This morning, Irish 5-MeO-DMT drug developer GH Research shared topline data from its Phase 2b study of GH001 in treatment-resistant depression (TRD). The readout has been well-received by psychedelics insiders and investors alike, with the company’s marketcap once again entering billion-dollar territory as shares in the company doubled over the past few days.

In its announcement, the company revealed that the study met its primary endpoint, with a placebo-adjusted MADRS reduction from baseline of -15.5 at day 8 and 57.5% of patients in the GH001 arm in remission at day 8 compared to 0% in the placebo group.

The company also announced that all secondary endpoints were met, and that the drug was well tolerated with no serious adverse events reported in the study thus far, including no evidence of treatment-emergent suicidal ideation or behaviour.

Despite a positive readout, questions remain around the program including an apparent nocebo response among those in the placebo arm, the FDA’s clinical hold on the company’s U.S. development, and the intellectual property landscape surrounding its investigational drug product.

Here, we take a closer look at the study’s design, today’s topline efficacy and safety readout, the commercial case for GH001, and the path ahead for the company…