Definium Says DT120 Receives FDA Breakthrough Therapy Designation in Major Depressive Disorder

08:09 AM EDT, 09/08/2026 (MT Newswires) -- Definium Therapeutics (DFTX) said Tuesday that the US Food and Drug Administration has granted breakthrough therapy designation to DT120 orally disintegrating tablet in major depressive disorder. The designation was supported by results from a phase 3 trial, the company said. This is the second FDA breakthrough therapy designation for DT120, Definium's formulation of lysergide, following its initial designation for generalized anxiety disorder, the company said. Shares of the company were 3.6% higher in Tuesday premarket activity.