Psychedelic Stocks Soar as FDA Seen Granting Emergency Use Authorizations

The FDA is likely to grant emergency use authorizations for psychedelic substances like psilocybin, boosting the sector's stocks. The shift comes after growing support within the US government for psychedelics as mental health treatments. FDA Commissioner Marty Makary has made positive remarks about the promise psychedelics hold, especially for veterans. Speculation that the FDA may issue EUAs saw shares of life sciences and biotechnology firms advancing psychedelic therapies move higher.

The Food and Drug Administration (FDA) is expected to grant emergency use authorizations (EUAs) for psychedelic substances like psilocybin, potentially boosting the sector's stocks. This shift comes after growing support within the U.S. government for psychedelics as mental health treatments. The FDA Commissioner, Marty Makary, has made positive remarks about the promise psychedelics hold, particularly for veterans [1].

In the past few months, there has been a significant increase in support for psychedelics within the U.S. government. Robert F. Kennedy Jr., now the secretary of health and human services, and other influential players in the Trump administration have voiced their support for psychedelics as potential mental health treatments. Calley Means, a White House adviser, wrote that psychedelics "should be an important public policy priority for the United States," and his sister Casey Means, the president’s surgeon general pick, described psilocybin therapy as "one of the most meaningful experiences of life…" [1].

The potential for EUAs has led to speculation that the FDA may issue authorizations, driving up the shares of life sciences and biotechnology firms advancing psychedelic therapies. For example, Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company, has announced a 50:50 joint venture with Mind Medicine Australia to launch a psychedelic-assisted therapy clinic in Melbourne [2]. This initiative aims to enhance the accessibility and quality of treatment for mental health conditions such as PTSD and treatment-resistant depression by providing a comprehensive range of services, including clinical operations and medical oversight.

The new clinic model is expected to significantly increase treatment capacity and lower costs, benefiting more patients in need. The collaboration with a leading organization in psychedelic therapies is likely to enhance Incannex's credibility and capabilities in the sector. However, the joint venture may also lead to increased scrutiny and regulatory challenges in a rapidly evolving sector [2].

In conclusion, the growing support for psychedelics within the U.S. government and the potential for EUAs from the FDA are likely to have a positive impact on the sector's stocks. Investors and financial professionals should closely monitor the developments in this area.

References:
[1] https://www.statnews.com/2025/06/18/fda-approval-psychedelics-rfk-jr-trump-allies-see-opening-mdma-psilocybin-mental-health-treatment/
[2] https://www.nasdaq.com/articles/incannex-healthcare-inc-forms-joint-venture-mind-medicine-australia-psychedelic-assisted