Executive Order Accelerates Psychedelic Drug Reviews, GH Research Stock Jumps 14-18%
President Trump signed an executive order directing FDA to issue priority review vouchers for psychedelic drugs with breakthrough therapy designations, compressing review timelines to 1-2 months and mandating clearer pathways for rescheduling Schedule I substances. GH Research shares rose 14-18% following a $50 million investment in ibogaine research.
1. Executive Order Details
The executive order directs the FDA to issue priority review vouchers for psychedelic programs with breakthrough therapy designations, potentially reducing typical review timelines from six-to-ten months to one-to-two months, and instructs the FDA and DEA to establish clearer pathways for patient access and initiate rescheduling of psychedelics from Schedule I.
2. Impact on GH Research Stock
GH Research shares jumped between 14% and 18% in premarket trading following the announcement, reflecting investor optimism about the company’s prospects for accelerated regulatory review and potential market entry of its psychedelic therapy candidates.
3. Funding for Ibogaine Research
The order includes a $50 million federal investment in ibogaine research, which could support ongoing and planned trials by companies like GH Research that are exploring psychedelic treatments for PTSD and addiction.
4. Future Commercialization Pathway
Analysts expect aligned executive branch support to boost investor interest heading into potential FDA approvals between 2027 and 2030, enhancing GH Research’s valuation outlook as its breakthrough therapy-designated programs move closer to commercialization.