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Axsome (AXSM) Begins Solriamfetol Binge Eating Phase III Study

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Axsome Therapeutics, Inc. (AXSM - Free Report) announced that it has initiated the phase III ENGAGE study evaluating its investigational therapy, solriamfetol, for treating adult patients with binge eating disorder (BED).

Solriamfetol is presently marketed in the United States under the brand name Sunosi for the treatment of narcolepsy.

The double-blind, placebo-controlled phase III study will evaluate the safety and efficacy of solriamfetol (150 mg or 300 mg) in adult patients with BED. The primary endpoint of the study is to see the change in binge eating episodes.

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 declined 3.3% in the year so far against the industry’s rise of 0.4%.

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We note that 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.

Last month, AXSM began dosing in the phase III PARADIGM study, which is evaluating solriamfetol for treating major depressive disorder.

The company plans to initiate a separate phase III study on Sunosi for the treatment of excessive sleepiness associated with shift work disorder shortly.

Axsome 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. Year to date, shares of ADMA have risen 44.7%.

ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have increased 23.1%.

Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.

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