Psyched: FDA Warning, DEA's Telehealth Extension, CA Gov's Veto, Congress On Kratom, M&As & More

Cybin And Small Pharma Shareholders Green Light Acquisition Resolution

Clinical-stage psychedelics biotechs Canada-based Cybin Inc. CYBN and UK-based Small Pharma Inc. DMTTF held their respective annual general and special shareholders meetings on October 12. They announced that voting results favored the arrangement plan for the latter’s acquisition by the former. 

The TSX Venture Exchange conditionally approved the arrangement. Subject to the approval of BC’s Supreme Court and other customary closing conditions, the arrangement’s effective date would take place on or around October 23, 2023. Read more HERE. 

FDA Issues Warning Over Ketamine Misuse, DEA Extends Telemedicine Flexibilities

The FDA issued an alert on the dangers of self-treating psychiatric disorders with unapproved compounded versions of ketamine and ketamine-based drugs whether modified or tailored for specific patient needs.

Meanwhile, the DEA announced on October 6 that, for a second time, it is extending pandemic-established temporary rules deviating from the Ryan Haight Act conditions and effectively allowing telehealth prescriptions of controlled medications through December 31, 2024. More on both news HERE.

Gov. Gavin Newsom Vetoes California Psychedelics Bill, Leaves Door Open For Next Year

California Gov. Gavin Newsom (D) vetoed a bill on Saturday that would have decriminalized the possession and personal use of certain hallucinogens, including psychedelic mushrooms. The bill would not have legalized the sale of these substances, but rather sought to ensure that individuals were not arrested or prosecuted for having small amounts of plant-based hallucinogens. 

Newsom said in a statement that more needs to be done before California decriminalizes hallucinogens. More HERE.

Congress To Discuss Kratom Products Regulation, Introduces Bipartisan Consumer Protection Act

Congressional lawmakers from both sides of the aisle introduced a bicameral bill calling for further federal evaluation of kratom’s health and safety and prohibiting the Dept of Health and Human Services (HHS) from imposing more restrictive requirements on it than those for food or dietary supplements as a way of creating national regulations. Read more HERE. 

Dem Presidential Candidate Calls For Universal Healthcare, Including Psychedelics Therapy

Marianne Williamson, a 2024 Democratic presidential candidate says the federal government should “fully legalize” medical treatment with psychedelics like psilocybin and MDMA as they have shown both “success in research” and “incredible promise to completely revolutionize mental healthcare.”

Williamson’s statements referred to the fact that certain psychedelic-assisted therapies are “on the verge of FDA clearance” and others “have already been legalized in states like Oregon,” while ketamine is currently available to treat different conditions. Read more HERE.

The Milestone Round

• Mydecine Innovations Group MYCOF has begun trading on the U.K.'s AQSE growth market.

• Read our exclusive series on the need to enhance psychedelic therapy infrastructure and a geospatial tool for data-driven solutions.

• Pioneering hope: Inside the veteran's organization advancing psychedelics reform policy.

• Joe Caltabiano on preparation for legal psychedelics.

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

Psychedelics ETF Weekly Performance

AdvisorShares Psychedelics ETF PSIL opened Monday, October 9 at $1.54, continuing the opening price downtrend as per prior weeks’ numbers of $1.62, $1.68, $1.70 and $1.75.

On Friday 13, it closed at nearly $1.5, also confirming a closing downtrend considering prior weeks at $1.53, $1.61, $1.66 and $1.74.

Week’s highest was near $1.60 on Tuesday 10, slightly below the prior week at $1.64 and also down from prior highest at $1.76, $1.74 and $1.77. 

Week’s lowest was $1.49 on Friday 13, below last week’s at $1.51, and also consistently down from prior lowests at $1.61, $1.62 and $1.71.

The ETF’s yearly price range has again been changed, now set between $2.69 and $1.50 (vs. just last week set at $3.17-$1.51.)

Highest Trading Psychedelics Stocks Friday, Oct. 13 At Close

• GH Research GHRS closed at $8.08, still descending from prior weeks’ closing prices: $8.70, $10.05, $10.33 and $10.50, respectively.

• COMPASS Pathways CMPS closed at $5.99, also confirming a descending trend as per previous closings: $6.88, $7.40, $7.87 and $9.41.

• Mind Medicine (MindMed) MNMD closed at $2.8, down from prior closings at $3.09, $3.13, $3.62 and $4.17.

• Enveric Biosciences ENVB closed at $2.13, a bit behind former closings $2.24, $2.38, $2.28 and $2.22.

• Bright Minds Biosciences DRUG closed at $1.56, up since past week’s closing at $1.47, yet still down from prior weeks’ closings at $1.6, $1.73 and $1.57.

• Silo Pharma SILO closed at $1.51, also below prior weeks’ closings: $1.66, $1.67, $1.79 and $1.85.

• Atai Life Sciences ATAI closed at $1.28, slightly below past week’s $1.39 and closer to prior two Fridays’ at $1.29 and $1.30 and down from the week before that with closing at $1.45.  

• FSD Pharma HUGE closed at $1.15, confirming the slightly descending trend from prior weeks’ closings: $1.2, $1.21, $1.26 and $1.5.

• Incannex Healthcare IXHL closed at $1.00, down from prior weeks’ closings at $1.09, $1.14, $1.18 and $1.40.

• Cybin CYBN closed at almost $0.58, slightly up from the two immediately prior closings ($0.56 and $0.53,) and certainly higher than not-long-ago ones at $0.33.

• Lucy Scientific Discovery LSDI closed at $0.37, almost the same as past Friday’s closing at $0.36, therefore still down from past weeks’ at $0.60, $0.69 and $0.65.