TDR’s Top 5 Psychedelic Developments For The Week Of December 11

Welcome to TDR’s review of the Top 5 Psychedelic Developments for the week of December 11. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Missouri GOP Lawmakers File Bills To Legalize Psilocybin Therapy And Fund Clinical Trials For 2024 Session

Missouri Republican lawmakers have pre-filed a pair of bills to legalize the medical use of psilocybin and require clinical trials exploring the therapeutic potential of the psychedelic.

Sen. Holly Thompson Rehder (R) and Rep. Aaron McMullen (R) introduced similar versions of the legislation for the 2024 session, setting the stage for further consideration of psychedelics reform in the Show-Me State.

Related: Congress greenlights psychedelic treatment bill for active duty service members suffering from PTSD

4. Congress Sends Biden Defense Bill That Would Fund Studies Into Psychedelics Therapy For Active Duty Military

A large-scale defense bill that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members is officially heading to President Joe Biden’s desk.

Days after bicameral negotiators announced they’d reached an agreement on the 2024 National Defense Authorization Act (NDAA), the Senate passed it on Wednesday and the House concurred on Thursday, sending it to the president.

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Widely Held Psychedelic Stocks Weekly Performance

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3. Psychedelic Stocks Gains As Biotech Indexes Rally

The psychedelic sector gained this week, as reflected by the Advisorshares Psychedelics ETF (PSIL) ↑2.98%. The performance underperformed the Nasdaq Biotechnology Ishares ETF↑6.37%. The broad stock market indices NASDAQ 100 ↑3.10% and S&P 500 ↑2.34% rallied again as the Fed signaled the end of the rate hiking cycle is near or has arrived.

Here’s how the Health Care (Biotechnology) sector performed:

In the news…

Australian researchers have analyzed the genetic makeup of over 100 strains of Psilocybe cubensis, a psychoactive mushroom commonly known as the magic mushroom, encompassing both commercially cultivated and wild varieties. 

Awakn Life Sciences shared a corporate update on recent progress. Awakn also announces the closing of the fourth tranche of its previously announced private placement.

Beckley Academy announced that Sara Gael Beauregard and Mary Sanders have joined the team as facilitators.

California appears to be at an “inflection point” on psychedelics reform, a state senator said last week, noting that wider acceptance of the therapeutic potential of substances like psilocybin could pave the path for enactment of a revised bipartisan bill he plans to advance in 2024.

Canadian Senate Subcommittee on Veterans Affairs recently released a striking report entitled The Time is Now: Granting Equitable Access to Psychedelic Therapies.

Drug Enforcement Administration (DEA) is taking another shot at banning two psychedelics after abandoning its original scheduling proposal last year, teeing up another fight with researchers and advocates who say the compounds hold therapeutic potential.

Dr. Mason Marks, of the Project on Psychedelics Law and Regulation at Harvard Law School, highlights growing concern about the chasm between state-level regulations and the FDA’s stance on psychedelics.

Jupiter Acquisition announced that it intends to reconvene and then adjourn today’s shareholder meeting without conducting any business until Dec. 18 at noon Eastern Time.

Kentucky advocates are pushing the state to explore a little-known psychedelic drug called ibogaine as a possible treatment option for addiction, a move, they say, could save lives. 

Numinus subsidiary Cedar Clinical Research selected as clinical research site for Beckley Psytech’s Phase 2b Study

Numinus CEO comments on MAPS PBC filing of a New Drug Application for MDMA-assisted therapy…

Psychedelic toad hunters are under attack by Mexican cartels.

Provincetown, Massachusetts, voted this week to adopt a resolution in support of decriminalizing the use, possession and noncommercial sharing of psychedelic plants and fungi. It’s the seventh municipality in the state to deprioritize arrests for entheogens.

Red Light Holland updates regarding its manufacturing plans to create medical grade homogenized natural psilocybin microdosing capsules.

Rose Hill  announced a partnership with ACS Laboratory, an award-winning testing facility. ACS Laboratory is ISO/IEC 17025:2017 accredited, DEA licensed and CLIA licensed.

Sunstone Therapies has completed more than 100 psychedelic-assisted therapy treatments, involving eight different indications, in the three years since the company was founded.

Tryp Therapeutics has entered into an Arrangement Agreement with Exopharm Limited as of December 8, 2023. According to the agreement, Exopharm will acquire all issued and outstanding common shares of through a statutory plan of arrangement under the purview of the Business Corporations Act of British Columbia.

2. MindMed’s Phase 2b Compound MM-120 Shows Promise In Treating Generalized Anxiety Disorder

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), a clinical-stage biopharmaceutical company dedicated to pioneering innovative treatments for brain health disorders, has announced topline outcomes from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) targeting generalized anxiety disorder (GAD).

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TDR Key Points

• MindMed’s MM-120 met primary endpoint, showing statistically significant dose-dependent improvement in HAM-A scores four weeks post a single dose

• HAM-A reduction of 21.3 points, a 7.6-point improvement over placebo at Week 4

• Clinical response of 78% in 100 µg and 200 µg dose groups, with a 50% clinical remission rate observed in the 100 µg dose group at Week 4

• MM-120 generally well-tolerated, with predominantly mild-to-moderate adverse events occurring on dosing day

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According to MindMed, the trial successfully met its primary endpoint, revealing statistically significant and clinically significant dose-dependent enhancements in the Hamilton Anxiety Rating Scale (HAM-A) when compared to the placebo at Week 4. The administered single dose of MM-120 exhibited robust results with no additional therapeutic intervention.

1. FDA Receives NDA From MAPS PBC Regarding MDMA-Assisted Therapy For PTSD

The moment that many psychedelic participants and investors have waited for has finally arrived. Today, MAPS Public Benefit Corporation (MAPS PBC) has formally communicated the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for MDMA (capsules) in conjunction with MDMA-assisted therapy. This intervention includes psychotherapy, colloquially known as talk therapy, along with additional supportive services administered by qualified healthcare providers.

The NDA submission encompasses findings from various studies, notably two randomized, double-blind, placebo-controlled Phase 3 trials—MAPP1 and MAPP2—assessing the efficacy and safety of MDMA-assisted therapy in comparison to a placebo complemented by therapy.