The Week of

GH Research announced that the FDA lifted the clinical hold on its lead experimental depression treatment, GH001. With that, the company can now move forward with late-stage clinical development and prepare for a global Phase 3 trial in 2026. 

GH001, an inhaled form of 5-MeO-DMT, is being tested as a potential therapy for treatment-resistant depression. This regulatory clearance removes a major hurdle that had paused U.S. testing. Here’s more: https://investor.ghres.com/news-releases/news-release-details/gh-research-announces-fda-lifts-clinical-hold-gh001-clearing

Compass Pathways announced that the FDA accepted its Investigational New Drug (IND) application for COMP360, enabling clinical development of the company’s proprietary, synthetic psilocybin formulation for the treatment of PTSD. 

This milestone expands the COMP360 development program beyond treatment-resistant depression and reflects the company’s strategy to establish a multi-indication psychedelic-assisted therapy platform targeting serious neuropsychiatric disorders with high unmet need. 

Advancement into PTSD positions the company to leverage existing clinical infrastructure and regulatory experience as it progresses toward late-stage trials. Check it out: https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Announces-FDA-Acceptance-of-IND-Application-for-PTSD-and-Hosts-Webinar-on-PTSD-and-TRD/default.aspx

Eli Lilly agreed to acquire Ventyx Biosciences for approximately $1.2 billion, adding a set of inflammation-targeting assets with potential relevance to neurodegenerative diseases, including Parkinson’s. 

A key driver of the deal is Ventyx’s oral NLRP3 inflammasome inhibitors, which are designed to suppress chronic neuroinflammation – a biological process increasingly implicated in the progression of Parkinson’s and other neurodegenerative disorders.

Recent clinical and biomarker readouts have strengthened the case that modulating NLRP3-driven inflammation may influence disease-relevant pathways in the brain, helping explain Lilly’s interest in bringing the platform in-house. 

This acquisition expands Lilly’s neuroscience and neuroinflammation footprint beyond symptomatic treatments, positioning the company to pursue disease-modifying approaches that target upstream inflammatory mechanisms believed to contribute to neuronal damage and degeneration. Here’s more: https://www.fiercebiotech.com/biotech/lilly-buys-inflammation-biotech-venytx-12b-wake-parkinsons-cardiovascular-readouts

Did you know that researchers at Johns Hopkins launched an online course titled “Psychedelic Science and Medicine” to provide a rigorous, evidence-based overview of psychedelic compounds and their role in medicine and neuroscience?

The class covers the history of psychedelics, results from clinical trials, underlying brain mechanisms, and ethical and societal issues, with instruction from faculty members actively involved in leading psychedelic research. 

The course is intended to help clinicians, scientists, and the general public understand the scientific context and risks associated with psychedelics, as well as their potential therapeutic applications for conditions such as depression, substance use disorders, and existential distress. Check it out: https://www.coursera.org/learn/psychedelic-science-and-medicine