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Today’s lead story is about how Resilient Pharmaceuticals (formerly known as Lykos Therapeutics, and before that, MAPS PBC) has filed a renewed New Drug Application with the FDA to use MDMA in conjunction with talk therapy as a treatment for PTSD. This is a huge deal because when the FDA denied the first application for MDMA-assisted therapy in the summer of 2024, it was stated that Lykos would have to conduct another Phase 3 clinical trial. Now, however, things have changed. Jack Gorsline has the latest. You can find that story immediately below!

If you keep scrolling, you’ll find stories about the best films to watch when you’re tripping, the World Ayahuasca Forum, lab testing gas station “mushroom” products, and more.

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The pharmaceutical company once known as Lykos Therapeutics is trying again for FDA approval of MDMA therapy without an additional Phase 3 trial and with a White House eager to fast-track psychedelics.

By Jack Gorsline

Resilient Pharmaceuticals has filed a renewed New Drug Application with the Food and Drug Administration to use MDMA in conjunction with talk therapy as a treatment for post-traumatic stress disorder. The submission triggers a fresh evaluation cycle for the treatment, following the FDA's 2024 denial of the original application from Resilient — then known as Lykos Therapeutics — amid a firestorm of controversy. Notably, this latest application does not include the additional Phase 3 clinical trial data that the FDA had previously requested in its original Complete Response Letter (CRL) detailing the cause for the Agency’s initial rejection. When the agency denied the application in 2024, it highlighted three primary roadblocks: a failure to track "positive" side effects, a lack of sufficient proof regarding the treatment's long-term effectiveness, and a participant pool that included too many previous MDMA users and screening failures.

Complicating the drug's regulatory journey, the academic journal Psychopharmacology retracted three papers in August 2024 that examined the long-term results of Phase 2 MDMA trials. The journal pulled the studies due to protocol breaches that constituted unethical behavior by the involved researchers,  including not reporting “adverse positive effects,” or unintended and potentially difficult experiences during the treatment. According to the retraction statement, the authors admitted they knew about these violations but deliberately failed to notify the publication or exclude the compromised site data from their findings.

To resolve the FDA's initial concerns, the agency originally recommended that Resilient launch a fresh Phase 3 clinical trial to prove the drug's long-lasting benefits, reduce the risk of biased results, and provide a clearer picture of overall safety. However, rather than running a new Phase 3 trial, Resilient has reportedly opted to use external research to satisfy the FDA's demands. The company is pointing to outside data, including a modest Veterans Affairs study featuring long-term patient tracking, alongside at least one other dataset from an independent group.

Additionally, Resilient conducted a fresh Phase 1 clinical trial for a cohort of 32 participants. A key component of this initial study was evaluating the drug's safety by carefully tracking any negative side effects or unintended adverse reactions.

Despite the past data controversies, advocates for psychedelic-assisted therapies praised the shifting regulatory guidelines and the renewed application.

“The new guidance reflects the approaches MAPS developed with the FDA after decades of scientific collaboration,” Betty Aldworth, co-executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), said in an Aug. 9 press release. “The drug evaluation and regulation system was not designed to evaluate drugs delivered as part of therapy, and it is worth getting right. The clarity this guidance provides was earned by the researchers, therapists, and participants who believe this treatment deserves a rigorous evaluation of its scientific merit. We applaud the FDA for recognizing both the promise and the complexity of novel treatments for life-threatening mental health conditions.”

Ismail Ali, J.D., who also serves as co-executive director for MAPS, emphasized in the press release that the organization's broader mission extends beyond this single regulatory decision.

“Regardless of the outcome of any individual application, the questions now facing the field are the ones MAPS was built to answer: how therapists are trained, how patient safety and outcomes are maximized, and whether the people most affected by trauma can access the treatments research has made possible,” Ali said.

The second attempt to receive FDA approval arrives amid a rapidly shifting regulatory landscape for psychedelics. In July, the agency finalized its non-binding guidelines for psychedelic clinical research. Furthermore, the renewed push aligns with President Donald Trump's April Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness." The directive mandates that federal agencies, including the FDA, the Department of Health and Human Services, the Drug Enforcement Administration, and the VA, to expedite the research, approval, and public availability of psychedelic medicines, specifically highlighting "Right to Try" access to ibogaine and the use of Commissioner's National Priority Vouchers.

Beyond the clinical data, the resubmission lands in a political environment that is unusually favorable to psychedelics and shaped by figures with direct access to the president. . For example, Trump has publicly admitted that a text message from podcaster Joe Rogan motivated his April executive order promoting psychedelic research. The interest extends beyond Rogan to wealthy, elite circles with proximity to the administration. For instance, Genevieve Jurvetson, chair of the Psychedelic Science Funders Collaborative, was present in the Oval Office for the signing of Executive Order 14401 in April. Notably, during the Digital-Life-Design (DLD) Conference in Berlin in January 2025, Jurvetson forecasted that Resilient would successfully resubmit its application.

Resilient’s ownership also reflects the same politically connected money. Antonio Gracias — a close ally of Elon Musk and former special government employee under Trump’s now-defunct Department of Government Efficiency (DOGE) — is one of the pharmaceutical company’s biggest shareholders. As reported by The Guardian, Gracias met Rick Doblin at Burning Man in Nevada, where he initially suggested Doblin let Lykos “go bust” and start fresh. Doblin came back to him weeks later, and the two spent months working toward the takeover that closed in May 2025, with British billionaire and hedge fund manager Christopher Hohn joining to assume control. Reflecting on the original application's rejection, Doblin defended the initial clinical work submitted to the agency.

“We believed the data was valid, that the therapists did their best treating the placebo subjects as well as the subjects who received MDMA, despite partial functional unblinding, and that adverse events and clinical outcomes were reported accurately,” Doblin said in a statement to Psychedelic Alpha, “though positive adverse events had not been gathered at that time.”

Medical experts and veterans advocates similarly expressed optimism about the resubmission and the future of the treatment.

“I’m very encouraged to see the application back before the FDA,” said Dr. Franklin King, who serves as the Director of Training and Education at the Massachusetts General Hospital (MGH) Center for the Neuroscience of Psychedelics. “In my view, the evidence available in 2024 supported approval, and I was disappointed by the FDA’s decision at the time. MDMA-assisted therapy has the potential to provide an important new option for people with PTSD, and approval would also remove substantial barriers that currently make rigorous MDMA research unnecessarily difficult to conduct.”

For veterans suffering from treatment-resistant PTSD, the regulatory progress represents a critical step forward.

“For too many veterans, PTSD has been a life sentence,” Logan Davidson, policy director for Veterans Exploring Treatment Solutions (VETS), said. 

“Resilient’s resubmission is a reminder that the door on MDMA-assisted therapy isn’t closed, but it needs to open the right way. Veterans who’ve exhausted conventional treatment deserve access to therapies backed by rigorous science. This is a meaningful step toward that goal. We owe it to the men and women who served to make sure the FDA evaluates this treatment with the rigor it deserves.”

If approved by the FDA upon re-review, the official name of Resilient’s patented MDMA formula is likely to hit the market as “Rysanso,” which the company filed a Canadian trademark application for earlier this year.