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Axsome Begins Phase III Study on Solriamfetol for ADHD in Children
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Key Takeaways
Axsome dosed the first patient in the phase III FOCUS-2 study of solriamfetol for children with ADHD.
The placebo-controlled study will evaluate solriamfetol's safety and efficacy in children with ADHD.
Axsome is also running separate phase III ADHD studies in adolescents and adults for solriamfetol.
Axsome Therapeutics (AXSM - Free Report) announced that it has dosed the first patient in the phase III FOCUS-2 study evaluating solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged six to less than 12 years.
The randomized, double-blind, placebo-controlled phase III FOCUS-2 study is designed to assess the safety and efficacy of solriamfetol in children aged six to less than 12 years with ADHD. The primary endpoint of the study is to see the change from baseline to week six in the ADHD Rating Scale (ADHD-RS-5) total score.
Last month, the company initiated the phase III FOCUS-3 study evaluating solriamfetol for treating ADHD in adolescents aged 12 to less than 18 years.
Axsome is also conducting the phase III FOCUS study, which is evaluating solriamfetol for treating ADHD in adults.
AXSM’s Price Performance
Year to date, shares of Axsome have rallied 36.8% compared with the industry’s increase of 6.8%.
Image Source: Zacks Investment Research
Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.
Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022.
Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States.
AXSM's Other Ongoing Studies on Solriamfetol
Besides ADHD, Axsome is evaluating solriamfetol in separate phase III studies for treating major depressive disorder (MDD), binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).
In February 2026, Axsome initiated the phase III CLARITY study evaluating solriamfetol for the treatment of MDD with excessive daytime sleepiness symptoms. The primary endpoint of the study will be to check the time from randomization to relapse of depressive symptoms.
The phase III ENGAGE study is evaluating solriamfetol in BED, with top-line data from the same expected in the second half of 2026. The phase III SUSTAIN study is evaluating solriamfetol in SWD in adults, with top-line data expected to be announced in 2027.
Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $33.9 million in the first quarter of 2026, reflecting an increase of 34% on a year-over-year basis.
Successful development and potential approval for Sunosi in additional indications are likely to boost sales further in future quarters.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 63.1% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $3.02, while estimates for 2027 have increased from $2.91 to $4.92 during the same time. LQDA shares have surged 135.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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Axsome Begins Phase III Study on Solriamfetol for ADHD in Children
Key Takeaways
Axsome Therapeutics (AXSM - Free Report) announced that it has dosed the first patient in the phase III FOCUS-2 study evaluating solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged six to less than 12 years.
The randomized, double-blind, placebo-controlled phase III FOCUS-2 study is designed to assess the safety and efficacy of solriamfetol in children aged six to less than 12 years with ADHD. The primary endpoint of the study is to see the change from baseline to week six in the ADHD Rating Scale (ADHD-RS-5) total score.
Last month, the company initiated the phase III FOCUS-3 study evaluating solriamfetol for treating ADHD in adolescents aged 12 to less than 18 years.
Axsome is also conducting the phase III FOCUS study, which is evaluating solriamfetol for treating ADHD in adults.
AXSM’s Price Performance
Year to date, shares of Axsome have rallied 36.8% compared with the industry’s increase of 6.8%.
Image Source: Zacks Investment Research
Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.
Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022.
Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States.
AXSM's Other Ongoing Studies on Solriamfetol
Besides ADHD, Axsome is evaluating solriamfetol in separate phase III studies for treating major depressive disorder (MDD), binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).
In February 2026, Axsome initiated the phase III CLARITY study evaluating solriamfetol for the treatment of MDD with excessive daytime sleepiness symptoms. The primary endpoint of the study will be to check the time from randomization to relapse of depressive symptoms.
The phase III ENGAGE study is evaluating solriamfetol in BED, with top-line data from the same expected in the second half of 2026. The phase III SUSTAIN study is evaluating solriamfetol in SWD in adults, with top-line data expected to be announced in 2027.
Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $33.9 million in the first quarter of 2026, reflecting an increase of 34% on a year-over-year basis.
Successful development and potential approval for Sunosi in additional indications are likely to boost sales further in future quarters.
AXSM Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 63.1% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $3.02, while estimates for 2027 have increased from $2.91 to $4.92 during the same time. LQDA shares have surged 135.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.