Depymed Inc. has received FDA clearance to initiate a phase I trial for DPM-1003 for the treatment of Rett syndrome.

Precision psychiatry got some love at two quite different meetings this week, the European Congress of Neuropsychopharmacology’s New Frontiers meeting and BioEurope Spring. The New Frontiers Meeting, an annual two-day meeting dedicated to cutting-edge issues in brain disease research, focused on big-picture and scientific – at times almost philosophical – questions of how to get to a classification scheme for brain disorders that aligns with the underlying biology.

To Steve Hyman, the manual that clinicians currently use to diagnose mental disorders is an active obstacle to getting a scientific understanding of those disorders. Hyman, who is director of the Stanley Center for Psychiatric Research at the Broad Institute, MIT and Harvard, and a former director of the National Institute of Mental Health (NIMH), listed multiple weaknesses of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM), whose diagnoses, he said, are “arbitrary, rigid, life-stage and context-insensitive,” as well as blind to the fact that mental disorders exist along a continuum.

At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.

Patients with amyotrophic lateral sclerosis (ALS) have a median survival of 2 to 5 years. There are 3 FDA-approved drugs for ALS (riluzole, edaravone and Relyvrio [phenylbuturate/taurursodiol]), but they only lead to modest benefit. There are several pathways involved in the disease, but all of them lead to neuroinflammation.

In 2023, the BioWorld Neurological Diseases Index (BNDI) closed with a 4.36% increase, outperforming the Nasdaq Biotechnology Index (up 3.74%) but falling short of the surge seen in the Dow Jones Industrial Average (up 13.7%). The rebound marked a significant turnaround from November, when BNDI recorded an 18.37% year-to-date decline.

Sooma Oy recently raised €5 million (US$5.4 million) in funding to help the company expand access to its transcranial direct current stimulation device which allows patients to treat their depression at home. “This is a significant milestone for us that enables us to help more patients globally and help us develop the company to serve the unmet need,” Tuomas Neuvonen, Sooma's co-founder and CEO, told BioWorld.