Psyched: LSD, Psilocybin As Breakthrough Therapies, $14M Fed Grant For Ibogaine, Indiana’s Research And More
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. (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.
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 …