Shares of Acrux Limited (ASX: ACR) have crashed more than 10% today with investors growing increasingly uncertain about the future of its testosterone treatment product, Axiron.
So What: In an update to the market this morning, Acrux confirmed that the US Food and Drug Administration (FDA) had released a statement regarding the use of Testosterone Replacement Therapy. The statement expressed concerns over the possible increased risk of heart attack and stroke associated with the treatments.
As a result of the FDA's review, all testosterone treatments in the US will require clearer labelling outlining the possible risks, while further testing must be undertaken to clarify the product's safety. The labelling will also need to clarify the approved uses of the medication, which should only be used when low testosterone levels are caused by certain medical conditions.
The shares were trading at 91.7 cents late in the session, down 10.1% for the day.
Now What: According to the Fairfax press, Acrux said the new testing could take years to complete which will only increase the market's uncertainty over the company's potential, especially after the company's somewhat uninspiring half-year report late last month.
