CMPX Stock Crashes To Over 2-Year Lows — Why FDA Wants Another Cancer Therapy Trial Before Key Marketing Filing

The FDA wants Compass to conduct a trial showing Tovecimig can improve overall survival in patients with previously treated, advanced biliary tract cancer.

• Compass’ study showed improved tumor response and progression-free survival but did not show a statistically significant overall survival.
• Compass believes another trial is unnecessary and plans further discussions with the FDA.
• The company ended June with about $180 million in cash and marketable securities, which it expects will fund operations into 2028.

Shares of Compass Therapeutics (CMPX) crashed more than 25% on Tuesday after the U.S. Food and Drug Administration (FDA) recommended an additional trial for its lead cancer drug, potentially delaying the company’s path toward commercialization.

At the time of writing, CMPX shares traded at their lowest levels since August 2024 and were on track to record their sharpest single-day losses in nearly five months.

FDA Wants Additional Trial Focusing On Overall Survival

Compass said that the FDA wants it to conduct a trial demonstrating that Tovecimig can improve overall survival in patients with previously treated, advanced biliary tract cancer (BTC).

The issue stems from Compass’ Phase 2/3 Companion-002 study, which tested Tovecimig plus chemotherapy drug Paclitaxel against Paclitaxel alone. The study produced positive results on two measures.

The objective response rate, which measures the proportion of patients with meaningful tumor shrinkage, was 18% with Tovecimig versus 5.3% in the control group. Median progression-free survival, which indicates how long patients lived without their cancer worsening, was also longer at 4.7 months versus 2.6 months.

However, the study did not demonstrate a statistically significant improvement in overall survival, which measures how long patients lived.

Conducting an additional trial would increase Compass's costs. The company ended June with about $180 million in cash and marketable securities, which it expects will fund operations into 2028.

What’s Next For CMPS?

Compass said it disagrees that another trial is necessary and plans further discussions with the agency while continuing to prepare its Biologics License Application (BLA).

Compass said the survival results were difficult to interpret because many patients in the control group later began receiving Tovecimig, making it harder to show a clear survival benefit between the two groups.

“While this is not the response we expected, we respect the FDA’s feedback,” CEO Thomas Schuetz said, adding that Compass remains confident in the study’s results.

Retail Expects CMPX To Bounce Back

Despite the slump, retail sentiment surrounding CMPX on Stocktwits turned ‘bullish’ from ‘neutral’ over the past 24 hours, amid ‘high’ message volumes.

One user called the decline a “panic-driven sell-the-news drop” and expects the stock to bounce back to $1.80. It’s currently at $1.34.

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The stock has crashed more than 74% so far in 2026.

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