Phase 2 topline data in 2027 is the next major catalyst. Monitor enrollment updates and any early safety/efficacy signals from the ongoing study. The novel mechanism (orexin agonism) differentiates from standard stimulant therapies, which could drive significant commercial interest if Phase 2 replicates these results.
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Executive Summary
Alkermes announced positive Phase 1b proof-of-concept data for ALKS 7290, a first-in-class orexin 2 receptor agonist for ADHD, showing clinically meaningful symptom reductions on AISRS and CGI-S scales with good tolerability. A Phase 2 study is already enrolling, with data expected in 2027.
Key Facts
- ALKS 7290 is the first orexin 2 receptor agonist to demonstrate clinically meaningful improvements in ADHD symptoms in adults.
- In the Phase 1b study (n=50 adults with ADHD), median AISRS total score reductions from baseline at day 14 were 14.0 points (20 mg dose) and 19.0 points (50 mg dose).
- Median CGI-S reductions at day 14 were 1.0 (20 mg) and 2.0 (50 mg), shifting severity from markedly/moderately ill to mildly ill.
- ALKS 7290 was generally well tolerated; no serious TEAEs reported, no discontinuations in active arms, and no clinically significant findings in hepatic/renal parameters, vital signs, or ECGs.
- A Phase 2 study (NCT07755410) is enrolling ~312 participants with ADHD; first participant dosed September 2026, data expected in 2027.
- The maximum tolerated dose was not reached in healthy volunteers, supporting a wide therapeutic index.
Financial Impact
No financial figures disclosed; pipeline value inflection for ALKS 7290 in a large ADHD market (first-in-class orexin agonist).
Risk Factors
- Phase 1b study was not powered for statistical significance; Phase 2 may fail to confirm efficacy.
- ADHD market is crowded with generics and branded stimulants; differentiation and adoption are uncertain.
- Orexin agonist class safety profile is still early; long-term tolerability unknown.
- Regulatory path for a non-stimulant ADHD treatment with a novel mechanism may require additional studies.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-396065 |
| Document: alks-ex99_1.htm | 0001193125-26-396065 |
| Document: 0001193125-26-396065-index-headers.html | 0001193125-26-396065 |
| Document: 0001193125-26-396065-index.html | 0001193125-26-396065 |
| Document: 0001193125-26-396065.txt | 0001193125-26-396065 |
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Sep 21, 2026 5w ago | 8-K | $44.00 $42.97 | ▼ −2.33% | ▼ −1.43% | $44.32 (+0.73%) |
Sep 16, 2026 5w ago | 8-K | $46.07 $39.73 | ▼ −13.76% | ▼ −16.94% | $44.32 (−3.80%) |
Sep 3, 2026 7w ago | Insider Cluster | $46.10 $42.76 | ▼ −7.25% | ▼ −7.85% | $44.32 (−3.86%) |
Aug 3, 2026 12w ago | Insider Cluster | $49.67 $47.20 | ▲ +4.97% | ▲ +3.73% | $44.32 (+10.77%) |
Aug 3, 2026 12w ago | Insider Cluster | $49.67 $47.20 | ▼ −4.97% | ▼ −3.73% | $44.32 (−10.77%) |
Aug 3, 2026 12w ago | Insider Cluster | $49.67 $47.20 | ▼ −4.97% | ▼ −3.73% | $44.32 (−10.77%) |
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Jun 4, 2026 20w ago | Insider Cluster | $42.80 $55.14 | ▲ +28.83% | ▲ +26.97% | $44.32 (+3.55%) |
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