Compass falls after FDA recommends fresh trial before marketing application submission
CMPX•FDA recommends new trial before marketing application
Shares of Compass Therapeutics CMPX.O fell 40.8% to $1.51 premarket.
The company said the U.S. FDA recommended a new trial to demonstrate survival benefit before submitting a marketing application for its experimental drug, tovecimig.
Tovecimig is being tested in patients with advanced biliary tract cancer, a rare and aggressive type of malignancy that starts in the bile ducts or gallbladder.
Compass said it does not believe that a new trial is warranted prior to submitting a marketing application, based on its mid- to late-stage trial and the urgent unmet medical need for patients.
The company said it intends to further engage with the FDA.
Up to the last close, the stock was down 66% year to date.
