ALKS 7290

September 21, 2026: Alkermes plc (NASDAQ: ALKS) reported positive topline phase 1 proof-of-concept results for ALKS 7290, an investigational oral orexin 2 receptor agonist for adult ADHD. In the phase 1b ADHD portion (n=50), after 14 days of treatment, ALKS 7290 showed dose-dependent improvements on exploratory clinical scales: median AISRS total score reductions of 14.0 points at 20 mg and 19.0 points at 50 mg, with effects seen as early as day 6; median CGI-S reductions were 1.0 and 2.0 points, respectively, indicating shifts toward milder illness severity. The study was not designed or powered to detect statistically significant differences versus placebo.

Safety was the primary objective. ALKS 7290 was generally well tolerated in adults with ADHD and healthy volunteers (n=88); no serious treatment-emergent adverse events were reported, most adverse events were mild, and no ALKS 7290-treated participants discontinued. Common TEAEs included insomnia, pollakiuria, dizziness, change in sustained attention, micturition urgency, and constipation. No clinically significant hepatic, renal, vital sign, or ECG findings were reported.

An ongoing phase 2 trial in adults with ADHD (NCT07755410) is enrolling about 312 participants; the primary endpoint is change from baseline in AISRS total score at week 4 versus placebo, with data expected in 2027.