NEW YORK - Axsome Therapeutics, Inc. (NASDAQ:AXSM) has launched a Phase 3 clinical trial named ENGAGE to evaluate the efficacy and safety of solriamfetol, a drug candidate for the treatment of binge eating disorder (BED) in adults. The ENGAGE trial, a randomized, double-blind, placebo-controlled study, will involve approximately 450 participants who will receive either solriamfetol or a placebo over a 12-week period. The primary goal of the trial is to observe changes in the frequency of binge eating episodes among patients.
The trial's first participant was screened in March 2024, marking the commencement of this critical phase of research. Solriamfetol, which functions as a dopamine and norepinephrine reuptake inhibitor and a trace amine-associated receptor 1 (TAAR1) agonist, has not yet received approval from the U.S. Food and Drug Administration (FDA) for the treatment of BED.
BED is recognized as the most prevalent eating disorder in the United States, affecting an estimated 2.8% of adults, which translates to roughly 7 million people. The disorder is characterized by episodes of excessive food consumption within a short time frame, accompanied by a sense of loss of control and significant distress, without the compensatory behaviors typically associated with bulimia nervosa.
Axsome Therapeutics is focused on the development of novel therapies for central nervous system (CNS) conditions that currently have limited treatment options. The company's commitment to improving patient care is evident in its efforts to provide innovative therapeutic solutions, as stated in the press release.
The information presented in this article is based on a press release statement from Axsome Therapeutics, Inc. and does not include any promotional content or endorsement of the company's claims. The results of the ENGAGE trial are awaited to determine the potential of solriamfetol as a treatment option for those suffering from binge eating disorder.
InvestingPro Insights
As Axsome Therapeutics (NASDAQ:AXSM) advances its Phase 3 clinical trial for solriamfetol, investors and industry watchers are closely monitoring the company's financial health and market performance. Here are some key insights from InvestingPro that may be of interest:
InvestingPro Data:
- Axsome's market capitalization stands at a robust $3.78 billion, reflecting significant investor confidence in its potential.
- Despite the company's ambitious clinical developments, analysts project a Price/Earnings (P/E) ratio of -14.99, indicating that Axsome is not expected to be profitable in the near term. This aligns with the last twelve months as of Q4 2023, where the adjusted P/E ratio further dipped to -19.17.
- A notable highlight is Axsome's gross profit margin, which reached an impressive 90.37% over the last twelve months as of Q4 2023, suggesting that the company maintains strong control over its production costs and pricing strategies.
InvestingPro Tips:
- Axsome operates with a moderate level of debt, which could be a strategic advantage in managing its financial obligations while pursuing growth opportunities.
- Despite the absence of profitability over the last twelve months, Axsome has experienced a high return over the last decade, showcasing the company's long-term growth trajectory.
For investors seeking a deeper dive into Axsome's financials and market position, there are additional 7 InvestingPro Tips available, which can be accessed through the company's dedicated page at https://www.investing.com/pro/AXSM. These insights could provide a more comprehensive understanding of Axsome's investment potential and risk profile.
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