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Citius Pharma To Spinoff Late-Stage Oncology Asset Into New Publicly Traded Firm

  • Citius Pharmaceuticals Inc NASDAQ:CTXR plans to form a new company (NewCo) focused on developing and commercializing I/ONTAK. A Phase 3 trial was completed in December 2021, and a biologics license application (BLA) is being planned for submission in the second half of 2022. 
  • The Company's other pipeline assets, including Mino-Lok, would remain at Citius. 
  • Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR. 
  • "As Citius prepares for the commercialization of its two late-stage product candidates, I/ONTAK and Mino-Lok, we believe that the market has not adequately valued the potential of our recent I/ONTAK licensing agreement," stated Leonard Mazur, Chairman, and CEO of Citius.
  • The transactions are expected to be completed in the second half of the calendar year 2022
  • I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor-binding domain with diphtheria toxin fragments. 
  • I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. 
  • ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. 
  • The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL. 
  • In 2011 and 2013, the FDA granted orphan drug designation to I/ONTAK for PTCL and CTCL.
  • Price Action: CTXR shares are down 2.26% at $0.94 on the last check Wednesday.

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