London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
Despite missing the primary endpoint in a phase III study of solriamfetol in major depressive disorder, Axsome Therapeutics Inc. still sees a path to another phase III study. It’s a path some analysts and investors are concerned about, though its precision-medicine approach got plenty of nods of approval.
Mood disorders include major depressive disorder and bipolar disorder, and they affect mood and cognition. It is known that mood disorders share a genetic heritable background, but the environmental factors also play a key role here. Recent data had highlighted the potential role of micro RNAs (miRNAs) in the pathogenesis of mood disorders.
Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the non-invasive Sooma 2Gen device in improving MDD as an at-home treatment.
Major depressive disorder (MDD) is a leading cause of disability worldwide and unfortunately no treatment without side effects is available. Previous reports have found unbalanced glutamate-glutamine cycle in the medial prefrontal cortex of mice with depression, which led to the interest in glutamine synthetase as a potential therapeutic target for treating MDD, since this enzyme is a regulator of this cycle.
The J.P. Morgan (JPM) Healthcare Conference in San Francisco kicked off with a resounding bang as Johnson & Johnson (J&J) disclosed plans to acquire Intra-Cellular Therapies Inc. for $132 per share, which equates to an equity value of about $14.6 billion.
Major depressive disorder (MDD) notched another late-stage failure in the form of Neumora Therapeutics Inc.’s data from the phase III Koastal-1 study, the first of three replicant trials in the pivotal program testing kappa opioid receptor antagonist navacaprant.
Shares of Relmada Therapeutics Inc. (NASDAQ:RLMD) plummeted 77% to close at 63 cents Dec. 4 after a pre-planned interim analysis prompted the independent data monitoring committee to conclude the phase III Reliance II study testing REL-1017 in major depressive disorder is likely to fail, leaving the future of the NMDA receptor channel blocker in doubt while the company looks ahead to an earlier-stage psilocybin-based program targeting metabolic disease.
Damona Pharmaceuticals Inc. has obtained IND clearance from the FDA for DPX-101 for the treatment of cognitive deficits in brain disorders, including major depressive disorder.
Despite positive findings from an earlier trial, Alto Neuroscience Inc.’s BDNF-targeting candidate, ALTO-100, failed to best placebo in a phase IIb study in major depressive disorder, sending shares of the company to their lowest price since going public in a February 2024 IPO, as investors worried about readthrough to Alto’s biomarker-based approach for treating psychiatric disorders.
