NEW YORK, April 19, 2026, 12:42 EDT
Psyence Biomedical Ltd., which trades on the Nasdaq, caught attention after President Donald Trump signed an order on April 18 aimed at accelerating research into psychedelic drugs—including ibogaine, now under study for addiction and PTSD. Reuters market data showed shares of Psyence jumped 29.5% to $7.60 at the close on April 17, as the company reacted positively to news that Washington was set to act.
Timing is key here: the White House order promises speedier FDA reviews for certain psychedelic drugs, a Right to Try route for patients chasing experimental therapies, and $50 million in federal funds to back state-level research. For clinical-stage biotech Psyence, the appeal is more straightforward. The company says it’s ready to provide ibogaine produced to GMP—good manufacturing practice—standards, the benchmark for regulated drug supply.
The order stops short of legalizing the compound. According to the White House, a rescheduling review hinges on successful Phase 3 clinical trials and FDA sign-off. But FDA Commissioner Marty Makary said a decision might arrive “as soon as this summer.” The White House
Psyence CEO Jody Aufrichtig pointed to “increasing global interest” in ibogaine and said the company has put together an “ethically grounded supply chain” that’s ready for large-scale trials. According to the company, its investment in PsyLabs delivered GMP-compliant ibogaine manufacturing and access to source-level supply inside the drug’s African ecosystem. GlobeNewswire
Psyence isn’t putting ibogaine clinical results front and center. Instead, its main focus is NPX-5—a natural psilocybin capsule currently in Phase IIb testing in Australia. The trial targets adjustment disorder among cancer patients in palliative care. Back on April 8, the company said the study’s network had grown, moving from three clinical sites up to five.
Psyence lags behind Compass Pathways at the public trial stage. Compass CEO Kabir Nath called the April 18 order a move that could quicken access “without compromising rigorous science.” The company says it’s already in talks with the FDA, submitting pieces of its COMP360 application after strong Phase 3 results, while Psyence’s top program is still stuck in Phase IIb. Via Ritzau
The White House policy adjustment doesn’t make it easier to clear the evidence hurdle. “Nothing about any of this should lower the bar,” Definium Therapeutics CEO Rob Barrow told STAT. In 2024, Reuters noted that the FDA had rejected Lykos Therapeutics’ MDMA-based PTSD treatment. Meanwhile, Psyence’s filings highlight its own challenges: no approved products, no current revenue, ongoing financing needs, and the risk that falling out of compliance with Nasdaq could affect both liquidity and the share price. STAT
Psyence is focusing on supply-chain readiness as it pushes forward with drug development. The company argues that standardized, ethically sourced ibogaine could become crucial as regulations shift. Still, in its own words, there’s no guarantee the recent White House directive will have any major impact on its business or regulatory process.
