- Acrux (ACR) was up as much as 54 per cent today after receiving U.S. Food and Drug Administration (FDA) approval for its testosterone topical solution
- The product will be commercialised by Dash Pharmaceuticals after a sales agreement was entered in October 2020
- Acrux’s topical solution is used for replacement therapy in males with conditions associated with a deficiency or absence of testosterone
- Current treatments for low testosterone include medication, weight loss, hormone replacement and medical procedures
- Acrux is still up a healthy 45.5 per cent and shares are trading at 24 cents
Acrux (ACR) was up as much as 54 per cent today after receiving U.S. Food and Drug Administration (FDA) approval for its testosterone topical solution.
This FDA approval means Acrux can manufacture and market the solution.
On October 12, Acrux entered a sales, marketing and distribution agreement with Dash Pharmaceuticals, which will see Dash become responsible for commercialisation of the product in the U.S.
Both companies will share the profits generated from the sales.
“FDA approval is a major milestone for Acrux and its generics strategy. It is a testament to the hard work and dedication of the product development and regulatory team,” CEO and Managing Director Michael Kotsanis said.
“We are excited to partner with Dash Pharmaceuticals to bring this product to market in the current financial year,” he added.
The testosterone solution is used to treat adult males who have little to no testosterone. Acrux’s topical treatment is used for replacement therapy in males with conditions associated with a deficiency or absence of testosterone such as primary hypogonadism (which is simply decreased testosterone production).
Current treatments for low testosterone include medication, weight loss, hormone replacement and medical procedures.
Acrux is still up a healthy 45.5 per cent and shares are trading at 24 cents at 12:18 pm AEDT.