Axsome (AXSM) Doses First Patient in Late-Stage ADHD Study
Axsome AXSM announced that the first patient has been dosed in the late-stage, label expansion study of solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) in adults.
Solriamfetol is an investigational therapy that acts as a reuptake inhibitor of dopamine and norepinephrine. It is commercialized under the brand name Sunosi, which is used for treating excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea.
In May 2022, Axsome acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ.
In 2019, JAZZ received approval for Sunosi as a treatment for narcolepsy. JAZZ is entitled to receive high single-digit royalty on U.S. net sales of the drug.
In the first quarter of 2023, Sunosi's net product revenues amounted to $12.9 million.
The phase III FOCUS study aims to assess the effectiveness and safety of solriamfetol in adults with ADHD. It will be a random, double-blind, placebo-controlled study, wherein patients will be dosed at 150 mg or 300 mg of solriamfetol, or a placebo, for six weeks. The primary endpoint of the study is to observe the change in the adult ADHD investigator symptom report scale.
Axsome’s shares nosedived 5.7% year to date compared with the industry’s 12% decline.
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ADHD is a chronic neurobiological and developmental disorder. It is estimated that 11.4 million adults in the United States have been diagnosed with the condition. The economic burden of adult ADHD in the country has been estimated to reach an annual societal cost of $122.8 billion.
Axsome’s other commercial products include Auvelity (AXS-05), indicated for the treatment of major depressive disorder. The drug was launched in October 2022. In the first quarter of 2023, Auvelity recorded its first full-quarter sales of $15.7 million.
Several expansion studies on AXS-05 are currently underway for the treatment of other central nervous system disorders.
Axsome Therapeutics, Inc. Price and Consensus
Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Novartis NVS and Akero Therapeutics AKRO, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Novartis’ 2023 earnings has gone up from $6.57 per share to $6.72 in the past 90 days. Shares of Novartis have risen 4.4% year to date.
NVS’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 5.15%.
The consensus estimate for Akero Therapeutics has narrowed from a loss of $2.92 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 20.3% year to date.
AKRO’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
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