3 Psychiatry Headlines You Missed in June 2026

June brought regulatory setbacks, psychedelic breakthroughs, and a shifting neuromodulation landscape to psychiatry. Cingulate's once-daily ADHD therapy CTx-1301 hit a manufacturing-related snag at the US Food & Drug Administration (FDA), even as its phase 3 data across both adult and pediatric populations held up. Meanwhile, Definium Therapeutics' DT120 reported topline phase 3 results in treatment-resistant major depressive disorder (MDD), with a single dose producing rapid, durable symptom relief through 12 weeks; investigator John Sonnenberg, PhD, said this was unlike anything he's seen in his career.

Elsewhere, TMS is undergoing its own transformation. Accelerated protocols compressing weeks of treatment into days are matching outcomes from the traditional 6-week course, and the FDA's January clearance of the first at-home neuromodulation device for MDD is opening new access points for patients who have long been shut out of standard care by logistics alone.

From CMC-driven delays to compressed dosing schedules, here are 3 psychiatry stories from June 2026 you may have missed.

FDA Issues CRL for CTx-1301 in ADHD Over Manufacturing Concerns

The FDA issued a complete response letter (CRL) for CTx-1301 (dexmethylphenidate HCl), Cingulate's investigational once-daily ADHD treatment, on June 2, 2026, citing Chemistry, Manufacturing, and Controls (CMC) information requests. The agency raised no concerns regarding clinical safety or efficacy.

The decision follows review of 2 pivotal phase 3 trials. In the adult dose-optimization study, 21 participants titrated to doses between 25 mg and 50 mg met the primary PERMP endpoint, with effect sizes ranging from 0.88 to 2.60. In the pediatric fixed-dose trial, children and adolescents aged 6 to 17 years showed dose-dependent improvements on the ADHD-RS-5, with the 37.5 mg dose producing the largest effect. Safety findings in both trials were consistent with the broader methylphenidate class.

CTx-1301 uses a multi-core tablet designed to deliver 3 timed releases over 12 to 16 hours. Cingulate says CMC work is underway, with resubmission as its immediate priority.

Emerge Phase 3: DT120 Shows Rapid, Durable Relief in MDD

Emerge, a phase 3 trial evaluating a single dose of DT120 (lysergide) ODT 100 µg in adults with MDD (aged 18 – 74 years), met its primary endpoint and all key secondary efficacy endpoints, according to topline results announced by Definium Therapeutics on June 22, 2026.

The 149-patient, placebo-controlled study found a placebo-adjusted MADRS reduction of 8.1 points at week 6 (P <.0001), with a 7.3-point difference persisting at week 12. Sonnenberg told HCPLive the durability of response was more clinically meaningful than the early signal alone. Remission rates reached 24% at week 6 versus 3% for placebo.

DT120 ODT was generally well tolerated, with no serious adverse events or suicidality signals reported. Definium's next phase 3 study, Ascend, will include a low-dose arm to address functional unblinding concerns.

TMS for MDD Is Changing Fast. Here's What Psychiatrists Need to Know

TMS has been FDA-cleared for MDD since 2008, but the standard 36-session, 6-to-8-week protocol has long limited access for patients with treatment-resistant depression. That's beginning to change, according to 3 clinician-researchers: Linda Carpenter, MD (Brown), Andrew Leuchter, MD (UCLA), and Scott Wilke, MD, PhD (UCLA).

A March 2026 analysis found that a 5x5 accelerated rTMS regimen produced efficacy comparable to the conventional 6-week course. Leuchter noted that insurance reimbursement for accelerated protocols remains a gap, as Medicare covers only up to 2 sessions per day.

The FDA also approved Neurolief's ProlivRx in January 2026, the first at-home neuromodulation therapy for MDD. In the MOOD trial, ProlivRx achieved a 21.3% remission rate versus 6.0% for sham (P =.027).

Related: TMS for MDD Reimagined: Faster, Fewer Visits, and Now at Home