5 Psychiatry Headlines You Missed in February 2026

February 2026 brought a series of notable developments in psychiatry, spanning regulatory approvals, late-stage clinical trial milestones, and new research aimed at improving care for patients with complex mood disorders. From advances in psychedelic-assisted therapies to new pharmacologic options for serious mental illness, the month highlighted the evolving treatment landscape for conditions such as schizophrenia, bipolar disorder, and major depressive disorder.

Among the most significant updates was the approval of milsaperidone (Bysanti) by the US Food and Drug Administration (FDA) for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults, expanding the range of first-line treatment options available to clinicians. Meanwhile, investigational psychedelic therapies continued to generate momentum, with COMP360 psilocybin meeting the primary endpoint in a second phase 3 trial for treatment-resistant depression and early clinical data suggesting antidepressant effects from intravenous SPL026 in patients with major depressive disorder.

Beyond drug development, new research also offered insights into clinical decision-making and emerging neuromodulation approaches. Studies examining predictors of relapse following antidepressant discontinuation and the age-related effects of magnetic seizure therapy in treatment-resistant depression underscore the ongoing effort to refine personalized care strategies for patients with difficult-to-treat psychiatric conditions.

In this psychiatry month in review, we highlight the key approvals, clinical trial updates, and research findings that shaped the month of February.

FDA Approves Milsaperidone for Acute Bipolar I Disorder, Schizophrenia

On February 20, 2026, the FDA approved Vanda Pharmaceuticals’ milsaperidone (Bysanti) tablets as a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. In clinical studies, milsaperidone demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum. Commercial availability is expected by Q3 2026.

Intravenous DMT (SPL026) Demonstrates Significant MDD Reduction in Phase 2a Trial

On February 20, 2026, Helus Pharma announced the publication of results from a phase 2a randomized, placebo-controlled clinical trial evaluating SPL026 in participants with moderate-to-severe major depressive disorder. The study met its primary endpoint for statistically significant and clinically meaningful reductions in depressive symptoms at 2 weeks, as measured by the Montgomery-Åsberg Depression Rating Scale in participants treated with SPL026 compared with placebo. Helus Pharma does not plan to advance intravenous SPL026 in its current form but will use the mechanistic and clinical insights generated from the trial to continue to inform the Company’s HLP004 development program.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

On February 17, 2026, Compass Pathways announced that its investigational synthetic psilocybin formulation, COMP360, met the primary endpoint in the second pivotal phase 3 trial evaluating the therapy in adults with treatment-resistant depression. In the COMP006 study, a pair of 25-mg doses administered 3 weeks apart yielded a statistically significant reduction in depressive symptom severity at week 6 compared with a 1-mg dose control, reinforcing findings from the companion COMP005 trial and advancing the program toward regulatory submission.

Delay Discounting Fails to Predict MDD Relapse, Q&A With Giles Story, PhD

Recent research shows delay discounting did not predict relapse after antidepressant discontinuation in patients with remitted major depressive disorder, despite a modest association with residual depressive symptoms. Findings from the multi-site longitudinal study suggest a lack of reliable tools for predicting relapse and emphasize the importance of individualized, shared decision-making when counseling patients.

MST Shows Age-Related Differences in MDD Outcomes, With Lina Jia, MD, PhD

New data suggest adolescents with treatment-resistant major depressive disorder receiving magnetic seizure therapy (MST) may experience faster symptom improvement, fewer cognitive adverse events, and better overall tolerability compared to adults. Findings from the prospective comparative study address a critical evidence gap in neuromodulation for depression, as most existing data are derived from adult populations despite important developmental, neurobiological, and safety considerations in younger patients.