The US FDA's independent advisory group voted against the marketing authorization application of the psychedelic medication MDMA, causing a pre-market decline in the stock of the psychedelic drug developer.
Financial news app Zhitongcaijing learned that the independent advisory group of the US Food and Drug Administration (FDA) voted against the marketing authorization application of the psychiatric medication minodafen (MDMA, commonly known as ecstasy) submitted by Lykos Therapeutics for the treatment of post-traumatic stress disorder (PTSD), which led to a significant decline in the stock prices of major psychedelic drug developers in early Wednesday trading, including Mind Medicine (MNMD.US), Atai Life Sciences (ATAI.US), COMPASS Pathways (CMPS.US), and Cybin (CYBN.US).
The FDA's Psychopharmacologic Drugs Advisory Committee's vote results showed doubts about MDMA as a treatment for PTSD. Melissa Barone, a member of the review team, said: "There are many problems with these data, and looking at them separately may not be serious, but when they accumulate, it raises questions in my mind about the effectiveness of this treatment."
Although the recommendations made by the FDA's advisory committees are not binding, regulatory agencies generally follow these recommendations when making final decisions. The final authorization decision for MDMA is expected to be announced by August 11th or earlier. If approved, it will become the first FDA-approved psychedelic-assisted therapy, which will be a significant milestone for the industry.
In addition, there are other biopharmaceutical companies that focus on psychedelic drug research in the market, including GH Research (GHRS.US), 180 Life Sciences (ATNF.US), Numinus Wellness (NUMIF.US), Revive Therapeutics (RVVTF.US), Enveric Biosciences (ENVB.US), Seelos Therapeutics (SEEL.US), SciSparc (SPRC.US), Bright Minds Biosciences (DRUG.US), Clearmind Medicine (CMND.US), and Mydecine Innovations (MYCOF.US), which may also be impacted by the results of this vote.
Investors and related companies are closely watching the FDA's final decision, as it will have a profound impact on the future of psychedelic therapy and its application in the medical field.