Karuna Therapeutics, Inc. (NASDAQ: KRTX) is engaged as a clinical-stage biopharmaceutical company that is focused on the research and development of innovative therapies for psychiatric and neurological conditions. Shares of the biopharma company are soaring 61% through early trading on Monday, August 8, 2022. Over the past three months, Karuna Therapeutics has seen average daily volume of 314,320 shares. However, volume of 2.86 million shares or dollar volume of around $651.34 million, has already exchanged hands through early trading.

Shares of Karuna Therapeutics are surging after the company announced results from its Phase 3 EMERGENT-2 clinical trial of KarXT, an experimental drug candidate for the treatment of schizophrenia. The trial results showed that the company primary and secondary endpoints were met with statistical significance and KarXT was well tolerated by the testing group.

The primary endpoint was met after KarXT-treated patients reported a meaningful 9.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) compared to the placebo group. Karuna Therapeutics’s secondary endpoints were met after treatment group reported statistically significant reduction in “positive symptoms,” (hallucinations, delusions) and negative symptoms (difficulty enjoying life, withdrawn.)

The clinical trial results are very promising, as it represents a potential new treatment for schizophrenia for the first time in over 50 years. Despite the fact there are existing treatments for schizophrenia, there continues to be an unmet need, as standard treatments simply do not treat all factors of the illness.

“We are thrilled that these topline results from the Phase 3 EMERGENT-2 trial confirm what was seen in our Phase 2 EMERGENT-1 trial and underscore the potential for KarXT, with its novel and unique mechanism of action, to redefine what successful treatment looks like for the 21 million people living with schizophrenia worldwide, and potentially usher in the first new class of medicine for these patients in more than 50 years,” said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. “These results represent our second positive registrational trial. We look forward to continuing to gather long-term safety data to support our submission of a New Drug Application with the U.S. Food and Drug Administration for KarXT as a treatment for schizophrenia, which we expect to occur in mid-2023.”

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