Trump said a 1994 IND transfer could speed ibogaine development. Psyence BioMed, with GMP manufacturing via PsyLabs, says it is ready to help lead clinical work.
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President Trump announced Monday that the University of Miami has turned over its 1994 Investigational New Drug application for ibogaine to the federal government. He said the transfer could help accelerate the psychedelic compound's path toward becoming an approved medical treatment in the U.S.
The White House also highlighted progress since Trump's April executive order on ibogaine: HHS research funding, a collaboration with the Department of Veterans Affairs, new FDA guidance, and expanded Right to Try access for veterans. Trump ended the statement by calling for more companies and institutions to get involved.
Psyence BioMed (Nasdaq: PBM), a biopharmaceutical company focused on nature-derived psychedelic compounds, welcomed the announcement. CEO Jody Aufrichtig said the federal push lines up with the manufacturing and clinical platform the company has been building.
"This is what Psyence BioMed was built for," Aufrichtig said in a statement. "The President has made clear that the United States wants serious companies and institutions to step forward and help advance ibogaine. We are ready to answer that call."
Psyence BioMed holds an ownership interest in PsyLabs, a pharmaceutical manufacturer that produces GMP-compliant psychedelic active pharmaceutical ingredients, including ibogaine hydrochloride. PsyLabs operates from an ISO 22000 and GMP-compliant facility and already holds an inventory of pharmaceutical-grade ibogaine hydrochloride. The company said that inventory and the manufacturing capacity could support clinical development if regulatory pathways open up.
"The conversation around ibogaine has changed dramatically," Aufrichtig continued. "This is no longer a discussion taking place at the margins of medicine. The White House, HHS, the VA, FDA, researchers and states are increasingly asking how ibogaine can be studied safely, responsibly and at the standards expected of a pharmaceutical medicine. Those are exactly the questions we have been preparing to help answer."
Aufrichtig and CFO Warwick Corden-Lloyd are in Texas this week meeting with stakeholders and other leaders in the emerging U.S. ibogaine ecosystem. They are discussing recent policy progress and opportunities to advance regulated clinical development. "The timing of the President's announcement is particularly meaningful," Aufrichtig added. "There is a real sense of urgency around this work, particularly for veterans, and Psyence BioMed intends to be an active participant in determining what comes next."
The April executive order directed HHS to fund research into ibogaine as a potential treatment for traumatic brain injury and PTSD in veterans. Monday's announcement adds a specific regulatory asset -- the original IND -- which the administration said could help bypass some early-stage research hurdles.
Psyence BioMed is one of the few vertically integrated psychedelic biopharma companies listed on Nasdaq. Through PsyLabs, it can cultivate, extract and export psilocybin, ibogaine, mescaline and DMT to legal research markets. The company has already shipped psilocybin products to Canada, the UK, Portugal and Slovenia.
The company's forward-looking statements caution that no executive action may ultimately expand research opportunities or benefit Psyence BioMed. Ibogaine remains a controlled substance in the U.S., and regulatory pathways for psychedelic medicines are still evolving. The administration's repeated focus on ibogaine has given the sector a clearer signal than it had a year ago, several biotech analysts noted.
Psyence BioMed's stock has been volatile since its Nasdaq listing, trading largely on the promise of regulatory catalysts. Monday's announcement did not trigger a major move in after-hours trading. One biotech analyst, speaking on condition of anonymity because he was not authorized to comment publicly, said: "If the government is putting real resources behind ibogaine research, companies with existing GMP supply are the logical partners. Psyence BioMed's PsyLabs stake gives it a tangible asset that most peers don't have."
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