EF Hutton launched coverage of Citius Pharmaceuticals (NASDAQ:CTXR) a “buy” rating and $6 target price. The stock closed at $0.7340 on July 12.
Citius is a pharmaceutical/biotechnology company with two late-stage assets. Mino-Lok (MLT) is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line-associated bloodstream infections (CLABSIs). The second significant asset at the company is LYMPHIR. In September 2021, the company acquired ONTAK / E777, today known as LYMPHIR from Dr. Reddy’s Labs, which acquired the asset from the Japanese pharmaceutical company, Eisai. LYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments.
Analyst Jason Kolbert writes:
“We See “Low-Risk/High-Reward”; associated with both of Citius’ late-stage products, [MLT] and LYMPHIR.
For MLT, results of blinded-assessor clinical outcome analyses in all randomized patients demonstrated that Mino-Lok achieved its primary endpoint with a time to catheter failure occurring in Mino-Lok patients substantially later versus the control arm (p value=0.0006). We expect the company to submit an NDA by 1H25 with a six-month review time.
LYMPHIR (Denileukin Diftitox-cxdl), is a purified reformulation of denileukin diftitox, a previously FDA-approved cancer immunotherapy for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. Improvements to the original formulation have resulted in a therapy that maintains the same amino acid sequence but features greater purity and bioactivity. The phase 3 pivotal trial was completed in December 2021. The BLA for an initial indication in CTCL was submitted in Q3-22 with an August 13, 2024 PDUFA date. LYMPHIR is considered a new biologic by the FDA and should be eligible for 12 years of exclusivity once approved.”
