ALKS biotech catalysts & pipeline

ALKERMES PLC · Data as of 2026-10-25

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

ALKS 7290 — Clinical data readout

2027

— Phase 2 Study of ALKS 7290 in Adults With ADHD is Enrolling, Data Expected in 2027 —

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

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