MDMA Therapy For PTSD Faces FDA Delay: Are There Other Ways Forward?
Portfolio Pulse from Juan Spínelli
The FDA has delayed the approval of MDMA-assisted psychotherapy for PTSD, requiring an additional phase 3 trial. Lykos Therapeutics is working to address the FDA's concerns. Meanwhile, other companies like Atai Life Sciences, Numinus Wellness, Compass Pathways, MindBio Therapeutics, and Awakn Life Sciences are advancing their psychedelic treatments for various psychiatric conditions.
September 13, 2024 | 12:28 am
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POSITIVE IMPACT
Atai Life Sciences is progressing with its psychedelic treatment VLS-01 for treatment-resistant depression, with promising phase 1b results and a phase 2 study expected by the end of 2024.
Atai's positive phase 1b results and upcoming phase 2 study for VLS-01 indicate progress in their psychedelic treatment pipeline, likely boosting investor confidence.
CONFIDENCE 90
IMPORTANCE 60
RELEVANCE 70
POSITIVE IMPACT
Awakn Life Sciences is leading in ketamine-based therapies for alcohol use disorder, with its MORE-KARE phase 3 trial underway.
Awakn's phase 3 trial for ketamine-based therapy in alcohol use disorder highlights its leadership in this niche, potentially attracting investor interest.
CONFIDENCE 80
IMPORTANCE 45
RELEVANCE 55
POSITIVE IMPACT
Compass Pathways is testing COMP360, a synthetic psilocybin, showing promising results for PTSD treatment, reinforcing its position in the psychedelic therapy market.
Positive early results for COMP360 in PTSD treatment could enhance Compass Pathways' market position and investor sentiment.
CONFIDENCE 90
IMPORTANCE 55
RELEVANCE 65
POSITIVE IMPACT
MindBio Therapeutics is advancing with MB22001, a microdosing LSD form, showing promise in phase 2a trials for major depressive disorder.
MindBio's progress with MB22001 in phase 2a trials for depression could boost its standing in the psychedelic treatment field.
CONFIDENCE 85
IMPORTANCE 50
RELEVANCE 60
POSITIVE IMPACT
Numinus Wellness is advancing studies with Cybin's CYB003 for depressive disorders, highlighting its role in the psychedelic treatment space.
Numinus's involvement in CYB003 studies positions it as a key player in the psychedelic treatment market, potentially attracting investor interest.
CONFIDENCE 85
IMPORTANCE 50
RELEVANCE 60