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Median AISRS scores fell 14 points and 19 points at 20 mg and 50 mg of ALKS 7290, respectively, after 14 days.
Treatment with ALKS 7290 was generally well tolerated, with no serious adverse effects reported.
Alkermes (ALKS - Free Report) announced positive top-line data from a phase I proof-of-concept study evaluating its novel, investigational orexin 2 receptor (OX2R) agonist, ALKS 7290, for the treatment of attention-deficit hyperactivity disorder (ADHD).
The early-stage study investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 7290 in healthy volunteers and in adults with ADHD.
More on ALKS’ Study Data on ALKS 7290 in ADHD
Data from the phase I study showed that treatment with ALKS 7290 in adults with ADHD led to dose-dependent, clinically meaningful improvements in exploratory measures of ADHD symptoms. The improvements were observed on the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression-Severity Scale (CGI-S) at day 14 of treatment.
Meanwhile, at day 14, median AISRS total scores declined by 14 points from baseline with the ALKS 7290 (20-mg) dose and 19 points with the ALKS 7290 (50-mg) dose. Improvements were also observed across the AISRS inattentive and hyperactivity/impulsivity subscales.
Treatment with ALKS 7290 was generally well tolerated across all doses in the given patient population, with no serious adverse effects being reported.
Per the company, ALKS 7290 is the first orexin 2 receptor agonist to demonstrate clinically meaningful improvements in ADHD symptoms in adults.
Enrollment is currently ongoing in a phase II study evaluating the safety and efficacy of ALKS 7290 in adults with ADHD. Data from the same is expected in 2027.
Year to date, shares of Alkermes have rallied 57.9% compared with the industry’s increase of 6.9%.
Image Source: Zacks Investment Research
ALKS' Other Pipeline Development Activities
Alkermes is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist for treating narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) in late-stage studies, as well as idiopathic hypersomnia (IH) in a mid-stage study.
In April 2026, the company initiated the phase III Brilliance studies evaluating the safety and efficacy of alixorexton versus placebo in adults with NT1 and NT2.
Alixorexton is also being evaluated in the phase II Vibrance-3 study for treating patients with IH. Top-line data from this study are expected by the end of 2026. In June 2026, the FDA granted orphan drug designation (ODD) to alixorexton for the treatment of IH.
The successful development and potential approval of alixorexton would be a significant boost for Alkermes.
ALKS Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 10.3% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
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Alkermes Posts Positive Data From Phase I ADHD Study on ALKS 7290
Key Takeaways
Alkermes (ALKS - Free Report) announced positive top-line data from a phase I proof-of-concept study evaluating its novel, investigational orexin 2 receptor (OX2R) agonist, ALKS 7290, for the treatment of attention-deficit hyperactivity disorder (ADHD).
The early-stage study investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 7290 in healthy volunteers and in adults with ADHD.
More on ALKS’ Study Data on ALKS 7290 in ADHD
Data from the phase I study showed that treatment with ALKS 7290 in adults with ADHD led to dose-dependent, clinically meaningful improvements in exploratory measures of ADHD symptoms. The improvements were observed on the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression-Severity Scale (CGI-S) at day 14 of treatment.
Meanwhile, at day 14, median AISRS total scores declined by 14 points from baseline with the ALKS 7290 (20-mg) dose and 19 points with the ALKS 7290 (50-mg) dose. Improvements were also observed across the AISRS inattentive and hyperactivity/impulsivity subscales.
Treatment with ALKS 7290 was generally well tolerated across all doses in the given patient population, with no serious adverse effects being reported.
Per the company, ALKS 7290 is the first orexin 2 receptor agonist to demonstrate clinically meaningful improvements in ADHD symptoms in adults.
Enrollment is currently ongoing in a phase II study evaluating the safety and efficacy of ALKS 7290 in adults with ADHD. Data from the same is expected in 2027.
Year to date, shares of Alkermes have rallied 57.9% compared with the industry’s increase of 6.9%.
Image Source: Zacks Investment Research
ALKS' Other Pipeline Development Activities
Alkermes is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist for treating narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) in late-stage studies, as well as idiopathic hypersomnia (IH) in a mid-stage study.
In April 2026, the company initiated the phase III Brilliance studies evaluating the safety and efficacy of alixorexton versus placebo in adults with NT1 and NT2.
Alixorexton is also being evaluated in the phase II Vibrance-3 study for treating patients with IH. Top-line data from this study are expected by the end of 2026. In June 2026, the FDA granted orphan drug designation (ODD) to alixorexton for the treatment of IH.
The successful development and potential approval of alixorexton would be a significant boost for Alkermes.
ALKS Zacks Rank & Stocks to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 10.3% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.