KRTX - Karuna Therapeutics jumps 38% as schizophrenia trial meets key goals

The shares of Karuna Therapeutics ( NASDAQ: KRTX ) surged ~38% in the pre-market on Monday after the clinical-stage biotech announced that its late-stage trial for experimental schizophrenia therapy KarXT met the primary endpoint.

The Phase 3 trial named EMERGENT-2 involved 252 adults with schizophrenia in the U.S. who were randomized 1:1 to receive KarXT (n=126) or placebo (n=126) two times a day (BID) for five weeks.

In terms of Positive and Negative Syndrome Scale (PANSS), KarXT led to a statistically significant and clinically meaningful 9.6-point reduction of the measure, achieving the primary endpoint compared to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001).

In addition, the KarXT impact appeared early and sustained with statistical significance, the company said, noting that the reduction of symptoms measured using PANSS total score, started at Week 2 and the reduction remained across all time points of the trial.

In terms of safety, the experimental therapy was well tolerated and the overall discontinuation rates between KarXT and placebo arms were similar (25% vs. 21%). The incidence of treatment-emergent adverse events stood at 75% and 58%, respectively.

The EMERGENT program consists of five clinical trials including three ongoing studies. Topline data from one such trial called EMERGENT-3 is expected in 1Q 2023.

Karuna ( KRTX ) expects to disclose data from the additional analysis of EMERGENT-2 trial at future medical events.

For further details see: