FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement
Clinical-stage psychedelics biopharma company Cybin Inc. CYBN announced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major Depressive Disorder (MDD.)
It makes the group of psychedelic-based treatments for mental health conditions that have in recent years received such status granted by the U.S. federal agency five therapies total: Cybin’s, MindMed’s MNMD LSD-derived treatment for Generalized Anxiety Disorder, MAPS’ MDMA-assisted therapy for PTSD treatment, Compass Pathways’ CMPS psilocybin therapy targeting Treatment-Resistant Depression (TRD,) and Usona Institute’s psilocybin therapy for MDD as well. READ MORE.
MindMed Receives FDA ‘Breakthrough Therapy’ Designation For LSD As Anxiety Treatment, Shares Positive Results About Related Clinical Trials And Expected $175M Proceeds
Mind Medicine (MindMed) announced that the FDA has granted the “breakthrough therapy” designation to its MM120 (lysergide d-tartrate) program for the treatment of Generalized Anxiety Disorder (GAD).
The company stated that, based on the significant unmet medical need in the treatment of GAD, especially in patients who do not respond to or tolerate currently available medications, this news as well as initial clinical data from other research, the FDA has designated MM120 for GAD as a breakthrough therapy. READ MORE.
Shortly following the news, the company announced the pricing of an underwritten offering of 16,666,667 common shares, no par value per share, at an offering price of $6.00 each. It has also entered into share purchase agreements for a concurrent private placement of 12,500,000 common shares.
Total gross proceeds, from the underwritten offering and the concurrent private placement are expected to be around $175 million. READ MORE.
Fed Agency Grants $14M To Gilgamesh For Cardiac-Safe Ibogaine Analog Targeting Opioid Use Disorder
Clinical-stage neuroscience company Gilgamesh Pharmaceuticals has been awarded a multi-year $14 million grant from the National Institute on Drug Abuse (NIDA) to develop GM-3009, a novel, reportedly cardiac-safe ibogaine analog for the treatment of substance use disorders.
As recently reported in the York Times, the plant-derived psychoactive compound ibogaine holds accumulated data from trials and case reports that point to its robust efficacy as a treatment for substance use disorders. READ MORE.
Indiana Governor Signs Health Bill Including State Funds For Psilocybin Research
Indiana Gov. Eric J. Holcomb (R) acted swiftly on the passing of a health bill, which includes provisions to fund clinical research trials into psilocybin. Sent by the state legislators to his desk on March 12, the governor officially signed the proposal into law the following day, March 13.
The bill, HB 1259, with final amendments adding the psychedelics language – originally SB 139 passed the Senate and the House’s Public Health committee – received the green light from both state chambers on March 12. READ MORE.
The Milestone Round
See Also: Prior Edition Of ‘Psyched’
Psychedelics ETF’s Weekly Performance
AdvisorShares Psychedelics ETF PSIL opened Monday, March 18 at $1.50, following prior openings at $1.65, $1.58, and $1.46 (March 11, 4 and Feb. 26, respectively.)
On Friday, March 15 it closed at $1.53, following prior closings at $1.64, $1.57 and $1.41 (March 8, 1 and Feb. 23, respectively.)
Last week’s highest was $1.65, at Tuesday, March 12 closing. Prior weeks’ highests were $1.78, $1.57 and $1.52.
Week’s lowest was $1.46 at several points during the week. Prior weeks’ lowests were $1.44, $1.43 and $1.41.
Highest Trading Psychedelics Stocks Friday, March 15 Close
- GH Research GHRS closed at $10.91, sustaining the upper trend as per prior weekly closings at $8.08, $8.50 and $7.51 (March 8, 1 and Feb. 23, respectively.)
- COMPASS Pathways closed at $9.90, down from prior closings at $10.88, $11.47 and $10.20.
- Mind Medicine (MindMed) closed at $9.10, still jumping as per prior closings at $9.10, slightly behind the immediate prior week’s closing at $9.50 yet still way high as from two and three weeks past closings at $6.21 and $4.91.
- Incannex Healthcare IXHL closed at $3.25, dropping from prior closings at $4.20, $5.37 and $4.84.
- Silo Pharma SILO closed at $1.84, still up from prior closings at $1.61, $1.59 and $1.57.
- Atai Life Sciences ATAI closed at $1.75, also dropping from prior weekly closings at $2.11, $2.14 and $1.83.
- Bright Minds Biosciences DRUG closed at $1.31, still within the decreasing trend as per prior closings at $1.58, $1.76 and $1.88.
- Clearmind Medicine CMND closed at $1.27, also still falling from prior closings at $1.38, $1.60 and $1.81.
- Lucy Scientific LSDI closed at $1.25, following closings at $1.70, $1.91 and $2.42.
- Enveric Biosciences ENVB closed at $1.07, following closings at $1.46, $1.62 and $0.95.
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