Research update from Morgans explaining why the Testosterone...

  1. 53 Posts.
    Research update from Morgans explaining why the Testosterone market is contracting. Wouldn't be surprised if Bell revises their forecast minimally.

    What happened
    The FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. They have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. They are providing this alert while they continue to evaluate the information from these studies and other available data, and will communicate its final conclusions and recommendations when the evaluation is complete.
    The first publication that prompted FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association (JAMA) in November 2013.1 The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.
    A second observational study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy.2 The study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.
    Products such as Eli Lilly's (LLY) Axiron (Acrux's lead product); AbbVie's (ABBV) AndroGel; and Auxilium (AUXL) and GlaxoSmithKline's (GSK) Testim are the main products on the market.
    Impact to forecasts and view
    This review by the FDA will have a negative impact on sentiment towards Acrux and will probably continue to slow the market growth overall. This low growth is something we have been monitoring and in our last note we revised down our market growth assumptions from 10% to 5% from FY15 onwards. Depending on the outcome of the FDA review this growth may still be too optimistic
 
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