iX Biopharma (42C) said on Sep, 07 2026 that the United States Government has issued an Emergency Use Authorization (EUA) Declaration allowing its sublingual ketamine wafer, Wafermine, to be considered for emergency use in treating moderate-to-severe acute pain in military casualties.

The declaration, released on Sep, 03 2026 under section 564 of the US Federal Food, Drug, and Cosmetic Act, enables the company to advance its EUA application to the US Food and Drug Administration (FDA). Before this step, supplying Wafermine to US forces would have required full FDA approval.

In Feb, 2026 the Department of War awarded iX Biopharma a sole-source contract worth 41 million US dollars to fund the drug’s development, including Phase 3 trials and preparation of the EUA dossier. The new declaration aligns funding, development and regulatory requirements, substantially reducing program risk, the company noted.

With drafting already under way, iX Biopharma expects to file the Wafermine EUA by 4Q 2026. An FDA green light would permit the treatment’s use by US military personnel ahead of full approval, potentially allowing revenue generation while late-stage trials continue.

Chairman and chief executive officer Eddy Lee said the rare military-related declaration underscores the critical need Wafermine aims to address and that the firm’s priority is to finalise the EUA submission and expedite access for US troops.