Psyence BioMed unit signs ibogaine manufacturing deal in Texas

Psyence Biomedical Ltd. (Nasdaq: PBM) announced that its wholly-owned Texas subsidiary, Texas Ibogaine Research Corporation (TIRC), has entered into a manufacturing services agreement with Benuvia Operations, LLC to produce pharmaceutical-grade ibogaine active pharmaceutical ingredient (API) under current Good Manufacturing Practice standards.

Benuvia operates an approximately 83,000-square-foot pharmaceutical manufacturing facility in Round Rock, Texas, registered with the U.S. Drug Enforcement Administration (DEA). According to Benuvia, the company currently holds approximately half of the U.S. aggregate production quota for ibogaine. Benuvia is advancing applications with the DEA for the import permit and procurement quota required for the planned production.

The manufacturing agreement builds on a previously announced binding term sheet between TIRC and Psyence Labs Ltd. (PsyLabs), under which TIRC would receive an exclusive U.S. license, supply and wholesale distribution arrangement for PsyLabs' pharmaceutical-grade ibogaine. A definitive agreement between the parties is to be concluded on or before November 30, 2026.

Psyence BioMed holds an ownership interest in PsyLabs, which is also a significant shareholder of Psyence BioMed.

"Benuvia brings a DEA-registered U.S. facility with the quota, systems and track record required to manufacture controlled substances to pharmaceutical standards," said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed and TIRC.

The company stated that the timing and scale of any U.S. ibogaine production will be governed primarily by applicable DEA quotas, controlled-substance import requirements and other regulatory authorizations. No clinical trial has been commenced and no regulatory application has been filed or accepted. The FDA has not approved ibogaine for therapeutic use.

You May Also Be Interested In

• Coca-Cola picks Omnicom for North America, keeps WPP globally
• Black Hills Corp. plans to rename as Bright Horizon Energy after merger
• Rambus invests in ChipAgents, adopts its AI chip design platform