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Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE: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 (NASDAQ:MNMD) LSD-derived treatment for Generalized Anxiety Disorder, MAPS’ MDMA-assisted therapy for PTSD treatment, Compass Pathways’ (NASDAQ:CMPS) psilocybin therapy targeting Treatment-Resistant Depression (TRD,) and Usona Institute's psilocybin therapy for MDD as well. READ MORE.
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.
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 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.
See Also: Prior Edition Of ‘Psyched'
AdvisorShares Psychedelics ETF (NYSE: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.
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Posted In: ATAI CMND CMPS CYBN DRUG ENVB GHRS IXHL LSDI MNMD PBM PSIL SILO TRUFF