<div id="readability-page-1"><div> <p>At least half a dozen biotechnology companies working on psychedelics saw their stocks rise following an executive order from the White House meant to encourage the development of these drugs for mental health.</p> <p>The order, issued Saturday, directs the head of the Food and Drug Administration to provide a new — and controversial — kind of voucher to “appropriate” psychedelic medicines that the FDA has classified as potential breakthroughs for serious conditions. That classification, as well as the “national priority vouchers,” are designed to significantly speed up the development and regulatory review of certain therapies.</p>   <p>Additionally, the Trump administration wants the FDA and the Drug Enforcement Administration to assist in setting up a pathway for eligible patients to get ahold of psychedelic medicines under the Right to Try Act. Other provisions include instructions for the Department of Health and Human Services to collaborate with state governments and the Department of Veterans Affairs to advance the research and testing of psychedelics.</p> <p>“It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America,” President Trump wrote.</p> <p>The order specially mentions ibogaine, a psychoactive compound found in shrubs native to central Africa. But on Wall Street, analysts view the mandate as a major win for psychedelics developers broadly. Andrew Tsai, of Jefferies, called it “an official stamp of validation to the class” and evidence that the White House and these agencies plan to support psychedelics in “real” and “actionable” ways.</p> <p>Shares of several developers subsequently spiked by high single-digits or more. One, Enveric Biosciences, nearly tripled. The Cambridge, Massachusetts-based biotech is working on an analog to a hallucinogenic compound known as “DMT.” It’s supposed to rewire brain circuitry by interacting with two kinds of proteins that regulate serotonin and, by extension, affect mood, emotions and cognition.</p> <div> <h6>Stock changes of select psychedelics developers</h6> <table> <thead> <tr> <th>Company</th> <th>Ticker</th> <th>Friday close</th> <th>Monday High</th> <th>Percent change</th> </tr> </thead> <tbody> <tr> <td>Helus Pharma</td> <td>HELP</td> <td>$5.50</td> <td>$6.00</td> <td>9%</td> </tr> <tr> <td>Definium Therapeutics</td> <td>DFTX</td> <td>$22.68</td> <td>$26.25</td> <td>16%</td> </tr> <tr> <td>GH Research</td> <td>GHRS</td> <td>$18.34</td> <td>$24.66</td> <td>34%</td> </tr> <tr> <td>AtaiBeckley</td> <td>ATAI</td> <td>$4.03</td> <td>$5.50</td> <td>36%</td> </tr> <tr> <td>Compass Pathways</td> <td>COMP</td> <td>$6.66</td> <td>$10.21</td> <td>53%</td> </tr> <tr> <td>Enveric Biosciences</td> <td>ENVB</td> <td>$1.82</td> <td>$5.43</td> <td>198%</td> </tr> </tbody> </table> </div> <p>SOURCE: Yahoo Finance data</p>   <p>To Brian Abrahams, an analyst at RBC Capital Markets, the two most directly beneficial pieces of the order are the national priority vouchers for drugs with breakthrough designation and the DEA directive to quickly reschedule psychedelic drugs post-approval. Both of those elements “should shave additional months off of FDA review and accessibility and accelerate potential revenue generation,” Abrahams wrote in a note to clients.</p> <p>In his own note, Stifel’s Paul Matteis wrote that FDA Commissioner Martin Makary said three psychedelics that go after a particular serotonin receptor may receive a voucher this week.</p> <p>The two most obvious potential recipients, according to Matteis, are Compass Pathways and Definium Therapeutics. Compass has scored positive data in two late-stage studies for “COMP360,” a synthetic form of psilocybin that’s on track to becoming the first “classic” psychedelic cleared for the U.S. market. Meanwhile, Definium, formerly named MindMed, has a synthetic derivative of LSD that’s progressed to Phase 3 testing as a possible treatment for major depressive disorder and generalized anxiety disorder.</p> <p>Who the third voucher might go to is less clear, but overall “this is a tailwind for the space,” Matteis wrote.</p> <p>Analysts agreed the order helps de-risk a research area that at least some investors had grown more wary of over the past couple years. Fueling that skepticism was the FDA’s rejection of MDMA-assisted therapy for PTSD, and a report from Stat News that COMP360 had previously been blocked from inclusion on the agency’s voucher list.</p> <p>Tsai, of Jefferies, highlighted other recent developments that have helped improve the sentiment around psychedelics. Top officials at the FDA and HHS, like Makary and Robert F. Kennedy Jr., have voiced support for these types of drugs. The field has also benefited from deals — like those between Otsuka Pharmaceutical and Transcend Therapeutics and AbbVie and Gilgamesh Pharmaceuticals — as well as the commercial success of Spravato, a ketamine-derived depression therapy from Johnson &amp; Johnson.</p> <p>“Net-net: The culmination of these factors makes us believe psychedelics are an investable space,” Tsai wrote.</p> </div></div>

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<p>An executive order from President Trump has led to a surge in stocks of biotechnology companies focused on psychedelics, as it aims to expedite the development of these drugs for mental health. The order includes provisions for the FDA to issue national priority vouchers for breakthrough psychedelic medicines and to facilitate patient access under the Right to Try Act. Analysts view this as a significant boost for the psychedelics sector, with companies like Enveric Biosciences seeing stock increases of nearly 200%. Overall, the order is expected to accelerate FDA reviews and enhance revenue potential for these companies.</p>

Trump executive order lifts psychedelics biotechs