial position. The company reported a net loss of $(66.5) million for Q1 2026, a decline from a net income of $22.5 million in Q1 2025, primarily due to acquisition-related expenses and increased interest costs. Despite the loss, total revenues grew 28.2% to $392.9 million, driven by a 38.3% increase in product sales. The acquisition led to a substantial increase in total assets to $4.26 billion and total liabilities to $2.51 billion, including $1.48 billion in long-term debt.