FDA sets PDUFA date for Citius cancer candidate

The US Food and Drug Administration (FDA) has accepted the resubmission of US critical care specialist Citius Pharmaceuticals’ (Nasdaq: CTXR) Biologics License Application (BLA) for Lymphir (denileukin diftitox).

Lymphir is an interleukin (IL)-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

The FDA has assigned a PDUFA goal date of August 13, 2024. Citius shares edged up 2.2% to $0.74 post-market on the news. The  resubmission follows ongoing discussions with the FDA resulting from a Complete Response Letter (CRL) received by the company in July of last year.