iX Biopharma replies SGX queries on partner’s licence, says US$41m Pentagon ketamine wafer deal unaffected
Its stock rose more than 1% on Nov 4 after responding to SGX, and has more than tripled year-to-date.
iX Biopharma, a Singapore-listed company, has clarified that a potential US manufacturing partner, Orion Specialty Labs, has not obtained the necessary Nevada state licence for its facility. This clarification comes following Singapore Exchange (SGX) queries regarding the status of the partnership, which was announced in November 2025.
The partnership aims to manufacture and sell iX Biopharma's proprietary sublingual wafer products, known as Wafermine, for battlefield use. SGX's inquiry arose after an Oct 20 investigative report highlighted that Orion had not secured the required state licence, which had been postponed twice. iX Biopharma maintains that the licensing timeline is aligned with their plans, emphasizing that "regulatory licenses" in their announcement referred to Orion's registration with the US Food and Drug Administration (FDA) as a 503B outsourcing facility, which prepares compounded medicines for healthcare providers.
The Nevada state licence, a separate requirement, is expected to follow the joint venture's finalisation and equipment installation. The company also explained that "operationally ready infrastructure" refers to Orion's facility being equipped to handle its manufacturing operations, saving time and resources for iX Biopharma. The Wafermine ketamine wafer is a product developed for military use, and its development is independent of the joint venture with Orion.
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