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NEWS

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),…
September 8, 2026

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Axsome
NEWS

Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)

Shots: Axsome reported topline data of PoC P-III (PARADIGM) trial assessing solriamfetol (300mg) vs PBO in MDD pts with severe EDS (ESS ≥16; n=51) & those without severe EDS (n=295) Trial showed no significant MADRS total score change (1EP) in the overall population. However, EDS pts saw depressive symptom improvements across MADRS total score, MADRS…
April 2, 2025

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VIEWPOINTS_Robert Barrow_2023
VIEWPOINTS

MindMed’s CEO Robert Barrow Discusses Positive P-II Trial Data of Lysergide for Major Depressive Disorder

Shots: Robert spoke about the topline data from the P-II study evaluating Lysergide. The data was unleashed by MindMed collaborators at the University Hospital Basel and the University Hospital of Psychiatry The data demonstrated significant, rapid, durable and beneficial effects of Lysergide and its potential to mitigate symptoms of MDD.  He also discussed how these…
August 29, 2023

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