BUZZ - The US Food and Drug Administration recommends new clinical trials before submitting a marketing application; Compass shares tumble in response.
路透社2026/09/22 12:56September 22 - ** Compass Therapeutics (CMPX.O) shares fell 40.8% in premarket trading to $1.51
** The company said the U.S. Food and Drug Administration (FDA) recommended conducting a new trial to demonstrate the survival benefit of its experimental drug tovecimig before submitting a marketing application
** Tovecimig is currently undergoing clinical trials in patients with advanced biliary tract cancer, a rare and highly aggressive malignancy originating in the bile ducts or gallbladder
** Based on mid- to late-stage clinical trial results and the urgent unmet medical needs of patients, Compass said it believes a new clinical trial is unnecessary prior to submitting a marketing application
** The company said it plans to further communicate with the U.S. Food and Drug Administration (FDA)
** As of the close of the previous trading day, the company's shares have fallen 66% so far this year
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