Two Psychedelic Drugs Got Rejected. Both Are Back at the FDA's Door — And the VA Just Widened the Stakes

Two companies that got sent home by the FDA are both walking back through the same door this month, and neither is being quiet about it.

Resilient Pharmaceuticals — the rebrand of Lykos Therapeutics, the company whose MDMA-for-PTSD application got torched in August 2024 — resubmitted its New Drug Application around August 9. An NDA is just the formal ask to sell a drug; the FDA’s original rejection came as a Complete Response Letter, which is regulator-speak for “no, and here’s why,” in this case citing blinding failures and data-integrity problems in the trial (patients on MDMA can usually tell they got MDMA, which makes the placebo comparison shaky). The agency had wanted a new Phase 3 trial — the last and largest human testing stage before approval. Resilient didn’t run one. Instead it’s leaning on a third-party audit of the old data, a fresh cardiac-safety study, and VA follow-up data, betting a roughly six-month review clock will land differently this time.

Compass Pathways, meanwhile, is in a stronger position: two positive Phase 3 trials for its psilocybin therapy COMP360, and a rolling NDA submission already underway. As of this month, zero classic psychedelics — psilocybin, MDMA, LSD, DMT, ibogaine — are FDA-approved for anything. Two companies are now closer than any have ever been.

This is real regulatory correction for Compass, and a calculated political bet for Resilient — the two filings are different species, not one shared comeback story. Compass generated the trial the FDA asked for and is filing on the strength of it. Resilient is resubmitting the same underlying data with an audit stapled on, explicitly skipping the redo the agency requested, and doing it under a new administration it’s evidently hoping will read “blinding failure” as a technicality rather than a disqualifier. That’s not correction. That’s a company reading the political weather.

Here’s why this matters for recovery specifically, not just PTSD: under VA Chief of Staff Curt Cashour, the VA is running its 20th active psychedelic-therapy trial, backed by more than $23 million in outside funding — and this round explicitly includes MDMA for alcohol use disorder, alongside psilocybin for treatment-resistant depression and GLP-1 drugs for AUD. That’s a federal health system building the access pipeline for substance use treatment before either drug has cleared the FDA. If Compass gets approved on the strength of real data and Resilient gets approved on the strength of political timing, both drugs land inside the same VA infrastructure and reach the same veterans with substance use disorders — no separate bar for the one that didn’t earn it the hard way.

Two companies, two different paths back to the same regulator, and only one of them actually did the work the FDA asked for.