Welcome to TDRs review of the Top 5 Psychedelic developments for the week of May 9. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.
5. FDA Gives Expanded Access To MDMA As A Treatment For PTSD
Clinics in 10 U.S. cities including one in Western North Carolina have been approved by the FDA to expand patient access to MDMA. The recreational drug also known as Ecstasy, will be a treatment for post-traumatic stress disorder. The program is currently in phase three trials, but the safety and efficacy demonstrated thus far will allow forcompassionate use, with an eye on possible FDA approval next year.
What weve done for years in treatment is try to give people drugs that have tried to basically throw a blanket on those symptoms. Unfortunately, we havent done a very good job with those drugs.
Post-traumatic stress disorderhas been aroundas long as trauma has, but its only recently been recognized as a formal diagnosis, especially for members of the armed forces exposed to intense or prolonged violence. Left untreated, PTSD can lead to self-harm, and is considered a major contributing factor to the epidemic of veteran suicides.
4. Colorado Activists Collect Tens Of Thousands Of Signatures To Put Psychedelics Reform On Ballot
Colorado activists have wasted no time working to place competing initiatives to legalize psychedelics on the states November ballot, with one campaign saying that its already collected nearly half of the required signatures needed to qualify its measure.
Colorado Activists Collect Tens Of Thousands Of Signatures To Put Psychedelics Reform On Ballot: "We're excited to finalize our signature collection in the coming months and hit the ground running this fall." https://t.co/rwWhCUyWaB
Natural Medicine Colorado, a campaign backed by the national New Approach PAC, filed several versions of reform initiativesbefore deciding on one to pursuein March. It would legalize psilocybin, create licensed healing centers where people can use the psychedelic for therapeutic purposes and provide a pathway for record sealing for prior convictions.
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Recently Released Data Shows LSD Produced A Lasting And Rapid Reduction And Anxiety
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3. Psychedelic Stocks Swoon As Key Biotech ETF Makes Multi-Year Lows
The biggest psychedelic stocks mostly declined this past week, noticeable underperforming peer biopharma indexes. TheHorizon Psychedelic Stock Index ETF(PSYK) shed9.70%, while theNasdaq Junior Biotechnology Index(2.64%) andNasdaq Biotechnology Ishares ETF(0.02%) were materially stronger. The broad market slumped for a sixth consecutive week, withNASDAQ1002.54%andS&P 5002.49%falling hard, although finishing Friday on an up note. Heres how the Health Care (Biotechnology) sector performed:
Weekly technical snapshot, PSYK ETF:
In the news
A national drug policy advocacy organization is condemning how a prominent psychedelic research body responded to a B.C. womans allegations of sexual and physical abuse during clinical trials for MDMA-assisted psychotherapy.
Beckley Psytech Limited and Lophora ApS have entered into a research and development collaboration. Under the terms of the agreement Beckley Psytech will jointly fund continuing development of the Lophora pipeline and collaborate broadly on R&D.
Bright Minds Biosciences will host a symposium with Key Opinion Leaders on Dravet Syndrome and recent therapeutic developments within the competitive landscape.
Clearmind Medicine announced the filing of a provisional patent application, related to a psychedelic combination therapy treating binge behaviors that results from its recently launched collaboration with SciSparc Ltd. (NASDAQ: SPRC).
COMPASS Pathways to explore how psilocybin affects specific brain pathways in autistic adults. This will be the first ever mechanistic study of psilocybin in autistic adults.
COMPASS Pathways reported its financial results for the first quarter 2022 and gave an update on recent progress across its business. Cash and cash equivalents were $243.7 million as of 31 March 2022 compared with $273.2 million as of 31 December 2021.
Enveric Biosciences announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets to a wholly-owned subsidiary, Acanna Therapeutics Inc. by way of dividend to Enveric shareholders.
Field Trip Health announced the launch of Field Trip at Home Powered by Nue Life, which provides ketamine treatments from the comfort of a persons home.
FSD Pharma announced the closing of the sale of the Companys former cannabis processing facility located in Cobourg, Ontario, Canada for gross proceeds of CAD$16,400,000 in cash.
Kernel, a leader in non-invasive neuroimaging, and Cybin Inc. announce pilot results from a Cybin-sponsored feasibility study evaluating Kernels quantitative neuroimaging technology, Flow, to measure cortical hemodynamics while experiencing an altered state of consciousness.
Ketamine Wellness Centers announced a new partnership with the Veterans Administration (VA) inArizona. Veterans suffering from treatment-resistant depression, PTSD and anxiety will have access to ketamine therapy at the KWC Arizona clinics inPhoenix,TucsonandMesa-Gilbertat no out-of-pocket cost with prior authorization from the VA.
Mind Medicine will host a key opinion leader webinar on substance use disorders and withdrawal management onThursday, May 19, 2022at11:00am EDT.
Mindset Pharma announced that it is making headway in progressing its Family 1 lead clinical candidate, MSP-1014, towards clinical trials.
Novamind has been selected to host a clinical trial for the acute treatment of social anxiety disorder (SAD), an understudied and common mental health condition that affects nearly 15 million American adults. The phase II randomized clinical study for the acute treatment of SAD is sponsored by Bionomics Limited, a clinical-stage biopharmaceutical company listed on NASDAQ.
Ohio State University launches center to study therapeutic potential of psychedelics.
Optimi Health has completed a planned expansion of the on-site analytical laboratory at its Princeton, British Columbia facility.
Red Light Holland has engaged Akwasi Owusu-Bempah to serve as an Advisor to its Advisory Board.
Red Light Holland has submitted a Patent Cooperation Treaty application based on the provisional application it filed last year for the customization and personalization of microdosing kits and protocols based on biometric and movement data.
Revitalist Lifestyle And Wellness reported updates on strategic initiatives accomplished in April including becoming a founding partner with the American Association of Psychedelics.
Wesana Health Holdings announced that following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration, the company is expanding its lead indication for SANA-013 to Major Depressive Disorder and exploring other complementary orphan indications.
2. Senators Want Psychedelics Research Review From Federal Agencies
Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ) are pushing top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.
Senators Want Psychedelics Research Review From Federal Agencies: "Whatadditional regulatory barriers or requirements are there to studying natural or botanical psychedelics, such as psilocybin?" Sens. Brian Schatz and Cory Booker asked NIH and FDA. https://t.co/bclWfxC462
In a letter sent to the heads of the National Institutes on Health (NIH) and Food and Drug Administration (FDA) on Wednesday, the senators said that the agencies are critical to ensuring a comprehensive, rigorous, and deliberative science-based approach to the study of psychedelics. That includes the potential development of medication and therapeutics derived from these substances, they wrote.
The senators said that theyre encouraged that NIH hosted a workshop in January to explore regulatory challenges that areimpeding research into psychedelicslike psilocybin and MDMA. And they want the agencies to further expand their role in identifying research gaps, potentially promising therapeutic uses of psychedelics, and regulatory hurdles in the field of psychedelic research.
1. MindMed Collaborators Prof. Liechti And Dr. Holze Announce Positive Topline Data From Phase 2 Trial Evaluating LSD in Anxiety Disorders
Mind Medicine(NASDAQ: MNMD), (NEO: MMED) announced that Prof.Matthias Liechtiand Dr.Friederike Holze, MindMed collaborators at University Hospital Basel (UHB), have released positive topline data from a Phase 2 placebo-controlled investigator-initiated clinical trial evaluating LSD in the treatment of anxiety disorders. These findings were presented in an oral presentation atLondonsPSYCH Symposium onMay 11, 2022.
The topline data demonstrate the significant, rapid, durable, and beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression. LSD (200 g) treatment resulted in significant and strong reductions of STAI-G scores 16 weeks after treatment in the between-subjects analysis (least square mean ( SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007). LSD was well-tolerated.
Said Dr. MiriHalperin Wernli, Executive President of MindMed These results represent the highest quality research ever conducted with LSD in anxiety disorders and provide contemporary confirmation of the preliminary findings of the anxiolytic and antidepressant effects of LSD in over 500 patients to date. The statistically significant, strong and long-lasting reductions in STAI-G scores, combined with similarly rapid and sustained responses in all secondary endpoint measurements, are extremely encouraging. These results further support MindMeds clinical development strategy.
Read more:
TDR's Top 5 Psychedelic Developments For The Week Of May 9 - The Dales Report
- Review: Tripping on Utopia Complicates the History of Psychedelics - AOL - March 16th, 2024 [March 16th, 2024]
- Psychedelics Are Going Mainstream. Investing in Them Hasn't. - The Wall Street Journal - January 7th, 2024 [January 7th, 2024]
- Another Study Shows African Psychedelic Plant Ibogaine Treats Traumatic Brain Injury in Vets With 'Dramatic' Results - Good News Network - January 7th, 2024 [January 7th, 2024]
- Massachusetts Lawmakers Will Be Forced To Consider Psychedelics Legalization Measure That Activists Petitioned ... - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- VA to begin researching psychedelics as treatment option for veterans - Government Executive - January 5th, 2024 [January 5th, 2024]
- VA Is Funding New Research On Psychedelics' Benefits For Veterans With PTSD And Depression - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- VA ramps up study of psychedelic to treat PTSD - The American Legion - January 5th, 2024 [January 5th, 2024]
- Scientists predict DMT trip from cardiac activity - Big Think - January 5th, 2024 [January 5th, 2024]
- If psychedelics heal, how do they do it? | Proceedings of the National Academy of Sciences - pnas.org - January 5th, 2024 [January 5th, 2024]
- Psychedelics for acquired brain injury: a review of molecular mechanisms and therapeutic potential | Molecular ... - Nature.com - January 5th, 2024 [January 5th, 2024]
- U.S. Rep. Correa supports using psychedelics to treat veterans with PTSD - New Santa Ana - January 5th, 2024 [January 5th, 2024]
- DEA Confirms That Psychedelic Mushroom Spores Are Federally Legal Prior To Germination - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- Psychedelics for Psych Conditions Made Their Mark in 2023 - Medpage Today - January 5th, 2024 [January 5th, 2024]
- 2023: A Good Trip Around the Sun for Psychedelics - The National Law Review - January 5th, 2024 [January 5th, 2024]
- Understanding the Role of the FDA in Advancing Psychedelic Therapy - Medriva - January 5th, 2024 [January 5th, 2024]
- MAPS PBC Closes $100m Series A, Rebrands to Lykos Therapeutics - Psychedelic Alpha - January 5th, 2024 [January 5th, 2024]
- Closing the innovation gap: Advancing psychedelic therapy and medicines in EU mental health care - Open Access Government - January 5th, 2024 [January 5th, 2024]
- The Austin Chronic: SXSW Is High on Psychedelics, as Cannabis Programming Wanes - Austin Chronicle - January 5th, 2024 [January 5th, 2024]
- This Forgotten Psychedelic Could Revolutionize Traumatic Brain Injury Treatment - Inverse - January 5th, 2024 [January 5th, 2024]
- A 'milestone' for psychedelics: Pentagon directed to study alternative treatments for veterans - Washington Times - January 5th, 2024 [January 5th, 2024]
- Psychedelic Drugs Are Rushing Towards Approval for Therapy. Here's What's Next - Singularity Hub - January 5th, 2024 [January 5th, 2024]
- The top 8 psychedelic books you need to read | GreenState - GreenState - January 5th, 2024 [January 5th, 2024]
- Lykos Therapeutics Secures $100M in Series A Funding, Rebrands from MAPS PBC - Green Market Report - January 5th, 2024 [January 5th, 2024]
- DEA Calls For Even More THC, Psilocybin And DMT To Be Produced For Research In 2024 - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- Here's What You Missed in Cannabis, Psychedelics This Week - TipRanks.com - TipRanks - January 5th, 2024 [January 5th, 2024]
- You're not tripping: State and local leaders give psychedelics another chance - Route Fifty - December 22nd, 2023 [December 22nd, 2023]
- Are Consciousness-Expanding Psychedelics Like Psilocybin More Effective Than Prozac, Zoloft, Xanax, and Other ... - Nautilus - December 22nd, 2023 [December 22nd, 2023]
- RFK, Ramaswamy And Williamson Push Psychedelics Reform On Presidential Campaign Trail - Marijuana Moment - December 22nd, 2023 [December 22nd, 2023]
- Peyote is the darling of the psychedelics renaissance. Indigenous users say it co-opts a sacred way of life - The Guardian US - December 22nd, 2023 [December 22nd, 2023]
- USask researchers explore untold history of psychedelics - News - University of Saskatchewan - USask News - December 22nd, 2023 [December 22nd, 2023]
- California Governor Says Psychedelics Have 'Profound' Healing Potential, But He's Undecided On Legalization Bill As ... - Marijuana Moment - September 25th, 2023 [September 25th, 2023]
- As psychedelic-assisted therapy grows, so does interest from a new group: chaplains - NPR - September 25th, 2023 [September 25th, 2023]
- This Maine City Moves Unanimously On Decriminalizing Psychedelics: Focus On Public Health - Benzinga - September 25th, 2023 [September 25th, 2023]
- Tech Leaders Are Finding Balance Through Microdosing Psychedelics - The Dales Report - September 25th, 2023 [September 25th, 2023]
- Chronic Pain Can Be Treated by Psychedelics, Survey Suggests - Psychedelic Spotlight - September 25th, 2023 [September 25th, 2023]
- Insights Into the First Psychedelic-Assisted Therapy Guidelines With ... - Psychedelic Spotlight - September 25th, 2023 [September 25th, 2023]
- Living with long-term cancer is depressing. Texas doctors say psychedelics could help - The Hill - July 19th, 2023 [July 19th, 2023]
- Couples Are Doing MDMA and Ketamine Therapy To Save Their Relationships - VICE - July 19th, 2023 [July 19th, 2023]
- The Way People Are Using Psychedelics Is Changing Amid Reform ... - Marijuana Moment - July 19th, 2023 [July 19th, 2023]
- [WATCH] Turn on, tune in, legalise: Could psychedelics be next in ... - MaltaToday - July 19th, 2023 [July 19th, 2023]
- Will Psychedelics Be Rescheduled After FDA Approval? - Harris Bricken - July 19th, 2023 [July 19th, 2023]
- The Psychedelic Preparedness Scale: A Tool to Optimize Trip ... - Filter - July 19th, 2023 [July 19th, 2023]
- How to Test Psychedelics for Adulterants with Testing Kits - Psychedelic Spotlight - July 19th, 2023 [July 19th, 2023]
- Cannabis Science Conference to debut in Providence, R.I., with ... - GlobeNewswire - July 19th, 2023 [July 19th, 2023]
- New Speaker Rivas weighs in on psychedelics, housing and health care worker minimum wage - Yahoo News - July 19th, 2023 [July 19th, 2023]
- TDR's Top 5 Psychedelic Developments For The Week Of July 10 - The Dales Report - July 19th, 2023 [July 19th, 2023]
- Psychedelic Treatment with Psilocybin Relieves Major Depression, Study ... - February 20th, 2023 [February 20th, 2023]
- Johns Hopkins Launches Center For Psychedelic Research - February 20th, 2023 [February 20th, 2023]
- Psilocybin Treatment for Major Depression Effective for Up to a Year ... - February 20th, 2023 [February 20th, 2023]
- Inside the Johns Hopkins Psilocybin Playlist - Hopkins Medicine - February 20th, 2023 [February 20th, 2023]
- Research Story Tip: Psychedelic Drug Psilocybin Tamps Down Brains Ego ... - February 20th, 2023 [February 20th, 2023]
- Psychedelics: Risks, benefits, and more - Medical News Today - February 18th, 2023 [February 18th, 2023]
- Psychedelic Drug Effects, Side Effects & Dangers - January 25th, 2023 [January 25th, 2023]
- Psychedelics Decriminalization Project In Berkeley, Cal Includes ... - January 6th, 2023 [January 6th, 2023]
- Ancient mummified child was drugged with psychedelics before ritual ... - December 14th, 2022 [December 14th, 2022]
- The therapeutic potential of psychedelics - Science - December 14th, 2022 [December 14th, 2022]
- Changing Lives with Psychedelics: How Connecticut researchers are using magic mushrooms to help people overcome depression, OCD - WTNH.com - November 19th, 2022 [November 19th, 2022]
- Penis Envy Mushroom | Legal Psychedelics | Magic Mushroom - November 7th, 2022 [November 7th, 2022]
- Psychedelics. Discussing natural and synthetic friends. Science, News ... - November 5th, 2022 [November 5th, 2022]
- The Harms of Psychedelics Need to Be Put Into Context - WIRED - November 5th, 2022 [November 5th, 2022]
- Packers' Aaron Rodgers says psychedelics led to his back-to-back MVP ... - October 28th, 2022 [October 28th, 2022]
- With Promise of Legalization, Psychedelic Companies Joust Over Future Profits - The New York Times - October 25th, 2022 [October 25th, 2022]
- How do psychedelics work? This brain region may explain their effects - PBS - October 21st, 2022 [October 21st, 2022]
- Why is the American right suddenly so interested in psychedelic drugs? - The Guardian - October 19th, 2022 [October 19th, 2022]
- Can Psychedelics Cure? Science Is on the Verge of Finding Out - Newsweek - October 19th, 2022 [October 19th, 2022]
- Large national survey suggests that the use of psychedelics is not associated with lifetime cancer development - PsyPost - October 19th, 2022 [October 19th, 2022]
- This Pharma Company Just Scored Another Psychedelics Patent And Set Its Sights On 70 More - Small Pharma - Benzinga - October 19th, 2022 [October 19th, 2022]
- What Made the Mushrooms Magic: Psychedelic Study Explores the Odd Evolution of Mind-Altering Fungi - The Debrief - October 19th, 2022 [October 19th, 2022]
- Psychedelics And Wellness: The Healing Company Buys PepsiCo-Backed Superfoods Company - (HLCO) - Benzinga - October 19th, 2022 [October 19th, 2022]
- What's on the Colorado ballot? Housing, psychedelics, school meals, alcohol, taxes and more | FOX31 Denver - FOX 31 Denver - October 19th, 2022 [October 19th, 2022]
- DoseConnect to Sponsor the Tech Stage at Wonderland Miami by Microdose - Benzinga - October 19th, 2022 [October 19th, 2022]
- What Is Going on With Bright Minds (DRUG) Stock Today? - InvestorPlace - October 19th, 2022 [October 19th, 2022]
- Psychedelics May Ease Fear of Death and Dying - October 17th, 2022 [October 17th, 2022]
- TDR's Top 5 Psychedelic Developments For The Week Of October 10 - The Dales Report - October 17th, 2022 [October 17th, 2022]
- DEA Wants To Boost Production Of Cannabis & Psychedelics For Research In 2023 - Benzinga - October 17th, 2022 [October 17th, 2022]
- Talk set to explore psychedelics and mental health - Reading Today - October 17th, 2022 [October 17th, 2022]
- Silo Wellness Closes Acquisition of Dyscovry Science and Its Psilocybin Pharmaceutical Biosynthesis and Research Portfolio - Yahoo Finance - October 17th, 2022 [October 17th, 2022]
- How does psilocybin rewire the brain? - Open Access Government - October 17th, 2022 [October 17th, 2022]
- HYTN Awarded Controlled Drugs and Substances Dealers License Allowing for Production and Sale of Psilocybin - Yahoo Finance - October 17th, 2022 [October 17th, 2022]
- The Healing Company acquires leading superfoods business, Your Super, and lands $150M credit facility to expand community of brands - Yahoo Finance - October 17th, 2022 [October 17th, 2022]