Alkermes plc ALKS
Alkermes plc (Nasdaq: ALKS) is a CNS/neurology/psychiatry drug developer. Its lead program, alixorexton, is in Phase 3 for narcolepsy type 1 and type 2. Its next catalyst on record is ALKS 7290: Phase 2 ADHD study data expected in 2027. (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: ALKS 7290 — Phase 2 ADHD study data expected in 2027. (2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| alixorexton (Brilliance Studies) | narcolepsy type 1 and type 2 | small molecule | Phase 3 |
| LUMRYZ (sodium oxybate) REVITALYZ | idiopathic hypersomnia (investigational use) | small molecule | Phase 3 |
| alixorexton (Vibrance-3) | idiopathic hypersomnia | small molecule | Phase 2 |
| Other orexin programs | — | small molecule | Pre-clinical |
Recent results and decisions
- Sep 21, 2026positive Phase 1b PoC (n=50 ADHD adults, exploratory, not powered): ALKS 7290 well tolerated; median AISRS reductions at day 14 of 14.0 (20 mg) and 19.0 (50 mg) points, CGI-S reductions of 1.0 and 2.0; no serious TEAEs.
At day 14, treatment with ALKS 7290 demonstrated median reductions from baseline in AISRS total scores of 14.0 points for the 20 mg dose and 19.0 points for the 50 mg dose.
Filing - Sep 21, 2026started Phase 2 study (~312 adults, NCT07755410) is enrolling; first participant dosed in September 2026; primary endpoint AISRS change at week 4 vs placebo.
The first participant was dosed in September 2026.
Filing - Jun 15, 2026n/a Alixorexton granted FDA orphan drug designation for idiopathic hypersomnia and European Commission orphan designation for narcolepsy.
The U.S. Food and Drug Administration (FDA) has granted ODD to alixorexton for the treatment of IH, and the European Commission has granted ODD to alixorexton for the treatment of narcolepsy.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.