Citius Pharma submits biologics license application to FDA for immunotherapy I/ONTAK

Sep. 28, 2022 8:56 AM ETCitius Pharmaceuticals, Inc. (CTXR)By: Anuron Mitra, SA News Editor1 Comment

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  • Citius Pharmaceuticals (NASDAQ:CTXR) on Wednesday said it had submitted a biologics license application (BLA) to the U.S. FDA for its I/ONTAK immunotherapy for the treatment of cutaneous T-cell lymphoma, a rare type of cancer.
  • According to CTXR, I/ONTAK (denileukin diftitox) is a purified and more bioactive formulation of previously FDA-approved therapy ONTAK.
  • The BLA submission was supported by results from a phase 3 study.
  • The submission comes after CTXR held a pre-BLA meeting with the FDA in July.
  • The company in May had said that it planned to form a new company focused on developing and commercializing I/ONTAK, with an IPO planned for H2 2022.
  • "The BLA filing for denileukin diftitox marks the first of our pipeline candidates to be submitted for FDA approval," CTXR CEO Leonard Mazur said in Wednesday's statement.
  • Citius Pharmaceuticals (CTXR) stock -0.9% to $1.17 in premarket trading.

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