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For years, Singapore-listed iX Biopharma has been a small biotech company with an ambitious asset: Wafermine, a fast-dissolving wafer containing the drug ketamine and is designed to treat moderate-to-severe acute pain. What has made the story far more interesting in 2026 is the involvement of the US Department of War. In February, iX received a US$41 million sole-source award to advance Wafermine. |
Now another important piece of news has come out via an iX Biopharma press release on 7 Sept pre-market.
It said that on 3 Sept, the US government published an EUA Declaration covering drugs used to treat moderate-to-severe acute pain in military casualties.
That declaration establishes the legal pathway under which the US Food and Drug Administration (FDA) can consider Wafermine for emergency military use.
Ordinarily, a new drug cannot be commercially supplied in the US until it has completed clinical trials and received full FDA approval.
Wafermine has not reached that point.
But an EUA provides a shortcut in an emergency situation.
If the FDA grants Wafermine an EUA, it could be supplied to US military personnel (likely in 1H2027) while the Phase 3 trial continues in parallel.
iX says its EUA filing is already being prepared and is targeted for completion by 4Q2026.
| Why does the US military care? |
Wafermine contains ketamine and is administered as a small wafer placed under the tongue.
iX's earlier corporate presentation compared Wafermine with opioids and Vertex Pharmaceuticals' newer non-opioid drug Journavx.
Management says Wafermine showed onset of action of around 10–20 minutes in studies, while avoiding the respiratory-depression and addiction risks associated with opioids.
Those characteristics are particularly useful on a battlefield, where injections may be inconvenient and rapid pain relief matters.
| Much larger commercial prize awaits |
iX estimates the market for moderate-to-severe acute pain could become a multibillion-dollar opportunity, and management's stated longer-term strategy is not necessarily to build a huge US salesforce itself.
| Extremely rare declaration |
| "Declarations under this military pathway are extremely rare. Based on publicly available US Federal Register records, the only previous declaration was made in July 2018, in respect of freeze-dried plasma for the treatment of uncontrolled haemorrhage in combat casualties." -- iX Biopharma press release (7 Sept) |
Instead, after successful Phase 3 trials, Wafermine could be out-licensed or sold to a major pharmaceutical company.
The latest announcement reduces the uncertainty over whether an emergency military regulatory pathway would actually exist.
The next event matters even more: the FDA's decision on Wafermine's EUA application.
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→ See also:iX BIOPHARMA: Will These Upcoming Milestones Re-rate The Stock?
