- Citius Pharmaceuticals ( NASDAQ: CTXR ) on Tuesday said it had held a pre-biologics license application (BLA) meeting with the U.S. FDA to discuss its I/ONTAK immunotherapy for the treatment of cutaneous T-cell lymphoma, a rare type of cancer.
- "Based on the FDA's pre-BLA meeting comments, we intend to move forward with our planned BLA submission for I/ONTAK in the second half of 2022," said CTXR CEO Leonard Mazur.
- The purpose of the pre-BLA meeting was to discuss the content and acceptability of the company's anticipated BLA for I/ONTAK.
- Citius ( CTXR ) 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.
- CTXR stock +1.3% to $0.92 in premarket trading.
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Citius holds pre-biologics license application meeting with FDA for immunotherapy I/ONTAK