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AXSM Stock Down Despite ADHD Study Meeting Primary Endpoint
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Axsome Therapeutics (AXSM - Free Report) announced that the phase III FOCUS study, which evaluated solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD), has met its primary and key secondary endpoints.
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. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz had received approval for Sunosi as a treatment for narcolepsy in 2019.
Year to date, shares of Axsome have rallied 42.2% compared with the industry’s increase of 6%.
Image Source: Zacks Investment Research
Data From AXSM's FOCUS Study on Solriamfetol
The double-blind, placebo-controlled phase III FOCUS study evaluated solriamfetol versus placebo in adults with ADHD. Patients were randomized to receive once daily solriamfetol (150 mg, 300 mg) or placebo for six weeks.
Data from the study showed that treatment with solriamfetol (150 mg) led to a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score — the study’s primary endpoint — versus placebo at week six. Treatment with solriamfetol (150 mg) demonstrated a mean reduction from baseline of 17.7 points as compared with 14.3 points for placebo.
The overall improvement achieved with solriamfetol reflected a 45% mean reduction from baseline in ADHD symptoms at week six. Moreover, the improvements in the AISRS total score were greater with solriamfetol compared to placebo as early as week one.
The FOCUS study also met its key secondary endpoint by demonstrating a statistically significant reduction in overall ADHD disease severity versus placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for ADHD at week six.
Despite the FOCUS study showing that solriamfetol was able to reduce mean ADHD symptom burden by almost 50%, shares of Axsome were down 6.8% on March 25 following the announcement of the news.
The stock price decline could be because of the fact that the higher dose of solriamfetol (300 mg) could not achieve the primary and secondary endpoints with statistical significance versus placebo.
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).
Top-line data from the PARADIGM study, evaluating Sunosi for treating MDD, is expected to be released shortly.
Meanwhile, top-line data from the ENGAGE study and the SUSTAIN study, evaluating Sunosi for treating BED and SWD in adults, respectively, are expected in 2026.
Sunosi — A Key Top-line Driver for AXSM
Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $94.3 million in 2024, reflecting an increase of 26% on a year-over-year basis.
Earlier this month, Axsome entered into a settlement agreement with Hikma Pharmaceuticals related to patents for Sunosi (solriamfetol). Per the settlement terms, Axsome will grant Hikma a license to sell a generic version of Sunosi in the United States, subject to approval from the FDA and other customary conditions, on or after March 1, 2040. However, if pediatric exclusivity is granted to Sunosi, Hikma can launch the generic version on or after Sept. 1, 2040.
The patent litigation settlement helps Axsome protect Sunosi sales from generic erosion in the United States.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.53 to $7.87 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.76 to $8.27. Year to date, shares of GILD have increased 16.8%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.50 to $7.06 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $11. Year to date, shares of KRYS have rallied 22.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.
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AXSM Stock Down Despite ADHD Study Meeting Primary Endpoint
Axsome Therapeutics (AXSM - Free Report) announced that the phase III FOCUS study, which evaluated solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD), has met its primary and key secondary endpoints.
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. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz had received approval for Sunosi as a treatment for narcolepsy in 2019.
Year to date, shares of Axsome have rallied 42.2% compared with the industry’s increase of 6%.
Image Source: Zacks Investment Research
Data From AXSM's FOCUS Study on Solriamfetol
The double-blind, placebo-controlled phase III FOCUS study evaluated solriamfetol versus placebo in adults with ADHD. Patients were randomized to receive once daily solriamfetol (150 mg, 300 mg) or placebo for six weeks.
Data from the study showed that treatment with solriamfetol (150 mg) led to a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score — the study’s primary endpoint — versus placebo at week six. Treatment with solriamfetol (150 mg) demonstrated a mean reduction from baseline of 17.7 points as compared with 14.3 points for placebo.
The overall improvement achieved with solriamfetol reflected a 45% mean reduction from baseline in ADHD symptoms at week six. Moreover, the improvements in the AISRS total score were greater with solriamfetol compared to placebo as early as week one.
The FOCUS study also met its key secondary endpoint by demonstrating a statistically significant reduction in overall ADHD disease severity versus placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for ADHD at week six.
Despite the FOCUS study showing that solriamfetol was able to reduce mean ADHD symptom burden by almost 50%, shares of Axsome were down 6.8% on March 25 following the announcement of the news.
The stock price decline could be because of the fact that the higher dose of solriamfetol (300 mg) could not achieve the primary and secondary endpoints with statistical significance versus placebo.
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).
Top-line data from the PARADIGM study, evaluating Sunosi for treating MDD, is expected to be released shortly.
Meanwhile, top-line data from the ENGAGE study and the SUSTAIN study, evaluating Sunosi for treating BED and SWD in adults, respectively, are expected in 2026.
Sunosi — A Key Top-line Driver for AXSM
Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $94.3 million in 2024, reflecting an increase of 26% on a year-over-year basis.
Earlier this month, Axsome entered into a settlement agreement with Hikma Pharmaceuticals related to patents for Sunosi (solriamfetol). Per the settlement terms, Axsome will grant Hikma a license to sell a generic version of Sunosi in the United States, subject to approval from the FDA and other customary conditions, on or after March 1, 2040. However, if pediatric exclusivity is granted to Sunosi, Hikma can launch the generic version on or after Sept. 1, 2040.
The patent litigation settlement helps Axsome protect Sunosi sales from generic erosion in the United States.
AXSM's Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. (GILD - Free Report) and Krystal Biotech, Inc. (KRYS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.53 to $7.87 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.76 to $8.27. Year to date, shares of GILD have increased 16.8%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.50 to $7.06 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $11. Year to date, shares of KRYS have rallied 22.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.