Citius Pharmaceuticals Inc Stock Price, News & Analysis

Citius Pharmaceuticals, Inc. (CTXR) announced a definitive agreement to acquire Dr. Reddy's Laboratories' exclusive license for E7777, an advanced oncology immunotherapy for treating Cutaneous T-cell Lymphoma (CTCL). The acquisition involves a $40 million upfront payment, additional milestones totaling up to $110 million, and royalty payments on net sales. E7777, a reformulated version of ONTAK, is nearing FDA approval with a Biologics License Application expected by late 2022. Citius aims to enhance its pipeline and target approximately 30% of the CTCL patient population, estimated at 30,000 to 40,000 in the U.S.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) reported its financial results for Q3 2021, showing a net loss of $5.8 million and cash equivalents of $115.7 million. Key highlights include a positive recommendation from the Data Monitoring Committee for the Mino-Lok® trial and advances in stem cell therapy development. The company also raised $127.6 million in financing during H1 2021, with an increase in authorized shares to support growth. However, recruiting for the Mino-Lok® trial may slow due to COVID-19 disruptions.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) provided a business update for the six months ending June 30, 2021. The independent Data Monitoring Committee (DMC) recommended continuing the Phase 3 Mino-Lok® trial with no modifications, citing efficacy signals. The trial is expected to complete by late 2021 or early 2022, with an NDA submission to the FDA planned for 2022. The company raised $127.6 million in financing, with $16.9 million from warrant exercises. Citius aims to leverage these resources to expedite trial completion and advance additional novel products.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that the independent Data Monitoring Committee (DMC) has recommended continuing the Mino-Lok^® Phase 3 Pivotal Superiority Trial without modifications after an unblinded data review confirmed no safety concerns. This trial aims to evaluate the efficacy of Mino-Lok^® in treating catheter-related infections. Approximately 144 subjects will be randomized to assess the treatment's effectiveness. The favorable DMC recommendation reflects the potential to achieve primary endpoints, reassuring stakeholders as Citius engages with the FDA for further guidance.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced the appointment of Dr. John Laffey to its ARDS Scientific Advisory Board, effective immediately. Dr. Laffey is recognized for his expertise in Acute Respiratory Distress Syndrome (ARDS) and gene-based therapies. His involvement aims to enhance Citius's innovative i-MSC program, which focuses on stem cell therapy for ARDS, particularly in relation to COVID-19. This addition complements a board of esteemed experts, indicating a strengthened leadership and potential for advanced clinical development in critical care products.

Citius Pharmaceuticals (CTXR) announced the next interim analysis of its Phase 3 trial for Mino-Lok^®, an antibiotic solution for catheter-related bloodstream infections, is set for June 29, 2021. The independent Data Monitoring Committee (DMC) will review trial data for safety and efficacy. Over 80% of the expected 144 patients are enrolled in the study. Mino-Lok^® aims to be the first FDA-approved treatment for salvaging central venous catheters, potentially reducing serious adverse events and healthcare costs.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced its inclusion in the Russell 2000 Index effective June 28, 2021. This milestone is expected to enhance the company's visibility and attract a broader investment community. The Russell indexes are utilized by institutional investors for asset management and benchmark strategies. Citius focuses on developing first-in-class critical care products, including Mino-Lok®, currently in a Phase 3 trial for treating catheter-related infections. The company also aims to advance stem cell therapy for respiratory conditions.

Citius Pharmaceuticals (Nasdaq: CTXR) announced receiving the Best Poster Award at the ISCT 2021 Annual Meeting for their poster titled "Novel Induced-Mesenchymal Stem Cells (i-MSCs) Attenuate Severity of ARDS in Septic Sheep". Dr. Perenlei Enkhbaatar presented the findings, which highlighted significant improvements in clinical parameters for i-MSC treated animals. Citius is progressing its stem cell therapy for ARDS and has developed a cell bank to support future trials. The recognition underscores the company’s advancements and engagement in cell and gene therapy.

Citius Pharmaceuticals, Inc. (CTXR) announced its participation at the ISCT Annual Meeting on May 26-28, 2021, with a poster presentation on a study evaluating induced pluripotent stem cell-derived mesenchymal stem cells (i-MSCs) for acute lung injury. Interim results indicate promising safety and efficacy signals for i-MSCs in treating Acute Respiratory Distress Syndrome (ARDS), a serious condition with no FDA-approved therapies. The findings could pave the way for future clinical trials in ARDS patients.