Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology

IntroductionLecanemab is a monoclonal antibody targeting amyloid-beta (Aβ) approved for treating Alzheimer’s disease (AD) with mild cognitive impairment or mild dementia. Continuous monitoring of its real-world safety profile remains essential. This study aimed to analyze lecanemab-related adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) database and a multicenter cohort, and explored mechanisms via network pharmacology.MethodsWe conducted an updated disproportionality analysis of FAERS data from 2023 to 2024 to identify disproportionate reporting signals (SDRs). A multicenter retrospective cohort study was performed, including lecanemab users from June 2024 to February 2025. Data were collected from electronic medical records of five tertiary hospitals. AEs were identified and influencing factors of AE occurrence were analyzed. Additionally, a drug-gene interaction network was constructed to explore potential mechanisms.ResultsIn the FAERS analysis of 2,764 AEs from 1,389 lecanemab users, 12 of 41 positive SDRs were prioritized, with 75% (9/12) being nervous system disorders, primarily amyloid-related imaging abnormalities (ARIA). In the cohort study, 29.05% (43/148) of patients experienced AEs, with infusion-related reactions being most common. Age was identified as a risk factor for AE occurrence [OR (95% CI): 1.109 (1.011–1.215), P = 0.028], while pre-treatment significantly reduced AE incidence. Gene enrichment analysis suggested potential links between lecanemab-related genes and AEs.DiscussionThis study provides real-world evidence on the risk profile of lecanemab, highlighting the importance of continued safety monitoring. These findings may inform discussions about the risks associated with anti-amyloid treatments and warrant further confirmation in large-scale prospective studies.

Cognitive-attitudinal factors predict CBT-I enrollment willingness in Chinese sleep clinic patients: a knowledge-attitudes-practices survey

BackgroundDespite strong evidence for cognitive behavioral therapy for insomnia (CBT-I), uptake remains constrained by poorly understood cognitive, attitudinal, and practical barriers. This study examined determinants of willingness to enroll in sleep improvement programs among adults at risk of sleep disorders—including insomnia, obstructive sleep apnea, and comorbid psychological distress—attending a tertiary sleep clinic in China.MethodsA cross-sectional knowledge-attitudes-practices survey was conducted among 2,661 adults attending the sleep and behavioral medicine outpatient clinic at Ganzhou Hospital-Nanfang Hospital, Southern Medical University, Ganzhou, Jiangxi, China, between February 2022 and June 2025. Willingness to enroll in a structured sleep improvement program was assessed alongside sleep health knowledge, perceived need, CBT-I versus medication effectiveness beliefs, telehealth acceptability, clinical severity (Insomnia Severity Index, Epworth Sleepiness Scale, STOP-Bang), psychological symptoms (PHQ-2, GAD-2), perceived barriers, and sociodemographic characteristics. Multivariable logistic regression identified independent predictors of willingness to enrollment, with secondary analyses evaluating model discrimination and testing prespecified interactions.ResultsAmong 2,661 participants (median age 45 years, 56.5% female, median ISI = 13), 1,386 (52.1%) expressed willingness to enroll. Univariable comparisons showed no significant differences between willing and not-willing groups across demographics, clinical characteristics, or barriers (all p>0.05). However, multivariable modeling revealed that when considered simultaneously, cognitive-attitudinal factors emerged as significant independent predictors, suggesting complex interactions rather than simple bivariate associations. In multivariable models, perceived need (OR = 1.20, 95% CI: 1.16–1.25, p<0.001), beliefs that CBT-I is more effective and durable than sleep medication (OR = 1.12, 95% CI: 1.08–1.16, p<0.001), sleep health and treatment knowledge (assessed by a six-item knowledge score) (OR = 1.09, 95% CI: 1.05–1.13, p<0.001), and anxiety symptoms (OR = 1.07, p=0.005) positively predicted willingness. Paradoxically, depression symptoms (OR = 0.94, p<0.001) and insomnia severity (OR = 0.93, p<0.001) inversely predicted willingness. Model discrimination was modest (AUC = 0.543, 95% CI: 0.504–0.590). Time (mean 3.54) and cost (3.44) were most severe barriers but showed no independent association with willingness (p>0.05).ConclusionCognitive-attitudinal factors (perceived need, CBT-I beliefs, knowledge) independently predicted enrollment willingness, whereas demographics and practical barriers did not. Depression and insomnia severity paradoxically reduced willingness, creating an inverse care law. However, poor model discrimination and measurement of stated willingness rather than actual enrollment limit conclusions. Prospective validation and motivational enhancement strategies for patients with depression are needed.

Affordable centimeter-scale 3D microscopy with submicrometer resolution

Nature Biotechnology, Published online: 22 June 2026; doi:10.1038/s41587-026-03209-x

Submicrometer-resolution three-dimensional (3D) imaging of large samples has been constrained by the short working distance, high cost and inflexible design of immersion objectives. We developed hybrid solid–liquid optics (HySIL) — a refractive framework with index-matched components — for submicrometer-resolution 3D imaging of centimeter-scale samples in various immersion media using inexpensive air objectives.

STAT+: AbbVie to buy Apogee Therapeutics in nearly $11B deal

AbbVie on Monday said it would buy Apogee Therapeutics, the developer of immunology drugs, for $10.9 billion in cash, continuing a run in which pharma companies have been scooping up biotechs.

The deal values Apogee at $135.11 per share, a roughly 50% premium on its previous closing price. The Financial Times reported last week the deal was in the works. 

Apogee’s lead drug, called zumilokibart, could be a long-lasting option for patients with a range of inflammatory diseases. It’s being tested in atopic dermatitis and, in combination with another experimental medicine, in asthma. The drug, which targets an inflammatory cytokine called IL-13 that drives a number of conditions, could be given to patients just two to four times a year after they start treatment. 

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STAT+: Definium LSD therapy helped patients with major depression in late-stage trial

Definium Therapeutics said Monday that its LSD therapy significantly helped patients with major depression in its first Phase 3 trial, bringing the psychedelic drug closer to a potential approval.

Six weeks after a single dose, patients on the pill, called DT120, experienced a 13.3-point drop on a depression test called the Montgomery-Åsberg Depression Rating Scale (MADRS), compared with a 5.2-point drop among patients taking placebo.

By 12 weeks, the effect waned a bit but was largely maintained, as patients on the pill had an 11-point drop from their baseline, compared with a 3.6-point drop in the placebo group.

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STAT+: FDA reverses course on Regenxbio’s childhood gene therapy after rejection

The Food and Drug Administration will reconsider approving an experimental gene therapy for a deadly and rare childhood brain disorder that it rejected just four months ago, the therapy’s developer, Regenxbio, said on Monday. 

The sudden turnaround is the latest in a series of apparent FDA reversals in the past two months, after leaders installed by the Trump administration resigned or were fired. Just last week, UniQure announced it was cleared to submit an application for a Huntington’s disease gene therapy that the agency had previously spurned and that former commissioner Marty Makary appeared to disparage on national television.

In Regenxbio’s case, the company had applied for approval for a gene therapy for mucopolysaccharidosis type II, also known as MPS II or Hunter syndrome. An enzyme-replacement therapy has long been available for MPS II, but the enzyme can’t enter the brain, so children with the neurological form of the disease experience progressive cognitive decline. 

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STAT+: Pharma goes on a spending spree, snapping up biotechs in a hurry

Pharmaceutical companies are hungry to make deals, and they’re making more than they have in years. 

In the past six months, there have been 32 biotech acquisitions valued at $1 billion or more. Pharmaceutical companies and even some large biotech companies have spent around $123 billion on these deals.

They’ve blown past last year’s totals in roughly half the amount of time. Pharma companies struck 26 blockbuster M&A deals in 2025, spending $112 billion altogether. 

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