Alkermes launches a phase 2 trial of oral orexin-2 agonist ALKS 7290 to boost antidepressant response in major depressive disorder, assessing safety and symptom relief.

Minerva Neurosciences webinar reported that roluperidone monotherapy improved primary negative symptoms and functioning in stable patients with schizophrenia who had a low relapse risk.

Cingulate shares plans to resubmit its ADHD candidate CTx-1301 to the FDA, following a CRL tied to CMC information requests

Compass Pathways has completed its submission of an NDA to the FDA for COMP360 psilocybin for treatment-resistant depression.

GLP-1 drugs enter psychiatry, curbing antipsychotic weight gain while raising new questions about addiction, mood, eating disorders, and culture.

Sabirnetug phase 2 Alzheimer trial misses cognitive endpoint despite lowering amyloid, prompting Acumen to halt development and open-label extension plans.

Neflamapimod misses its main DLB endpoint, but biomarker and subgroup signals suggest IL-1β pathway impact and may justify a phase 3 trial.

The FDA seems to have shelved the fast-track drug review initiative launched during the Trump administration.