Citius seeks to get back on track with Lymphir resubmission

US biopharma Citius Pharmaceuticals (Nasdaq: CTXR) has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

The resubmission follows ongoing discussions with the FDA resulting from a Complete Response Letter (CRL) received by the company in July of last year.

Citius has expressed confidence that it has addressed enhanced product testing and additional manufacturing controls noted in the letter, which did not cite safety or efficacy issues or require additional trials to be carried out.