ALKS 7290 — Initial data
H2 2026
Planned multi-dose phase 1b study evaluating safety, tolerability and efficacy in adult patients; data expected H2 2026Source filing
ALKS biotech catalysts & pipeline
ALKERMES PLC · Data as of 2026-09-08
Upcoming catalysts
alixorexton — Topline data
Late 2026
With our first ADHD data for ALKS 7290 expected in the coming months and topline results from our alixorexton phase 2 idiopathic hypersomnia study expected toward year-end, we are generating significant new datasets that may open new opportunities for our orexin 2 receptor portfolio,Source filing
LUMRYZ (sodium oxybate) — NDA/BLA submission
Late 2026
Based on the positive results of this phase 3 study, Alkermes plans to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) by the end of 2026.Source filing
LUMRYZ (sodium oxybate) — PDUFA
Late 2028
contingent upon final U.S. Food and Drug Administration (" FDA ") LUMRYZ ™ Approval (as defined in the form of CVR agreement to be entered into by Alkermes and the rights agent) for the treatment of idiopathic hypersomnia in adults by the end of 2028 (the " Increased Offer ").Source filing