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Three Psychedelic Companies Just Got TSA PreCheck for FDA Approval
Six days after President Trump signed an executive order directing the FDA to fast-track psychedelic therapies, the agency handed priority review vouchers to Compass Pathways (psilocybin for treatment-resistant depression), Usona Institute (psilocybin for major depression), and Transcend Therapeutics (methylone for PTSD). These vouchers could compress FDA review from roughly a year down to eight weeks. Compass, which succeeded in both of its Phase 3 trials and raised $150 million in a public offering in February, could see an approval decision as early as Q1 2027. It would be the first psilocybin drug on the U.S. market.
Why it matters: After the FDA rejected MDMA therapy for PTSD in 2024, the psychedelic medicine sector looked stalled. This coordinated push, combining a presidential executive order with a novel voucher program and $50 million in federal research funding, represents the most concrete federal support the industry has ever received.
Read more →Policy & Regulation
The Executive Order That Lit the Fuse
Trump's April 18 executive order didn't just suggest the FDA be nicer to psychedelics; it directed the agency to issue priority vouchers, told the DOJ, HHS, VA, and FDA to collaborate on labeling and scheduling considerations after FDA approval, and allocated $50 million in HHS funding for federal-state research collaborations. It also opened Right to Try pathways for investigational psychedelics, putting veterans and first responders at the front of the line.
Read more →Deals & M&A
Amneal Agrees to Pay Up to $1.1 Billion for Biosimilar Factories (Yes, Factories)
With $300 billion in branded biologics losing patent protection over the next decade, Amneal is betting that the real bottleneck isn't inventing biosimilars but making them. The Kashiv BioSciences deal, valued at up to $1.1 billion including $375 million in cash, $375 million in equity, and up to $350 million in milestones, brings four manufacturing sites, plans to nearly triple capacity to 75,000 liters by 2028, and a pipeline targeting six commercial biosimilars by 2027.
Read more →WCG Buys an AI Contract Platform to Speed Up Trial Paperwork
Clinical trial contracts are a silent time killer: 35% of research sites call study start-up a major challenge. WCG acquired The Contract Network, an AI platform that generates first-draft contract markups in minutes and predicts delays before they snowball. The tool will fold into WCG's ClinSphere platform, adding contract automation to an already broad trial operations suite.
Read more →IPO Watch
Kailera's $625M Debut Is Nasdaq Biotech's Biggest IPO Ever
A company that didn't exist two years ago just raised $625 million and surged 63% on day one, hitting a $3.1 billion valuation. Kailera Therapeutics has four GLP-1 obesity drug candidates licensed from China's Hengrui, a CEO who previously sold two companies for a combined $10+ billion, and a market that simply cannot get enough of weight-loss plays.
Read more →Alamar's 11x Oversubscribed IPO Signals Life for Tools Companies
Alamar Biosciences raised $191 million at the top of its range, and shares popped 33% on day one. The company's NULISA platform reads blood proteins at concentrations roughly 10,000 times lower than standard tests. With $74 million in trailing revenue (unusual for a biotech IPO), investors treated it as a tools company with real traction, not just a science project.
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