Latest Hormone Replacement Therapy News

Acrux Limited is gearing up for Phase III clinical trials of its female testosterone therapy, backed by FDA regulatory support and a sharp increase in licensing revenue, while navigating tight cash reserves with strategic funding efforts.

Acrux Limited has secured a $0.55 million advance on its FY26 R&D Tax Incentive, providing crucial funding to accelerate development of its Hormone Replacement Therapy following FDA regulatory confirmation.

Acrux Limited reports solid revenue growth and increased cash reserves in the December quarter, driven by expanding its topical generics portfolio in the US and strategic moves into female Hormone Replacement Therapy.

Mayne Pharma reports mixed early FY26 results with strong prescription growth in Women’s Health and improved Dermatology margins, while strategic reviews and litigation loom.

Acrux Limited has sold the US registration and distribution rights for its Prilocaine 2.5% and Lidocaine 2.5% cream for US$550,000, redirecting resources towards its growing Hormone Replacement Therapy portfolio.

Acrux Ltd reported a remarkable surge in licensing revenue from its topical generics portfolio alongside a strategic pivot towards innovative drug delivery R&D at its 2025 Annual General Meeting.

The FDA's removal of the black box warning on hormone replacement therapies marks a pivotal shift for Mayne Pharma, potentially unlocking new market opportunities and reshaping women’s health treatment.