Compass Therapeutics says FDA urges survival-benefit trial before tovecimig BLA in biliary tract cancer
Bitget2026/09/22 12:33- Compass Therapeutics disclosed FDA feedback urging a new study to show a survival benefit before a BLA for tovecimig in biliary tract cancer.
- Results from the already reported COMPANION-002 trial showed improved tumor responses and delayed disease worsening versus chemotherapy alone.
- Survival results did not reach statistical significance, with the analysis complicated by crossover from the control arm.
- The company plans further FDA engagement while continuing preparations for a BLA submission without running an additional pre-filing trial.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
You may also like
Citi optimistic about international oil companies: low-cost resource reserves being rebuilt may drive energy sector to reverse a decade-long valuation discount
With oil prices in the mid-$70s range, Citi believes that global international oil companies (IOCs) can deliver a free cash flow yield of 7% to 8%, and achieve a real growth rate of 4% to 5% over a period of time.
Honda Motor (HMC.US) Reports 65.7% Increase in Net Profit in the First Half, Plans to Expand Production Capacity in North America and Brazil
Honda Motor (HMC.US) released its financial results for the first half of fiscal year 2027 on November 10.
Crypto winter not over? Mining rig hosting provider Bitari cancels orders at the last minute, IPO plans put on hold
Bitcoin mining service provider Bitari has withdrawn its Nasdaq IPO plan. The company originally intended to issue 4.3 million shares at $7 per share to raise $30 million. Its annual revenue is approximately $11 million.
Crypto prices
More
