The Week of

Atai Beckley announced it received clearance to advance BPL-003 into Phase 3 trials. This is a major step toward potential approval of its intranasal 5-MeO-DMT therapy for treatment-resistant depression. 

If clinical trials are successful, BPL-003’s short-acting design could make psychedelic-assisted therapy far more scalable within traditional healthcare systems. While Phase 3 trials remain complex and risky, the clearance places Atai Beckley among a small group of companies pushing psychedelic treatments toward real pharmaceutical commercialization. Here’s more: https://substack.com/home/post/p-189832125

Vanda Pharmaceuticals announced that the FDA granted a formal evidentiary public hearing to review the agency’s proposed refusal to approve HETLIOZ® (tasimelteon) for the treatment of jet lag disorder. 

The decision is highly unusual (potentially the first drug approval hearing of its kind in more than 40 years) and follows a court ruling that required the FDA to consider Vanda’s clinical evidence more fully. 

HETLIOZ is already approved for certain circadian rhythm disorders, and the company is seeking to expand its label to treat jet lag, a condition affecting millions of travelers worldwide with no FDA-approved prescription therapy currently available. Check it out: https://vandapharmaceuticalsinc.gcs-web.com/node/16831/pdf

BrainSight announced new clinical data validating its SWIFT® Deep TMS system as a potential breakthrough in the treatment of depression.

The data support the safety and efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS), reinforcing its potential role as an alternative to or alongside traditional antidepressant approaches. 

As treatment-resistant depression continues to challenge patients and clinicians, these findings could help expand the adoption of non-pharmacologic neuromodulation therapies and influence future standards of care. Here’s more: https://www.brainsway.com/news_events/landmark-data-validate-brainsways-swift-deep-tms-beginning-a-new-era-in-depression-treatment/

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Did you know that drinking coffee or tea could potentially lower your risk of dementia?

Researchers analyzing data from more than 130,000 participants followed for up to 43 years found that people who consumed moderate amounts of caffeinated coffee or tea had a lower risk of developing dementia and showed slightly better cognitive function over time. 

The strongest association appeared among those drinking about two to three cups of coffee a day or one to two cups of tea, while decaffeinated coffee showed no similar link. Scientists caution, of course, that the findings show an association rather than proof of cause, but the results add to growing evidence that moderate caffeine intake could play a role in long-term brain health. Check it out: https://www.rte.ie/news/health/2026/0304/1561588-study-caffeine-dementia/