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Axsome (AXSM) Begins Dosing in Depression Study on Sunosi
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Axsome Therapeutics, Inc. (AXSM - Free Report) announced that it has dosed the first patient in the phase III PARADIGM study evaluating its investigational therapy, solriamfetol, for treating major depressive disorder (MDD). Shares of the company were up 6% on Mar 19, following the announcement of the news.
Solriamfetol is marketed in the United States under the trade name, Sunosi, for the treatment of narcolepsy.
The double-blind and placebo-controlled phase III study will evaluate the safety and efficacy of solriamfetol (300 mg) in adult patients with MDD. The primary endpoint of the study is to see the change in the Montgomery Åsberg Depression Rating Scale.
Axsome acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. AXSM began selling Sunosi in the U.S. market in May 2022. The company also started selling the drug in certain international markets in November 2022.
Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Shares of Axsome have jumped 22.2% in the past year against the industry’s decline of 9.4%.
Image Source: Zacks Investment Research
Notably, Sunosi has become an important revenue driver for Axsome since its acquisition.
In 2023, Sunosi recorded sales worth $74.8 million, reflecting an increase of 67% on a year-over-year basis. Successful label expansion of the drug should boost sales further in the days ahead.
Apart from MDD, several other label expansion studies on the drug are currently underway.
AXSM plans to initiate separate phase III studies evaluating Sunosi for the treatment of binge eating disorder and excessive sleepiness associated with shift work disorder. Both studies are expected to begin later in the first quarter of 2024.
The company is also investigating the efficacy and safety of Sunosi in the phase III FOCUS study for the treatment of adults with attention deficit hyperactivity disorder. Top-line data from the study is expected by the second half of 2024.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. In the past year, shares of ADMA have rallied 99.7%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 70.3%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.06%.
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Axsome (AXSM) Begins Dosing in Depression Study on Sunosi
Axsome Therapeutics, Inc. (AXSM - Free Report) announced that it has dosed the first patient in the phase III PARADIGM study evaluating its investigational therapy, solriamfetol, for treating major depressive disorder (MDD). Shares of the company were up 6% on Mar 19, following the announcement of the news.
Solriamfetol is marketed in the United States under the trade name, Sunosi, for the treatment of narcolepsy.
The double-blind and placebo-controlled phase III study will evaluate the safety and efficacy of solriamfetol (300 mg) in adult patients with MDD. The primary endpoint of the study is to see the change in the Montgomery Åsberg Depression Rating Scale.
Axsome acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. AXSM began selling Sunosi in the U.S. market in May 2022. The company also started selling the drug in certain international markets in November 2022.
Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Shares of Axsome have jumped 22.2% in the past year against the industry’s decline of 9.4%.
Image Source: Zacks Investment Research
Notably, Sunosi has become an important revenue driver for Axsome since its acquisition.
In 2023, Sunosi recorded sales worth $74.8 million, reflecting an increase of 67% on a year-over-year basis. Successful label expansion of the drug should boost sales further in the days ahead.
Apart from MDD, several other label expansion studies on the drug are currently underway.
AXSM plans to initiate separate phase III studies evaluating Sunosi for the treatment of binge eating disorder and excessive sleepiness associated with shift work disorder. Both studies are expected to begin later in the first quarter of 2024.
The company is also investigating the efficacy and safety of Sunosi in the phase III FOCUS study for the treatment of adults with attention deficit hyperactivity disorder. Top-line data from the study is expected by the second half of 2024.
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - 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.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. In the past year, shares of ADMA have rallied 99.7%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 70.3%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.06%.