- 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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