Breaking: FDA Awards Priority Review Vouchers to Otsuka, Compass, and Usona
Today, FDA announced that it has issued three Commissioner’s National Priority Vouchers (CNPVs) to three psychedelics programs, delivering on a key element of the executive order that President Trump signed on Saturday morning.
There, FDA Commissioner Marty Makary had explained that the agency would award the vouchers, which aim to reduce the review of new drug applications (NDAs) down to just one or two months, to psychedelic candidates that have received Breakthrough Therapy designation and otherwise meet the criteria for the program. He also said that three would be awarded right away.
This morning, we learned that those vouchers have been awarded to the following programs:
- Compass Pathways’ psilocybin (COMP360) for treatment-resistant depression (TRD)
- Usona Institute’s psilocybin for major depressive disorder (MDD)
- Transcend’s methylone (TSND-201) for PTSD (which is being acquired by Otsuka)
Psychedelic Alpha is unsurprised at the two psilocybin vouchers, having publicly predicted them. But we are surprised to see the agency side with Otsuka/Transcend’s methylone program over Resilient Pharmaceuticals’ MDMA for PTSD, which we had expected to receive a voucher.
FDA also announced that it will release its final guidance for sponsors developing psychedelics “imminently”.
Here, we provide a little more detail on each program, as well as the potential implications of the vouchers, which are part of a program established by the agency last summer.
Compass Pathways’ Psilocybin for TRD
This one will come as no surprise, given Compass recently shared topline data from its second Phase 3 study and has guided that it intends to submit its NDA in Q4.
It is worth recalling, however, that Compass had featured in a draft list of CNPV awards last October, but was vetoed by the White House in the eleventh hour, apparently due to concerns over how the action would be viewed by the President’s base.
FDA granted the program Breakthrough Therapy designation in late 2018.
“We are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” Compass CEO Kabir Nath said in a statement.
The company declined to comment on the agency’s issuance of a voucher to its nonprofit competitor, Usona Institute, when asked by Psychedelic Alpha.
Usona Institute’s Psilocybin for MDD
Nonprofit psychedelic drug developer Usona Institute has also received a CNPV, FDA announced today. The voucher covers its psilocybin for MDD program, which received Breakthrough Therapy designation from the agency in 2019.
As we have reported previously, we expect Usona to submit its NDA on the basis of its single Phase 3 study. Given that expectation, the package could be submitted on a similar timeline to Compass’, which is well ahead of what many were assuming.
As we wrote last December, this would raise many questions. Chief among those, for investors at least, revolve around Compass’ extent to block its nonprofit competitor from the market, should the for-profit be the first to secure an approval.
If Usona were able to manoeuvre around Compass’ psilocybin patent thicket, and any other exclusivities, we noted then, “we should expect it to have a simple strategy: relentlessly undercut COMP360’s pricing.” Still, the penalties for marketing a product that infringes on another’s IP are severe, so an enormous amount of uncertainty remains.
There’s also the question of whether Usona has the interest in or capability to launch the drug on the market, if it were approved. The company does not appear to have a notable commercial team and is not presently hiring, according to its website. It could partner with another organisation, of course.
Otsuka’s Methylone for PTSD
The surprise voucher of the trio was issued to Otsuka for the methylone (TSND-201) for PTSD program that it is acquiring from Transcend Therapeutics.
The program is entering Phase 3, making it the least mature of the trio.
On Resilient…
We had expected the third voucher to go to Resilient Pharmaceuticals (formerly Lykos Therapeutics), both due to chatter among the field and signals from the administration.
FDA issued that program a Complete Response Letter (CRL) in August 2024, declining to approve the drug, and the contents of that CRL became public in September 2025, following a decision by new FDA leadership to release 89 previously unpublished CRLs issued since 2024.
That letter outlined at least three issues that it said “preclude its approval”, including a failure to collect ‘positive’ adverse events, a lack of durability data, and high rates of prior MDMA use among study participants.
In the CRL, the agency recommended that Resilient, then Lykos, conduct a new clinical trial to address these shortcomings. It also recommended that the company consider an independent third-party audit of all study records and reports, including dosing session recordings.
While that review has commenced, a fresh Phase 3 has not.
Earlier this week, Makary told press that Resilient “has gone back and done an audit”, adding: “If that company submits the results of their audit for the protocol violation that was cited in the rejection about two years ago, before I was leading the FDA, then that’ll be considered in due process.”
Those comments had further strengthened our view that current agency leadership are not expecting a fresh Phase 3 from the company.
While we are surprised to see the FDA snub Resilient today, our view remains that the company is aiming to resubmit its NDA without an additional Phase 3 study.
Pα: The two psilocybin vouchers are entirely unsurprising and in line with our prior reporting and comments made by Makary on Saturday morning, during the signing of the executive order.
The voucher for Otsuka’s methylone, however, will come as a real surprise for many. For what it’s worth, we had expected and predicted that it would be Resilient’s MDMA program that would receive the voucher.
But with the benefit of hindsight, Resilient’s absence from today’s list is not so surprising, for several reasons. One such reason might be the optics of awarding a voucher to a program that was so publicly eviscerated by the agency and its Advisory Committee in the summer of 2024. Another consideration is whether the agency even wants to award its fast-track review vouchers to packages that are being resubmitted, as opposed to entirely new submissions. On that note, resubmissions tend to be reviewed faster than fresh NDAs, anyhow. It did seem clear, however, that the agency was keen to fast-track the review of a PTSD program, specifically, making Otsuka/Transcend’s methylone an obvious choice.
In concrete terms, we should expect the issuance of these vouchers to reduce the timeline between NDA submission and FDA approval decisions. That conventionally takes around ten to twelve months, but the agency says that receipt of a CNPV should bring that down to just one or two months. That could be an improvement of a few months or so on the base case for psychedelic drugs with Breakthrough Therapy designations, and perhaps a slightly more modest trim for those, like Compass, that appear set to benefit from rolling review. (Shortly after the FDA announced the vouchers, Compass confirmed that the agency has granted its rolling review request.)
The first new molecular entity to receive approval via the CNPV program was Eli Lilly’s Foundayo (orforglipron), a daily pill for weight management, earlier this month. That product was approved just fifty days after the NDA was submitted, providing a glimpse of just how rapid a CNPV-assisted review might be.
But the CNPV program is not without controversy, as we have reported previously, with some viewing it as lending itself to corruption and political favouritism. The latter criticism is one that the psychedelics field more broadly is increasingly exposed to, especially after Saturday’s executive order and associated signing ceremony.
Regardless, today’s announcement demonstrates an about-face by the White House, which just half a year ago moved to block a single CNPV from being issued to Compass.
Josh Hardman
Josh has been writing, talking and working on the business, science and policy of psychedelics since he launched Psychedelic Alpha in early 2020.
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