Citius Pharmaceuticals Inc. (NASDAQ: CTXR) stock fell by 12.50% in the current trading session. Citius is a late-stage biopharmaceutical business focused on developing and commercializing first-in-class critical care medicines, with a focus on anti-infectives as adjuvant cancer therapy, unique prescription medications, and stem cell therapy.
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What is happening?
Following an unblinded data assessment of safety and effectiveness, Citius Pharmaceuticals reported that the independent Data Monitoring Committee (DMC) for the Mino-Lok Phase 3 Pivotal Superiority Trial has advised that the trial continue as planned. The DMC found no safety issues, and no changes to the protocol-defined sample size or power to meet the primary objective were advised.
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The major purpose of the independent DMC, as specified in the DMC charter, is to protect the interests of research participants, assess the treatment’s safety, and oversee the study’s overall conduct. Each DMC suggestion is limited by rigorous limitations established in the DMC charter in order to ensure the safety of patients participating in the trial and the timely and efficient completion of the research. A recommendation to proceed with the study as planned means that the data evaluated by the DMC is within Citius’ statistical parameters for completing the research with the protocol-defined sample size and power to meet the primary outcome.
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Myron Holubiak, President and CEO of Citius stated,
Following their assessment of the intermediate study results, the Data Monitoring Committee gave critical analysis and recommendations, which CTXR really appreciate. They are delighted with the DMC decision to continue this study without change, which is in line with their expectations. This is the DMC’s third recommendation in favor of the Mino-Lok trial’s continuation. The challenges of meeting their protocol-defined criteria for safety and improved efficacy become more difficult with each DMC review. As a result, this positive result suggests that, based on the pre-defined criteria, CTXR should be able to accomplish their primary goal if they continue the study as planned, which is a promising indication when co-investigators are involved.