Morning Rounds: News from April 20-26

Pharmaceutical Updates

FDA Fast-Tracks Psychedelics for Depression and PTSD with Priority Vouchers

Following a presidential executive order signed April 18, the US Food and Drug Administration (FDA) announced on April 24 a group of regulatory actions to accelerate psychedelic therapies for serious mental illness.¹ The agency issued National Priority Vouchers to 3 companies—Compass Pathways (psilocybin for treatment-resistant depression), Usona Institute (psilocybin for major depressive disorder), and Transcend Therapeutics (methylone for posttraumatic stress disorder)—compressing review timelines and reinforcing federal support for this drug class. The FDA simultaneously cleared the first US clinical study of noribogaine hydrochloride, an ibogaine derivative, for alcohol use disorder. The agency also announced that final guidance for designing serotonin-2A agonist clinical trials is imminent.

For more information on psychedelics in psychiatry, read Psychiatric Times’ Psychedelics Special Report.

Pharmaceutical Updates

AXS-05 (Auvelity) FDA Decision Due April 30—Would Become First Approved for Alzheimer Disease Agitation

The FDA's PDUFA target action date for Axsome Therapeutics' supplemental NDA for AXS-05 (dextromethorphan/bupropion) in Alzheimer disease agitation is April 30, 2026.² The drug, already approved as Auvelity for MDD, was granted Breakthrough Therapy designation for this indication in 2020 and Priority Review status in December 2025. The sNDA is backed by 4 randomized, double-blind phase 3 trials and a long-term safety study, all demonstrating statistically significant reductions in agitation symptoms versus placebo. Agitation affects an estimated 76% of patients with Alzheimer disease and is one of the most clinically challenging symptoms to manage, currently addressed only off-label with antipsychotics that carry notable risk profiles in elderly patients.

Pharmaceutical Updates

Oral R-MDMA (EMP-01) Cuts Social Anxiety Symptoms by 38% in Phase 2a Data

AtaiBeckley announced April 22 that expanded phase 2a results for EMP-01, an oral, single-enantiomer formulation of R-MDMA, demonstrated clinically meaningful and consistent improvements across all major outcome measures in adults with social anxiety disorder.³ Participants received just 2 in-clinic doses of EMP-01 (225 mg) 28 days apart with no adjunctive psychotherapy, achieving an 11.9-point reduction on the Liebowitz Social Anxiety Scale and a 38% reduction on the Social Phobia Inventory vs 15% on placebo at Day 43. No serious adverse events, excessive sedation, or treatment-emergent suicidal behavior were observed, addressing a key concern that has surrounded MDMA-based therapies since the FDA's 2024 rejection of racemic MDMA for PTSD. Social anxiety disorder has seen no novel approved mechanism in over 20 years, making a well-tolerated, episodic-dosing psychedelic candidate a potentially significant development.

Policy & Legislation

Bill Would Abolish Medicare 190-Day Lifetime Cap on Inpatient Psychiatric Care

As conversations continue around a Senate bill introduced in March, clinicians should be aware of potential changes in legislation for inpatient care. Senate bill S.4076 (the Removing Medicare Mental Health Inpatient Limitations Act of 2026) would eliminate the 190-day lifetime limit on Medicare coverage of inpatient psychiatric hospital services, a restriction that applies to freestanding psychiatric facilities but not general medical hospitals.⁴ The bill has bipartisan support and a companion House bill (H.R.4619), and a coalition of over 359 disability and aging organizations sent a letter to Congress in early April urging passage. The 190-day cap, originating in a 1965 Medicare law, has long been cited as a structural inequity that limits access to intensive psychiatric care for the most severely ill Medicare patients simply because they require extended hospitalization. If passed, the legislation would expand access to longer psychiatric stays for Medicare beneficiaries, and this policy change is actively moving through Congress.

Clinical Research

Review Finds Lack of Efficacy of Monoclonal Antibodies in Alzheimer Disease, Authors Publish Response Critiquing the Review’s Methods

A major systematic review was published April 16, analyzing 17 randomized controlled trials involving over 20,000 participants, and concluded that the entire class of amyloid-beta–targeting monoclonal antibodies—including lecanemab and donanemab—produces little to no meaningful difference in cognitive function or dementia severity at 18 months.⁵ The review covered 9 agents and found the effect on functional ability to be "small at best," while positing that these drugs reliably increase the risk of amyloid-related imaging abnormalities. The authors recommend that future Alzheimer disease research pivot away from amyloid clearance toward other mechanisms such as tau, neuroinflammation, and metabolic pathways.

A response was published April 23 in The Lancet which stated the review’s results were undermined by the methodology used.⁶ The review pooled 5 failed first-generation amyloid antibodies (aducanumab, bapineuzumab, crenezumab, gantenerumab, solanezumab) alongside 2 agents (lecanemab and donanemab) that have cleared phase 3 and received regulatory approval. Authors contend this aggregation turns therapeutic progress into statistical noise, obscuring the modest but meaningful benefit that both regulators and independent experts have attributed to the approved agents. The UK Dementia Research Institute and the Alzheimer's Society have issued parallel statements supporting this critique.⁷

References

1. Duerr HA. FDA fast-tracks psychedelic therapies for depression, PTSD, and alcohol use disorder. Psychiatric Times. April 24, 2026. https://www.psychiatrictimes.com/view/fda-fast-tracks-psychedelic-therapies-for-depression-ptsd-and-alcohol-use-disorder

2. Jennings S. FDA grants priority review to AXS-05 for agitation in Alzheimer disease, sets April 2026 PDUFA Date. Patient Care. January 2, 2026. Accessed April 26, 2026. https://www.patientcareonline.com/view/fda-grants-priority-review-to-axs-05-for-agitation-in-alzheimer-disease-sets-april-2026-pdufa-date

3. Kuntz L. EMP-01 for social anxiety disorder demonstrates meaningful improvements in phase 2a study. Psychiatric Times. April 22, 2026. https://www.psychiatrictimes.com/view/emp-01-for-social-anxiety-disorder-demonstrates-meaningful-improvements-in-phase-2a-study

4. S.4076 - Removing Medicare Mental Health Inpatient Limitations Act of 2026. Congress.gov. 2026. https://www.congress.gov/bill/119th-congress/senate-bill/4076/text/is

5. Nonino F, Minozzi S, Sambati L, et al. Amyloid‐beta‐targeting monoclonal antibodies for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Cochrane. 2026.

6. Fox NC, Kohlhaas S, Schott JM. Alzheimer's disease immunotherapy and the amyloid hypothesis: when aggregation obscures interpretation. Lancet. 2026.

7. Oakley R. Alzheimer's Society and leading experts respond to claims anti-amyloid drugs are ineffective. Alzheimer’s Society. April 21, 2026. Accessed April 26, 2026. https://www.alzheimers.org.uk/blog/alzheimers-society-and-leading-experts-respond-claims-anti-amyloid-drugs-are-ineffective