New data from
on the treatment of schizophrenia, KarXT boosted biotech shares more than 60% as analysts said the results were strong enough that the drug could be the treatment of choice once approved.
Investors expected a 7 or 8 point difference between the study group and people who took a placebo in reducing symptoms of schizophrenia, as measured by a tool known as the Syndrome Scale. positive and negative, according to a note released Monday by analyst Mizuho Uy Oreille.
Karuna (KRTX) reported a difference of 9.6 points on Monday, a difference that Uy called “very clinically significant.”
Equally important, KarXT did not cause the significant side effects experienced by patients taking currently approved treatments for schizophrenia. These drugs often cause weight gain and sedation, which can have major effects on the quality of life of patients with schizophrenia.
Karuna said he plans to file for KarXT approval in the middle of next year. The shares rose 60% on Monday, to $225.66. On Friday, the stock had risen 7.2% so far this year.
Karuna’s data is the latest in a string of positive developments for the biotech sector, where stock prices had fallen since February 2021. A surge in biotech stocks from mid-June continued throughout the summer, supported by positive trial data, including results last week on
‘ (ALNY) Onpattro, and merger activities such as Pfizer’s (PFE) $5.4 billion deal on Monday to
Global Blood Therapeutics
Karuna’s KarXT works differently from treatments currently used for schizophrenia. It does not target the dopamine or serotonin receptors used by current schizophrenia medications, but rather what are called muscarinic receptors. It would be the first of a new class of treatments for schizophrenia.
In a note released early Monday, Citi Research analyst Neena Bitritto-Garg wrote that the results were a “best-case scenario” for the company.
“Based on the totality of data, with efficacy highly comparable to the most effective agents and differentiated tolerability compared to currently branded antipsychotics…these data could position KarXT as the preferred branded option in schizophrenia if it’s approved in ~2024,” Bitritto-Garg wrote.
Karuna is running a number of additional tests of KarXT, including another trial in schizophrenia patients called EMERGENT-3. The first data from this trial is expected early next year, according to the company.
“These results represent our second positive record trial,” company CEO Dr. Steve Paul said in a statement. “We look forward to continuing to gather long-term safety data to support our submission of a New Drug Application to the United States Food and Drug Administration for KarXT as a treatment for schizophrenia, which is expected to occur. produce in mid-2023.”
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