Psyence BioMed Ltd. (NASDAQ: PBM) said on Tuesday that U.S. President Donald Trump’s announcement regarding ibogaine research marks a pivotal moment for companies positioned to support the substance’s development as a therapeutic.
The president stated that the University of Miami submitted an Investigational New Drug application for ibogaine to the U.S. Food and Drug Administration in 1994, a filing intended to accelerate the drug’s progression toward medical use. Trump’s remarks follow an executive order issued earlier this year that directed federal agencies to collaborate on ibogaine research, expand funding, and broaden Right to Try access for veterans.
Psyence BioMed’s Chief Executive Officer Jody Aufrichtig said the company was built to address such opportunities. “This is what Psyence BioMed was built for,” Aufrichtig said. “The President has made clear that the United States wants serious companies and institutions to step forward and help advance ibogaine.”
Psyence’s leadership, including Chief Financial Officer Warwick Corden-Lloyd, was in Texas on Tuesday meeting with stakeholders in the U.S. ibogaine ecosystem to discuss regulatory and policy developments. The company holds an ownership stake in PsyLabs, a pharmaceutical manufacturer that produces good manufacturing practice-compliant psychedelic active pharmaceutical ingredients, including ibogaine hydrochloride. PsyLabs provides Psyence BioMed with pharmaceutical-grade manufacturing capabilities and access to existing ibogaine inventory.
Ibogaine remains classified as a controlled substance in the United States. Psyence BioMed noted it has not initiated clinical trials for its proposed ibogaine-based products and emphasized that efficacy has not been established by authorized clinical research.
