Usona files psilocybin for depression NDA as race with Compass tightens. 2 November 2026 * Where the Race Stands * After Approval: Pricing, Commercial Capabilities, and Patents * Usona's Edge: Pricing, Labelling, and No Orange Book Recourse * Compass' Counter: Bigger Trials, a Sales Force, and a Patent Estate Reporting by Josh Hardman and Noah Smith. Nonprofit psychedelic research organisation Usona Institute has completed its submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) concerning its psilocybin candidate for major depressive disorder (MDD), Psychedelic Alpha understands. It means it's the second psychedelic NDA under review by the agency at present, after we reported that Resilient Pharmaceuticals (formerly Lykos Therapeutics) refiled its MDMA for PTSD application in the summer. It also means that FDA could hand down a decision on a psychedelic application in late 2026, if the most optimistic timelines hold, or very early in the new year, given the fact that Usona, like Compass Pathways, is in receipt of a Commissioner's National Priority Voucher (CNPV) that aims to return a decision to a developer within two months. Here, we review the context surrounding Usona's program and application, and what it might mean for its chief competitor, Compass, a for-profit psilocybin drug developer that is planning to submit its own NDA, for treatment-resistant depression (TRD), imminently. Where the Race Stands. We have guided for many months that the race to approval for a psilocybin product between Usona and Compass is neck and neck: too close to call. Both programs benefit from FDA rolling review and CNPVs, as well as breakthrough therapy designation. Compass has disclosed that FDA site inspections began in September, and several Usona sites and its headquarters in Wisconsin have also been subject to agency inspections, we understand. According to sources close to Usona, who spoke with Psychedelic Alpha on condition of anonymity, the nonprofit is currently working with the agency to respond to its questions and design things like the risk evaluation and mitigation strategy (REMS) program that will govern its psilocybin product's use. Compass, meanwhile, has guided that it intends to file its NDA this quarter, though there has been no further update at the time of writing. Its quarterly update is due this week, on November 3rd. It now appears that Usona may have a slight edge, then. Still, there is a great deal that must happen between any approval and launch that Compass may retain the edge on, as we discuss later. Usona declined to comment when reached by Psychedelic Alpha. The nonprofit is, in some regards, similar to Resilient, in that it has kept quiet about its regulatory milestones of late, which have been reported largely in these pages. While Usona is careful not to telegraph its own progress, it is happy to act as a convener for others to do just that. Last Wednesday, the nonprofit gathered various stakeholders from across the psychedelics field at its campus in Fitchburg, Wisconsin, for its 'Models of Care Summit'. Attendees included other psychedelic drug developers such as Compass, AbbVie, and Otsuka, as well as... Join today. Independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and research. * Regular Bulletins featuring news, analysis, and research * Articles and deep dives across psychedelic drug development, policy, and research * Exclusive interviews with researchers, executives, and policymakers * Bespoke resources and tools including the Psychedelic Bill Tracker * Quarterly video briefings and slide decks

Weekly Psychedelic Policy Briefing: september 30th, 2026. By Jack Gorsline. In the latest Weekly Psychedelic Policy Briefing, Psychedelic State(s) of America founder and investigative journalist Jack Gorsline dives deep into the latest regulatory, legislative, and clinical landscape shifts shaping drug policy and medicine access. The Drug Enforcement Administration proposed on Sept. 23 to place five tryptamines in Schedule I. One of them, 4-OH-DiPT, is the active compound in a postpartum depression drug candidate that FDA granted Breakthrough Therapy designation in February. The notice came nine days after the FDA held a public hearing on speeding psychedelic treatments to patients under Executive Order 14401. In Oregon, the Oregon Health Authority dropped a proposal to double psilocybin license fees after public pushback, including from the state's Psilocybin Advisory Board. It has not said how it will close a projected multimillion-dollar shortfall. And a Government Accountability Office audit found DEA followed HHS's recommendation on every substance it finalized from 2020 through 2025, while neither agency has written procedures for how those decisions get made. DEA Revives Proposal to Place Five Tryptamines in Schedule I, With HHS Support DEA published a notice of proposed rulemaking on Sept. 23 to place 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT in Schedule I of the Controlled Substances Act. Administrator Terrance Cole signed it Sept. 11, three days before the FDA's hearing. A final rule would require anyone handling the compounds, including researchers, to hold a Schedule I registration. At least two of the compounds are in commercial development. Reunion Neuroscience announced Feb. 23 that FDA had granted Breakthrough Therapy designation to luvesilocin, its prodrug of 4-OH-DiPT, for postpartum depression. FDA says the designation is not a finding of safety or effectiveness, and Reunion says it plans a Phase 3 trial this year... Mindstate Design Labs reported completing a Phase 1 study of MSD-001, its formulation of 5-MeO-MiPT, in July 2025. DEA's economic analysis expects few researchers to be affected, citing the HHS finding that none of the five is subject to an investigational new drug application. The proposal does not mention luvesilocin or say whether listing 4-OH-DiPT would cover a prodrug of it. The agency proposed the same rule change back in January 2022, but after announcing a hearing that July, DEA officials withdrew both notices to seek an updated HHS evaluation. HHS delivered that evaluation on April 2, 2026, recommending Schedule I for all five. Research already underway would not stop at once. Under 21 U.S.C. 822(h), researchers registered for another Schedule I substance could continue if they apply to add these compounds within 90 days after a final rule takes effect. Others would have to stop until DEA registers them. FDA tied its Sept. 14 hearing to Executive Order 14401, which directs HHS and FDA to accelerate psychedelic research and appropriate approvals, and its hearing notice excluded the scheduling status of any substance from discussion. On Sept. 8, HHS named Michael Davis, the former chief medical officer of psilocybin developer Usona Institute, permanent director of FDA's Center for Drug Evaluation and Research, whose staff write the evaluations behind HHS scheduling recommendations. Comments and hearing requests are due Oct. 23 in docket DEA-2026-1585. Then, DEA administrator Cole will decide whether to grant a hearing before an administrative law judge. Oregon Health Authority Drops Proposal to Double Psilocybin License Fees Following significant public backlash, the Oregon Health Authority announced on Sept. 22 that it will not file final rules from its current psilocybin rulemaking and will not adopt the proposed fee increases. It cited feedback from the rulemaking, including from the Oregon Psilocybin Advisory Board. The proposal, originally proposed on June 26, would have doubled annual license fees for service centers and manufacturers to $20,000 and for facilitators to $4,000. It also would have raised worker permit fees from $25 to $200 and ended reduced fees, including those for veterans and low-income applicants, starting Jan. 1, 2027. Advocates across the state have previously said the fee-funded program is not self-sustaining, and warned that higher fees could cut the number of licensees and deepen the shortfall. A fiscal analysis OHA released under a records request projected a $3.8 million shortfall this biennium without the increase and $4.2 million if licensees quit rather than pay, the Oregon Capital Chronicle reported. OHA's statement does not say how the program will be funded in lieu of raising the licensing fees. The agency also said it will begin a new rulemaking in the coming weeks to consider the package's non-fee changes. Those included an amendment barring licensed manufacturers from providing "information or instruction related to home cultivation." Amy Charlesworth, a licensed facilitator and military veteran, pointed to the home cultivation provisions. "OHA dropping this rulemaking is a win, but it does not mean we've won," she told Psychedelic State(s) of America. The proposed rules "would have restricted licensees from 'promoting' or 'encouraging' unlawful or unregulated activity, including by 'providing information or instruction related to home cultivation,'" she said. "That is not regulation of what happens inside a licensed service center. That reaches what we write, teach, publish, and say in public. If OHA brings these provisions back, we will be ready to challenge them." Sam Chapman, executive director of the Center for Psychedelic Policy, managed the 2020 Measure 109 campaign that created the program. "We asked Governor Kotek to give the legislature time to get this right, and now they have it," Chapman told Psychedelic State(s) of America. "The program is working; the fee structure isn't." He said the center is preparing an economic analysis for the 2027 legislative session comparing state-supported psilocybin services with existing public mental health spending. OHA noted in the announcement that the agency will post the new rulemaking to its psilocybin rules page in the coming weeks, with a planned effective date of Jan. 15, 2027. GAO Finds DEA Followed HHS on Every Finalized Scheduling Decision Since 2020, Without Written Procedures A Government Accountability Office audit (GAO-26-108623) published Sept. 23 examined all 208 substances the DEA acted on between 2020 and 2025. The report revealed a consistent record of following scientific recommendations paired with a limited scope of formalized procedural rules. In all 95 instances where the Controlled Substances Act required a scientific and medical evaluation from HHS, the DEA obtained and considered one. All 84 substances that reached a final rule landed exactly where HHS recommended (an 84-for-84 record), with the remaining 11 under temporary orders. When GAO investigators examined how the agencies reach these determinations, they found limited documentation in writing. The DEA has no written policy dictating who collects preliminary data, who conducts the statutory eight-factor analysis, or how staff weigh HHS recommendations. The FDA's Controlled Substance Staff lacks formal written evaluation procedures. Furthermore, "potential for abuse," the core statutory standard governing federal drug scheduling, is defined neither in federal law nor in FDA policy, leaving decisions to professional judgment and institutional memory. Meanwhile, the formal interagency agreement governing coordination between the FDA and the National Institute on Drug Abuse (NIDA) is more than 40 years old and references offices that have long ceased to exist. For the psychiatric drug pipeline, the audit exposes the administrative vulnerabilities facing rescheduling petitions and investigational compounds. Although 21 U.S.C. 811(j) has required the DEA since 2015 to issue an interim final scheduling rule within 90 days of market approval for substances in Schedules II through V, GAO found the agency has no written procedures governing those reviews. Without codified procedures, new drug applications and rescheduling petitions for investigational substances like MDMA and psilocybin face significant uncertainty. This article was produced in partnership with Psychedelic State(s) of America - a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA's Media Partnerships Program and donate to the PSA Media Fund here. Jack Gorsline. Jack Gorsline is a Washington, D.C.-based investigative reporter covering the politics of drug policy reform - with a focus on psychedelics and cannabis legalization advocacy both in the United States and around the world. Jack's reporting has been published by the Boston Institute for Nonprofit Journalism (BINJ), Talking Joints Memo, DoubleBlind Magazine, Filter Magazine, Marijuana Moment, Psychedelic Alpha, Lucid News, Cannabis & Tech Today, Reality Sandwich, High Times Magazine, and featured by Psychedelics Today, Ecstatic Integration, and The Mycopreneur Podcast, GBH Radio, The Microdose from UC's Berkeley Center for the Science of Psychedelics, among others. Jack is also the founder of both The Psychedelic Writers Guild (PWG) and Psychedelic State(s) of America - a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA and donate to the PSA Media Fund at the link in the bio. You can find Jack on X @JackGorsline, Instagram @Jack.Gorsline, Linkedin, Substack, Bluesky, and more.