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Definium Therapeutics Receives FDA Breakthrough Therapy Designation (BTD) for DT120 in MDD

Shots: Definium Therapeutics announced that the US FDA granted BTD to DT120 (lysergide) orally disintegrating tablet (ODT) for the treatment of major depressive disorder (MDD), following positive P-III results In the P-III Emerge study, a single 100 µg dose of DT120 ODT demonstrated an 8.1-point PBO-adjusted improvement in MADRS total score at wk. 6 (p<0.0001),…

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Definium Therapeutics Reports P-III (Voyage) Study on DT120 ODT in Generalized Anxiety Disorder (GAD)

Shots: Definium has reported topline P-III (Voyage) trial results assessing DT120 (lysergide, Orally Disintegrating Tablet, 100µg; n=107) vs PBO (n=107) in 214 adults with GAD Voyage met its 1EP, with DT120 improving HAM-A scores at Wk. 12 (-11.6 vs -6.2). Efficacy emerged by Day 2 & was sustained through all post-baseline timepoints in Part A Key…

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