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Psychedelic Stocks Plummet After FDA Advisors Reject MDMA Therapy for PTSD

Topline
Shares for companies specializing in psychedelic medicines took a nosedive during premarket trading following the advice of independent experts against approving MDMA therapy for post-traumatic stress disorder (PTSD). This decision poses a significant setback for those looking to revolutionize medicine using these substances.

Key Facts

An FDA advisory panel voted against the use of MDMA to aid in treating PTSD due to concerns that the available evidence does not prove the drug’s effectiveness or that its benefits outweigh the risks.

While the FDA is not bound by the panel’s decision, it typically values the expert opinions it receives, marking a significant setback for companies and clinicians aiming to explore the therapeutic potential of psychedelics.

This decision has negatively impacted various companies in the field, with top firms like Mind Medicine, Atai Life Sciences, Cybin, and Compass Pathways experiencing a significant drop in share prices.

Other companies, such as Relmada Therapeutics and GH Research, also saw declines, while Seelos Therapeutics bucked the trend with a slight increase in share value.

Key Background
Psychedelics encompass a diverse range of drugs that can alter mood, thoughts, and perception. Despite their illegal status in many regions, experts view substances like MDMA, LSD, and psilocybin as promising treatments for conditions that are challenging to address. The potential therapeutic benefits of psychedelics in mental health disorders like depression and anxiety have garnered attention.

If approved, Lykos Therapeutics’ MDMA therapy would represent a groundbreaking development in the field, marking the first such approval in the U.S. and the first psychedelic therapy under FDA consideration. Clinical trials have shown promising results in reducing PTSD symptoms with minimal side effects, although concerns about cardiovascular risks persist.

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Further Reading
– Forbes: FDA Panel Votes Against MDMA As PTSD Treatment – A Potential Hitch For Drug’s Approval
– Psychedelics Are Challenging the Scientific Gold Standard
– What psychedelics legalization and decriminalization look like around the world