In this week’s Trade To Black Podcast, TDR Founder Shadd Dales, lead financial writer Benjamin A. Smith and TDR contributor Anthony Varrell give their macro outlook in the cannabis, crypto and psychedelic sectors—the latter boosted early year on the promise of regulatory approval of services (MDMA).
As sentiment in the U.S. cannabis sector remains dour following anticipated regulatory reform hit a snafu in Congress, psychedelics stocks have taken an opposite turn so far in 2023. Buoyed by regulatory prospects of its own, investors have waded back in, with drug developers and clinic therapy providers receiving similar attention. Particular for the latter, sentiment has remained elevated following significant news from the Multidisciplinary Association for Psychedelic Studies’ (MAPS) clinical research program, which achieved an important milestone
Last week, the psychedelic industry’s premier research and advocacy organization reported that its MAPP2 study—the second Phase 3 trial of MDMA-assisted therapy—achieved a successful confirmatory Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD). In essence, the results confirmed its earlier MAPP1 study, thereby greatly increasing the likelihood that MDMA assisted therapy will be approved for the treatment of PTSD.
Previously and before this latest data was released, Numinus Wellness CEO Payton Nyquvest expressed optimism that MDMA assisted therapy could be approved this year should this anticipated MAPP2 study prove successful. Numinus has been a beneficiary of the early year move higher in psychedelic sector, with his company’s stock (TSE: NUMI) (OTCMKTS: NUMIF) stock rising 27.02% since December 31, 2022.
On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that are intended alone or in combination with one or more other drugs to treat a serious or life-threatening condition; and preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies.
Breakthrough Therapy Designation allows the FDA to work closely with industry organizations like MAPS to provide guidance on the development of MDMA for post-traumatic stress disorder to design and conduct the development program as efficiently as possible.
Click on the embedded link to view the broadcast in full.