Psyched: Psychedelics Reimbursement, Amanita Muscaria Boom, $53M Material Breach Lawsuit & More

EXCLUSIVE: AMA Moves Toward Psychedelic Therapy Reimbursement, Filing A Gap In Regulations

The American Medical Association (AMA) is expected to issue the first code for psychedelic therapy reimbursement, following the approval of a joint application submitted by MAPS PBC and COMPASS Pathways CMPS.

On March 3, the AMA published its Panel Actions summary which included the approval of the new Current Procedural Terminology (CPT) III code.

These types of codes are temporary and allotted to emerging technologies, services and procedures aimed at data collection to substantiate more widespread usage or to provide documentation for Food and Drug Administration (FDA) approval process. Read more HERE.

Amanita Muscaria Mushrooms Are Taking The Lead In Markets As Research Ramps Up

Amanita Muscaria is the only kind of mushroom currently legal. As its health benefits are regularly being confirmed in studies, demand for related products is rapidly growing.

This scenario has compelled Colorado-based Panacea Life Sciences PLSH to conduct research and formulation design for product development expansion. 

Amanita Muscaria contains ibotenic acid, muscarine, muscazone and muscimol. Their pharmacology is “psychoactive” in the sense that it produces sedative and hallucinogenic effects as well as nausea, which is why it has been used for analgesic, anti-inflammatory and anxiolytic purposes at different doses, as well as in high concentrations to produce altered states of consciousness or inebriation. Read more HERE.

Lawsuit: GBB Drink Lab Seeks $53M From FSD Pharma For Nondisclosure Contract Breach & Trade Secret Misappropriation

GBB Drink Lab, which makes the world’s first formulated drink that aids in rapid blood alcohol detoxification, has filed a lawsuit against the psychedelics biotech company FSD Pharma HUGE.

Why? As a result of FSD Pharma’s failure to comply with a Cease-and-Desist letter sent by GBB on April 14th, 2023, GBB Drink Lab filed a $53 million complaint for material breach of a mutual nondisclosure agreement and trade secret misappropriation.

Filed on May 1st, 2023, in the U.S. District Court for the Southern District of Florida, the complaint alleges that after seven months of exploring a business opportunity of mutual interest and benefit revolving around GBB’s blood alcohol detoxification drink, FSD Pharma publicly announced the misappropriation of GBB’s trade secrets to current and prospective investors in one of its press releases. Read more HERE.

Psychedelics Reform Update

Check out the latest on the state-level policy reform front, plus Washington’s Jefferson County’s approved local psychedelics decriminalization measure, Colorado’s regulatory framework for legal psychedelics services implementation heading for the governor’s desk for a signature, the nation’s- first licensed psilocybin service center and statements by National Institute for Drug Abuse (NIDA)’s director Nora Volkow at a recent Senate hearing.

The Milestone Round

• LSD-therapy developer MindMed MNMD reported its first quarter 2023 financials and business highlights, including upcoming elections and leadership controversy.

• Incannex's IXHL Australian subsidiary has leased premises to provide psychedelic-assisted therapy, with an accompanying stock price jump. 

• Blackhawk’s MindBio has completed its shares spinout, while Irwin Naturals IWINF saw its Canadian securities paused as the company failed to file its financial statements.

• PharmaTher Holdings PHRRF submitted a fast-track application with the FDA for the use of its ketamine to treat Parkinson’s.

• Clearmind Medicine CMND is ticking the final steps before commencing its first-in-human trial on MEAI compound for the treatment of alcohol addiction.

• International IP claims advance for both a novel fungi biomass manufacturing process and novel non-hallucinogenic, psychedelic-based compounds. 

• Beckley Psytech’s Phase 2 trial on 5-MeO-DMT for Treatment-Resistant Depression (TRD) began participant dosing.

• A small study combining micro and macrodoses of psilocybin for treatment-resistant PTSD has shown initial sound positive outcomes.

• Check out Zappy Zappolin’s Benzinga-exclusive comments on breakthrough methods for delivering psychedelics, and Grammy winner Wyclef Jean’s take on cannabis, creativity and advocacy.

See Also: Last Week's Edition Of 'Psyched'

Psychedelics ETF Weekly Performance:

AdvisorShares Psychedelics ETF PSIL opened Monday, May 8 at $1.74 after prior opening at $1.71. The week saw a similar downward trend as the prior, with the lowest point achieved on Wed. 3 at $1.70. For this ETF, the yearly price range is set between $4.35 and $1.65.