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Friday, December 18, 2020

Fibrogen falls in post-market ahead of FDA decision

 

  • Fibrogen (NASDAQ:FGEN) is down -9.5% in the post-market trading as the company awaits the FDA decision for its small molecule therapy Roxadustat, for the treatment of anemia of chronic kidney disease.
  • In February, the company announced the acceptance of its marketing application by the FDA with PDUFA date set for December 20. The submission is backed by a phase 3 trial involving more than 3,000 patients worldwide.
  • A collaboration with AstraZeneca (NASDAQ:AZN), the drug is already approved in China and Japan for CKD, and the European regulator accepted the company's marketing application in May.
  • https://seekingalpha.com/news/3645986-fibrogen-falls-in-post-market-ahead-of-fda-decision

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