- 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- ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market.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.
