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Citius stock rises as I/ONTAK gets FDA review for rare blood cancer

Dec. 01, 2022 9:19 AM ETCitius Pharmaceuticals, Inc. (CTXR)By: Ravikash, SA News Editor1 Comment

FDA written on wooden cube with keyboard , calculator, chart,glasses.Business concept

Iryna Drozd

  • The U.S. Food and Drug Administration (FDA) accepted for review Citius Pharmaceuticals' (NASDAQ:CTXR) application seeking approval of denileukin diftitox (I/ONTAK or E7777) to treat patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare type of blood cancer.
  • The FDA is expected to make a decision on the biologics license application (BLA) by Sept. 28, 2023.
  • The BLA was backed by data from a phase 3 trial.
  • I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK, the company noted.
  • CTXR +4.27% to $1.22 premarket Dec. 1

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