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The U.S. Food and Drug Administration (FDA) has issued a complete response letter for MDMA-assisted psychotherapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times reported, this decision puts on hold what could have been a landmark approval for the treatment of PTSD with MDMA, also known as midomafetamine.
Despite the setback, Lykos Therapeutics, the company behind the MDMA-AT treatment, remains determined. Lykos has expressed confidence that the FDA's concerns could be addressed using "existing data, post-approval requirements or through reference to the scientific literature." Discussions between the company and the FDA are ongoing, as Lykos seeks a clear path forward.
While MDMA's future remains in question, several other psychedelic treatments continue to progress through clinical trials. Atai Life Sciences (NASDAQ:ATAI) recently announced promising results from a phase 1b trial of VLS-01, a buccal film formulation of N,N-dimethyltryptamine (DMT), for treatment-resistant depression (TRD). The next phase 2 study is expected to start by the end of 2024, focusing on safety, efficacy and durability of response.
Numinus Wellness (OTC:NUMIF), another key player in the psychedelic space, is moving forward with studies involving Cybin's CYB003, a deuterated psilocybin molecule designed for treating moderate to severe depressive disorders. Meanwhile, Compass Pathways (NASDAQ:CMPS) is testing COMP360, a synthetic form of psilocybin, which has shown promising early results in treating PTSD. These developments highlight the continued push toward psychedelic-assisted therapies for a range of psychiatric conditions.
MindBio Therapeutics (NASDAQU:MBIO) has also made strides with MB22001, a titratable microdosing form of LSD, showing promise in phase 2a trials for major depressive disorder (MDD). They are investigating LSD's potential for treating other conditions like premenstrual dysphoric disorder and depression associated with cancer. MindMed is progressing with its own LSD compound, MM-120, which has shown potential for treating generalized anxiety disorder (GAD), with a phase 3 trial set to begin this year.
Ketamine-based therapies are advancing as well, with Awakn Life Sciences (OTC:AWAKNF) leading the charge in addressing alcohol use disorder. Their MORE-KARE phase 3 trial is underway, testing the efficacy of ketamine infusions combined with psychosocial support.
As the psychedelic field expands, all eyes are on Lykos Therapeutics as they navigate the FDA’s requirements for MDMA-assisted psychotherapy. The company has undergone a significant reorganization, including a 75% reduction in workforce, and appointed Dr. David Hough as senior medical advisor to guide the next phase of clinical work. Hough has extensive experience in psychiatric drug development, having led successful projects such as Spravato.
Rick Doblin, PhD, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), has stepped down from Lykos to focus on public advocacy for global access to MDMA and other psychedelics. Doblin’s resignation from the Lykos Board comes as the company continues its dialogue with the FDA.
Despite the challenges facing MDMA-assisted psychotherapy, the field of psychedelic research remains vibrant. With more than 185 clinical studies on psilocybin, 104 on MDMA and 58 on LSD ongoing according to clinicaltrials.gov, the future holds promise for these novel treatments. As companies continue their work, patients and researchers alike are hopeful that these therapies will become more widely available in the near future.
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