Highlights

  • AFT reported tentative US FDA approval for Scomara, a treatment for facial angiofibromas in tuberous sclerosis.
  • The company said all divisions recorded double-digit Revenue growth in the first half of FY27.
  • FY27 revenue is targeted at $300 million, with operating profit guidance of $28 million to $32 million.
  • Research and development spending is budgeted at $23 million to $25 million for FY27.
  • Clinical and regulatory work is continuing across injectable iron, over-the-counter and fridge-free medicine programmes.

AFT Pharmaceuticals Limited (ASX:AFP) is a multinational pharmaceutical company that develops, markets and distributes a broad portfolio of proprietary and in-licensed medicines across over-the-counter, prescription and hospital channels. Its 6 October 2026 update outlined regulatory progress for Scomara, continued growth across its operating divisions and a series of clinical and product-development milestones extending through FY27 and beyond.

Scomara Receives Tentative US Approval

AFT said Scomara has received a third US Food and Drug Administration approval, with the latest status described as tentative. The product is designed to treat facial angiofibromas associated with tuberous sclerosis. According to the company, Scomara can be stored at ambient temperature and is applied once daily.

The tentative status means the approval does not yet translate into an immediate US launch. AFT said existing market exclusivity for another product extends until early 2029, and its October update did not provide a US launch date for Scomara.

FY27 Trading and Financial Guidance

The company reported double-digit revenue growth across all divisions in the first half of FY27. It reiterated its FY27 revenue target of $300 million and operating profit guidance of $28 million to $32 million. The update did not provide detailed first-half revenue or profit figures.

AFT also budgeted $23 million to $25 million for Research and Development during FY27. The amount includes both capitalised and expensed expenditure, reflecting continued Investment across the company's product development programme.

Product Development Across Key Programmes

AFT said its pain-relief portfolio continues to expand into additional markets, while regulatory work is planned for an over-the-counter product in Australia following completion of a 240-patient clinical study designed to demonstrate therapeutic equivalence. The company said regulatory filings are planned, meaning approval has not yet been granted.

Development work is also progressing on Feramyl IV, an injectable iron product. AFT has started a 1,366-patient study across multiple regions and is targeting a first launch at the end of the 2029 calendar year. Separately, the company reported progress on a fridge-free tetanus-diphtheria booster programme following publication of a first-in-human Phase I study. AFT said its first fridge-free medicine is expected to reach the market in 2029.

Milestones and Execution Factors

Several items remain dependent on future regulatory, clinical and commercial steps. Scomara carries tentative approval, the injectable iron study is still underway, the Australian over-the-counter product requires regulatory filings, and the fridge-free Vaccine programme remains at an early development stage. AFT said its global pipeline comprises eight drugs in development, with later-stage launch timing concentrated around 2029.

Key Insights

AFT's October 2026 update combines near-term FY27 trading guidance with regulatory and clinical progress across multiple products. The company is balancing established pharmaceutical operations with ongoing research expenditure and a pipeline that includes both nearer-term filings and longer-dated development programmes. The timing of approvals, study outcomes and commercial launches will determine how these initiatives move from development into market activity.