Psyence BioMed Adds DEA-Registered Benuvia for U.S. Ibogaine Manufacturing
PBM has more than doubled off its 52-week low of $1.92.
Summary
Psyence BioMed's TIRC subsidiary partnered with DEA-registered Benuvia Operations to establish U.S. manufacturing of pharmaceutical-grade ibogaine, building on the prior PsyLabs supply term sheet.
Key Events · M&A and Partnerships · PBM
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Benuvia Manufacturing Partnership Signed
TIRC entered a manufacturing services agreement with Benuvia Operations, a DEA-registered controlled-substance manufacturer in Round Rock, Texas, for planned U.S. production of pharmaceutical-grade ibogaine API under cGMP standards.
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Benuvia Holds ~50% of U.S. Ibogaine Quota
Benuvia operates an 83,000-square-foot DEA-registered facility and currently holds approximately half of the U.S. aggregate production quota for ibogaine, providing an established foundation for domestic production.
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Regulatory Approvals Still Required
Applications for the import permit and procurement quota required for planned production are being advanced with the DEA by Benuvia; timing and scale of U.S. production will be governed primarily by DEA quotas and other regulatory authorizations.
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PsyLabs Definitive Agreement Due by Nov 30
The previously announced binding term sheet with PsyLabs for exclusive U.S. rights is to be superseded by a definitive agreement, which the parties have agreed to conclude on or before November 30, 2026.
Analysis · PBM · Life Sciences
Psyence BioMed's Texas subsidiary TIRC has signed a manufacturing services agreement with Benuvia Operations, a DEA-registered controlled-substance manufacturer in Round Rock, Texas. Benuvia operates an 83,000-square-foot facility and holds roughly half of the U.S. aggregate production quota for ibogaine. This adds a U.S.-based manufacturing pathway to the previously announced PsyLabs supply term sheet, creating a potential end-to-end domestic supply chain for pharmaceutical-grade ibogaine. The partnership is contingent on DEA import permits, procurement quotas, and other regulatory authorizations, and the definitive PsyLabs agreement must be concluded by November 30, 2026.
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At the time of this filing, PBM was trading at $5.35 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $19.7M. The 52-week trading range was $1.92 to $28.13. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.