Compass shares fall 41% after FDA feedback

• Compass Therapeutics (NASDAQ:CMPX) shares fell after the U.S. FDA recommended a new trial before a marketing application for tovecimig.
• The stock declined 40.8% to $1.51 in premarket trading following the regulatory update.
• Compass stated that it disagrees with the need for another trial and plans to continue discussions with the FDA.

Compass Therapeutics (NASDAQ:CMPX) shares declined after the U.S. Food and Drug Administration recommended an additional trial before the company submits a marketing application for tovecimig.

The shares fell 40.8% to $1.51 in premarket trading after the company disclosed the FDA’s recommendation regarding the experimental cancer treatment.

The FDA recommendation relates to demonstrating a survival benefit for tovecimig, which is being evaluated in patients with advanced biliary tract cancer, while Compass said it believes another trial is not warranted based on existing data.

Following the announcement, Compass Therapeutics' share price was down 40.8% at $1.51 in premarket trading.

Tovecimig is an investigational therapy being developed for advanced biliary tract cancer, a rare cancer type affecting the bile ducts or gallbladder.

Compass Therapeutics said it intends to continue discussions with the FDA while considering regulatory options for tovecimig, as the company highlights the unmet medical need among patients with advanced disease.