MNMD - MindMed Receives FDA 'Breakthrough Therapy' Designation For LSD As Anxiety Treatment Shares Positive Results About Related Clinical Trials | Benzinga
Mind Medicine (MindMed) (NASDAQ:MNMD) 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 clinical-stage psychedelics biotech firm will now join industry counterparts Lykos Therapeutics (formerly MAPS PBC) and Compass Pathways (NASDAQ:CMPS), who also obtained the FDA’s for MDMA-assisted therapy to treat PTSD and psilocybin-assisted therapy for treatment-resistant depression (TRD).
The company announced 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.
"The FDA's decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provides further validation of the important potential role this treatment can play in addressing the huge unmet need ...