Pfizer submits colitis drug application to FDA, EMA

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Pfizer Inc. PFE, +0.66% said Wednesday that the Food and Drug Administration and the European Medicines Agency accepted the new drug application for its ulcerative colitis treatment candidate. The FDA is expected to make a decision whether to approve etrasimod in the second half of next year. Pfizer recently told investors it expects the drug to generate up to $2 billion in peak sales. The company’s stock is down 13.1% this year, while the broader S&P 500 SPX, +1.49% had declined 19.8%. . e.onventional, biologic, or Janus kinase (JAK) inhibitor therapy. Both randomized, double-blind, placebo-controlled studies achieved all primary and key secondary endpoints, with a safety profile consistent with previous studies. fdsup://factset/Doc%20Viewer%20Single?_expand=pD7Qt5&float_window=true

This article was originally published by Marketwatch.com. Read the original article here.

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