Why Is Incannex Healthcare Stock Surging Today?

Incannex Healthcare Inc. (IXHL) on Tuesday announced positive data from a mid-stage trial evaluating PSX-001 for Generalised Anxiety Disorder (GAD). The stock shot up nearly 15% in Tuesday’s pre-market session.

The company said that the results from the trial confirm statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, including on the Hamilton Anxiety Rating Scale. The trial enrolled 73 adult participants diagnosed with moderate to severe Generalised Anxiety Disorder.

On Stocktwits, retail sentiment around IXHL stock jumped from ‘bearish’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.

PSX-001, also called Psi-GAD, is a psilocybin-assisted psychotherapy treatment. Patients treated with PSX-001 in the study achieved an average 12.8-point reduction in Hamilton Anxiety Rating Scale scores from baseline, compared to a 3.6-point decrease in the placebo group. This difference was statistically significant and sustained across the 11-week follow-up period, the company said.

Of patients receiving treatment, 27% achieved full disease remission, five times higher than placebo. Quality of life also improved by an average of 10.6 points on the Personal Wellbeing Index in the PSX-001 group versus 2.7 points for placebo. “Psi-GAD demonstrated a reduction in anxiety, improved mood, enhanced quality of life, and better day-to-day functioning. Importantly, the treatment effect was durable and observed across 11 weeks,” said Lou Barbato, Chief Medical Officer of Incannex.

The company is now preparing to initiate a multi-jurisdiction mid-stage clinical trial. Incannex is also exploring strategic partnerships to accelerate development and broaden global access to PSX-001.

Treatment with Psi-GAD was well tolerated across the study population, the company said. The majority of treatment-emergent adverse events (TEAEs) were transient, mild to moderate in nature, and consistent with the expected pharmacological effects of Psilocybin, the company said. It added that there were no signs of concerns often cited with psychedelic treatments, such as increased suicidality, psychosis, or prolonged psychological distress. However, one subject withdrew from the trial, Incannex said. 

IXHL stock is down by 65% this year and by 61% over the past 12 months. 

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