Acrux (ACR: $0.012) has received feedback from the FDA on the path forward to bring the first testosterone product for women to market in the US.
The regulator will require two Phase III studies, six months long each, in women post menopause for the indication of low libido.
The area of hormone replacement therapy in women is undergoing a resurgence, as the FDA has changed its stance on these therapies based on previously inaccurate assessments of the long-term risks. Testosterone is produced by women in the ovaries and adrenal glands and falls by around 50% from 20 to 60 years of age.
With respect to testosterone replacement in women, there are multiple beneficial health aspects from testosterone treatment in women as detailed in an FDA Expert Panel Review in July last year (see Bioshares coverage in edition 995).
Testosterone is a "neural hormone, critical for mitochondria, nerve function, muscle, bone and brain function. Libido improves because dopamine and blood flow in the brain improve," according to Panel participant Dr Kelly Casperson. Feedback from women taking testosterone, according to Dr Casperson, highlighted "profound improvements in cognitive function" as well as distinctly better recovery outcomes following hip surgery.
Taking testosterone is also correlated with less dementia and recent data has shown that women can cease SSRI treatments in cases when taking testosterone supplements in combination with estrogen replacement therapy stated Dr Casperson.
Currently women are needing to obtain testosterone off-label (approved for men in the US) from compounding pharmacies at one tenth the dose required for men. This can result in variability according to Acrux CMO Dr Jolanta Airey and is not recommended by governing societies overseeing the clinical use of the therapy.
Acrux is well positioned having completed a study in 2005 in 261 women for testosterone use with its proprietary applicator. The next step for the company is to secure a partnership with a company to co-develop the therapy.
Acrux CEO John Warmbrunn said on a recent investor meeting that the company is in multiple discussions regarding the partnership and is 'very confident' of securing a deal. Warmbrunn expects a deal to include upfront and royalty payments.
The FDA has indicated that Acrux would be able to apply for a three year exclusivity period when submitting its therapy for approval.
Currently testosterone for women is approved in only four countries including Australia and excluding the US.
Acrux is capitalized at $6 million. The company had $1.7 million in cash at the end of June, with a positive cashflow from operations in FY2026 of $0.9 million. The company recorded cash receipts for the year of $5 million. The company may need to raise additional funds.
Bioshares recommendation: Speculative Buy Class C
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