Otsuka Holdings Co., Ltd.

The FDA said Friday it has issued new fast-track vouchers to three psychedelic companies, and its selections have come as a “surprise” to Wall Street. In an unusual move, the agency didn’t name the sponsors or their programs in its announcement, but said the Commissioner’s National Priority Vouchers are going toward companies that are advancing psilocybin for treatment-resistant depression, methylone for post-traumatic stress disorder and psilocybin for major depressive disorder. Compass Pathways confirmed it was one of the recipients in a press release issued hours later. A source familiar with the announcement told Endpoints News that the other two recipients are Transcend Therapeutics and the Usona Institute. Transcend declined to comment, and Usona did not immediately respond to a request for comment. Compass was widely anticipated to be a CNPV recipient after President Donald Trump signed an executive order last week to “accelerate treatments for serious mental illnesses.” Compass’ psilocybin-based treatment-resistant depression drug, COMP360, already has positive Phase 3 data as well as breakthrough therapy designation. But the other choices are a little “surprising,” Stifel analyst Paul Matteis told Endpoints in an interview. Transcend’s methylone program, called TSND-201, is in Phase 3 development for PTSD. The biotech is being acquired by Otsuka. Meanwhile, the Usona Institute is running a Phase 3 trial of psilocybin in major depressive disorder. Last week, Matteis wrote that Definium Therapeutics was an “obvious” choice for a CNPV thanks to “outstanding” Phase 2 data for its generalized anxiety disorder treatment, called DT120, which is a formulation of LSD. But that compound didn’t appear on Friday’s list. DT120 is approaching a Phase 3 readout later this year. Definium CEO Robert Barrow told Endpoints on Friday the company had “absolutely expressed interest” in a CNPV. “For the companies that applied for and received vouchers, presumably giving them some excitement about a faster path forward, that’s great,” Barrow said. “We believe we’ve got a drug that has potential to have as much or more impact than anyone.” In addition to encouraging CNPVs for psychedelics, Trump’s executive order also contains provisions to match state investments in psychedelic research and instructs the FDA and DEA to expedite rescheduling of some of these drugs when appropriate once they release Phase 3 data, rather than after receiving FDA approval. Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here. Max Bayer contributed reporting.

Moving quickly under President Donald Trump's executive order, the FDA on Friday awarded three Commissioner's National Priority Vouchers (CNPVs) to companies developing psychedelic therapies for mental health disorders. Compass Pathways was one such recipient, with its candidate – a synthetic formulation of psilocybin called COMP360 – holding a Breakthrough Therapy designation for treatment-resistant depression (TRD). The US regulator also granted the drugmaker's rolling NDA submission and review request for COMP360, whose marketing application in TRD includes data from a pair of Phase III trials that met their primary endpoint. With the CNPV in-hand, Compass may now benefit from a one to two month review of its psilocybin-based treatment. "Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigor, and regulatory compliance," Compass CEO Kabir Nath said in a statement. "We are confident we meet these standards."Psychedelic potential While the FDA didn't name the other two CNPV recipients, one was awarded to a company developing a psilocybin-based agent for major depressive disorder (MDD). A possible recipient is Helus Pharma, whose deuterated psilocybin analogue HLP003 is in Phase III testing for MDD and has received Breakthrough Therapy designation for the adjunctive treatment of the mood disorder.The third voucher went to a firm developing methylone — a synthetic stimulant structurally similar to MDMA — for post-traumatic stress disorder (PTSD). The recipient here may be Transcend Therapeutics and its neuroplastogen, TSND-201. The candidate, a formulation of methylone designed to be non-hallucinogenic, has Breakthrough Therapy status for PTSD (see – Spotlight On: Neuroplastogens hit the mainstream in 2024. What's next for trip-less psychedelics?).Transcend started a Phase III PTSD trial of TSND-201 this month, according to ClinicalTrials.gov. The company is in the process of being bought by Otsuka Pharmaceutical in a deal worth up to $1.2 billion.  Helus and Transcend did not immediately respond to requests for comment.Guidance incomingThe FDA also gave a boost to an earlier-stage psychedelic. This week, the agency cleared DemeRx to begin a Phase I trial of DMX-1001 (oral noribogaine) to treat alcohol-use disorder (AUD). The company expects to launch a Phase II study next year.The neuroplastogen is a derivative of ibogaine, a psychoactive indole alkaloid derived from the African Tabernanthe iboga shrub. According to DemeRx, DMX-1001 is designed to reverse the effects of AUD and lower the risk of relapse by promoting long-lasting neural connections through neuroplasticity and normalising neurotransmitter signalling.To support further psychedelic development, the US regulator said it will "imminently" release final guidance on how to design and conduct an adequate and well-controlled study evaluating a serotonin-2A agonist. The report will also feature recommendations on data collection and generation, as well as patient monitoring.

Today, a brief rundown of news from Eli Lilly and the Food and Drug Administration, as well as updates from Regeneron, Amgen, BridgeBio Oncology Therapeutics and Novo Nordisk that you may have missed.Eli Lilly shares sagged Friday after the latest weekly prescription numbers for its obesity pill Foundayofell short of investors lofty expectations. According to IQVIA data shared with analysts at RBC Capital Markets,U.S. prescriptions totaled 3,707 for the week ending April 17, jumping 2,317 from the 1,390 figure reported over the drugs first two days on the market. By comparison, Novo Nordisks rival pill Wegovy hit 3,071 over its first full week and climbed to 18,410 the following week,wrote RBCs Trung Huynh. According to Huynh, some investors had initially projected as much as $5 billion in 2026 sales for Foundayo, but are now dialing back those estimates to around $1.3 billion to $1.5 billion a number that could be achieved if 300,000 prescriptions are written by the end of the year. Lilly shares fell nearly 5% in Friday trading, while Novos shares rose 7%. Jonathan GardnerThe Food and Drug Administration has issued three “national priority“ review vouchers to entities companies testing psychedelic medicines on forms of depression and post-traumatic stress disorder, according to a statement from the Department of Health and Human Services. Last week, the White House issued an executive order meant to encourage development of psychedelics for mental health conditions. HHS followed up Friday, revealing in a statement that the FDA is finalizing new guidance and issuing vouchers to companies studying psilocybin in treatment-resistant depression or major depressive disorder and methylone in PTSD. Compass Pathways confirmed receipt of one voucher. The others have reportedly gone to Otsuka Pharmaceutical and the non-profit Usona Institute. Ben FidlerRegeneron Pharmaceuticals has joined 16 of its peers in reaching a drug pricing deal with the Trump administration. The agreement is similar to the others the U.S. government has announced, with Regeneron gaining a three-year reprieve from tariffs in exchange for boosting domestic manufacturing and giving Medicaid most favored nation pricing for certain drugs. The company will also sell its cholesterol-lowering medication Praluent on TrumpRx, a government channel for drug purchasing, and offer its newly approved gene therapy for hearing loss at no cost.The 17 deals the administration has announced have largely eased the sectors concerns over drug pricing reforms, as they stand to have little effect on companies sales and profits. Ben FidlerAmgen on Wednesday said that longtime oncology executive, research chief and current Chief Technology Officer David Reese is retiring at the end of June. Alongside Reeses pending exit, Amgen also disclosed other changes within its executive ranks, among them Sean Bruich being tapped to serve as CTO and Jay Bradner becoming the companys executive vice president of not only research and development but also artificial intelligence and data. Amgen said these changes, effective June 1, will better align it with the evolving adoption of new technologies across the health care ecosystem. Ben FidlerBridgeBio Pharmas cancer-focused spinout BridgeBio Oncology Therapeutics has also switched up its leadership team as part of a transition into a new phase of development, the company said Wednesday. Effective April 20, Pedro Beltran will step in as CEO and Idan Elmelech will be the companys chief operating officer, while current leader Eli Wallaceshifts to senior adviser.BridgeBio leader Neil Kumar, meanwhile, has been appointed as executive chairman. The company claimed this next generation of leadership will help it execute with strategic precision and purpose. BridgeBio Oncology has three cancer drugs in early-stage testing for RAS-driven tumors. Delilah AlvaradoNovo said Thursday that an oral version of semaglutide, the active ingredient in multiple of its obesity and diabetes drug,produced positive results in a late-stage trial of children and adolescents with type 2 diabetes. After 26 weeks of treatment, Novos pill significantly lowered blood sugar when compared to a placebo in Type 2 diabetics between the ages of 10 and 17.Novo currently markets the therapy for adults in the U.S. and Europe as Rybelsus; itll be sold for adolescents as the Ozempic pill, the company said. Delilah AlvaradoEditors note: This story has been updated with the recipients of the FDAs latest national priority vouchers. '