FDA to make decision about Karuna’s schizophrenia drug by next September

The FDA is set to de­cide whether to ap­prove Karuna Ther­a­peu­tics’ schiz­o­phre­nia drug by Sept. 26, the Boston biotech said Wednes­day be­fore the mar­kets opened.

The agency’s ac­cep­tance of Karuna’s ap­pli­ca­tion for KarXT, sub­mit­ted in late Sep­tem­ber, marks a mile­stone in the neu­ro­science R&D field. If the agency ap­proves the oral med­ica­tion, then Karuna would mar­ket the first new type of schiz­o­phre­nia drug in decades. It could be a megablock­buster, with Mizuho Se­cu­ri­ties an­a­lysts peg­ging KarXT’s peak sales po­ten­tial at more than $6 bil­lion.

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