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BUZZ - The US Food and Drug Administration recommends new clinical trials before submitting a marketing application; Compass shares tumble in response.

BUZZ - The US Food and Drug Administration recommends new clinical trials before submitting a marketing application; Compass shares tumble in response.

路透社路透社2026/09/22 12:56
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- ** 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


(To facilitate non-native English speakers, Reuters offers its reports automatically translated into several other languages. As automated translations may contain errors or lack the desired context, Reuters does not guarantee the accuracy of the automated translation. The automated translation is provided solely for reader convenience. Reuters is not liable for any damage or loss caused by the use of this automated translation service.)

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