The renamed successor to Lykos Therapeutics has filed its MDMA new drug application with the FDA following a $25 million rescue by SpaceX director Antonio Gracias. An agency hearing on psychedelic therapeutic uses is set for this month, and President Trump's April executive order directs the FDA to compress approval timelines from years to weeks.
Resilient Pharmaceuticals resubmitted its MDMA application to the FDA after a $25 million recapitalization, with an agency hearing on psychedelics set for this month. The company, formerly Lykos Therapeutics, is seeking approval for MDMA-assisted therapy to treat post-traumatic stress disorder.
"After losing a family member to opioid addiction, I dedicated myself to this work because I don't want other families to endure the same heartbreak," Genevieve Jurvetson, a board member of the Psychedelic Science Funders Collaborative, said.
The FDA rejected Lykos' original application in August 2024 after an advisory committee voted against approval, citing missing serious side effects in some study subjects, including suicidal thoughts. The company cut 75 percent of its workforce before Antonio Gracias, a SpaceX director and Tesla board member, provided $25 million from his family foundation to recapitalize the firm. Gracias renamed it Resilient Pharmaceuticals and moved headquarters to Chicago, home to his investment firm Valor Equity Partners.
For the resubmission, Resilient conducted a third-party audit of its prior trials to compile new data on adverse events omitted from the first application, according to people close to the company. It also launched a Phase 1 trial in April to evaluate MDMA safety in healthy adults. The company is seeking approval without a new Phase 3 trial.
President Trump signed an executive order on April 18 directing the FDA to accelerate psychedelic drug approvals from years to weeks and to issue priority vouchers to qualifying drugs with Breakthrough Therapy designations. The FDA has since issued vouchers to three companies studying psychedelics for mental health conditions. Compass Pathways, a psilocybin therapy developer, saw its stock jump roughly 40 percent in a single session after the order, while Atai Life Sciences rose about 25 percent.
Gracias has also endowed a Harvard program with a $16 million donation to fund a professorship and research on psychedelics in society and culture. Steve Jurvetson, also a SpaceX director, and his wife Genevieve have supported psychedelic medicine through their family foundation, which previously funded the Lykos drug trials. Other donors include Kimbal Musk, a Tesla director, and his wife Christiana, who funded an academic fellowship on psychedelics in society.
The global psychedelic drugs market was valued at roughly $4.1 billion in 2025, with projections for 2032 ranging from $9.5 billion to $22.6 billion depending on the forecaster. About 50 psychedelic companies now trade on public stock exchanges.
MDMA remains a Schedule I drug under federal law, and critics have raised concerns about trial methodology and the potential for abuse. Gerard Sanacora, director of the Yale Depression Research Program, said current research shows clear benefits of psychedelics for PTSD and depression but that hurdles remain. "It is very exciting but there still are some hurdles," he said.
The FDA hearing this month will test whether the regulatory environment has shifted enough for MDMA-assisted therapy to reach the market. If Resilient succeeds, it would mark the first FDA-approved psychedelic drug, opening a commercial pathway for psilocybin, ibogaine, and other compounds in development.
This article is for informational purposes only and does not constitute investment advice.
