Citius Pharmaceuticals Inc (NASDAQ:CTXR) continues to gain momentum and is trading slightly higher in the opening session on Tuesday.
Market Action
In the opening session, CTXR stock gained by 2% at $2.60. The stock has traded 162 million shares, well below its average volume of 6.38 million shares. The stock opened at $2.65 and moved in a range of $2.5700 – 2.6900.
Major Trigger:
Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial
Key Highlights:
- today announced that the next planned interim analysis in its Phase 3 trial of Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related blood stream infections (CRBSIs/CLABSIs) has been scheduled for the end of June 2021. In accordance with the independent Data Monitoring Committee (DMC) charter, the DMC will hold a meeting to review the trial data for safety, superiority and futility.
- According to the Mino-Lok® Phase 3 study protocol, the DMC is responsible for conducting interim analyses when 40%, 50% and 65% of the total number of anticipated events have been observed. The first two interim analyses were conducted by the DMC in 2019 and 2020, respectively. The next interim analysis meeting of the DMC will be held on June 29, 2021. At that time, the DMC will review unblinded study data and subsequently provide written recommendations to Citius within five business days.
- The Mino-Lok® Phase 3 pivotal superiority trial is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
Key Quote
“We look forward to feedback from the DMC following their review of the trial data,” stated Myron Holubiak, President and Chief Executive Officer of Citius.
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