- 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.
For further details see:
Citius Pharma submits biologics license application to FDA for immunotherapy I/ONTAK