Acrux gains FDA clarity for female testosterone spray trials

FDA pathway advances Acrux’s lead clinical programme

Acrux Limited (ASX:ACR) has gained a more defined regulatory route for its Female Testosterone metered-dose transdermal spray, with the US Food and Drug Administration confirming the Phase III pathway for postmenopausal women with Hypoactive Sexual Desire Disorder. The agency has also indicated that Acrux may apply for three years of data exclusivity when it submits for approval, provided the new formulation and supporting clinical studies meet the relevant requirements.

The guidance does not amount to approval, and the pivotal trials have not yet started. Acrux is finalising protocols for two 24-week Phase III efficacy studies, alongside a further 28 weeks of data intended to inform chronic-treatment safety. The company said the FDA considered the spray a new product formulation and viewed a chronic dermal and systemic safety study as consistent with its guidelines.

The latest update formalises the regulatory picture outlined in Acrux’s FDA Phase III pathway coverage, which reported that the agency had identified the evidence package required for the programme. Acrux said the clearer requirements had moved co-development discussions with potential partners to the next stage, although no partnership has been announced in this filing.

Tax rebate turns quarterly cash flow positive

Acrux reported net cash from operating activities of $226,000 for the September quarter, but the headline improvement came mainly from a $1.977 million FY26 Research and Development Tax Incentive rebate. The company also generated $463,000 in customer receipts, including $463,000 of profit-share and royalty income from its generic portfolio and laboratory fee-for-service work.

That cash benefit was partly offset by $1.527 million of operating expenditure and the repayment of $950,000 in earlier R&D rebate advances, plus $113,000 of interest. Acrux finished the quarter with $1.396 million in cash and cash equivalents, while its available unused financing facilities stood at $399,000. The company said it is working on several transactions to secure capital for the Female Testosterone MDTS development programme.

Cost base reset leaves funding as the next test

The company is shrinking around its lead asset. Six redundancies completed in July reduced headcount to 19, with Acrux saying the remaining workforce is being aligned to the Female Testosterone MDTS project after activities connected with the generic portfolio and external fee-for-service revenue ceased. Staff costs for the quarter were $1.344 million, including $329,000 associated with the redundancies.

The FDA clarity is a meaningful development for a programme that still needs financing, trial execution and eventual regulatory submission. Acrux’s earlier financial update described its pivot towards the therapy and efforts to secure co-development support; the current quarter makes the immediate capital requirement more explicit. The next material markers are likely to be final Phase III protocols, a funding or partnering transaction and evidence that the company can move from regulatory planning into trial commencement.