Citius Pharmaceuticals Inc Stock Price, News & Analysis

Citius Pharmaceuticals (NASDAQ: CTXR) has made significant progress in its Mino-Lok® Phase 3 clinical trial, now achieving 85 of the 92 events required for completion. Currently, 190 patients have been enrolled, with 16 patients actively receiving treatment or pending data review. The trial involves multiple centers across 35 sites in the U.S. and India. Mino-Lok® is an antibiotic lock solution aimed at salvaging catheters in patients suffering from catheter-related bloodstream infections (CRBSI/CLABSI). If approved, it would be the first FDA-approved treatment for this condition. The positive trajectory of this trial could lead to significant advancements in critical care and strengthen Citius’s market position.

Citius Pharmaceuticals (CTXR) announced the completion of patient enrollment in its Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation aimed at treating hemorrhoids. The study enrolled approximately 300 adults and its results are expected by the end of Q2 2023. This trial marks an important milestone as CITI-002 could become the first prescription product for hemorrhoids if approved by the FDA. The company aims to leverage these results to advance to a Phase 3 study, reflecting its belief in a significant market opportunity for a prescription hemorrhoid treatment.

Citius Pharmaceuticals (Nasdaq: CTXR) announced it will engage Maxim Group LLC as a financial advisor for its subsidiary, Citius Acquisition Corp. Inc. This initiative aims to spin off its oncology asset, I/ONTAK, into a publicly-traded company. The FDA is reviewing the biologics license application (BLA) for I/ONTAK, targeting a decision by July 28, 2023. Citius intends to maximize I/ONTAK’s value while maintaining its trading status on Nasdaq. Any transactions will be subject to board and regulatory approvals. Investors are cautioned that the completion of these transactions is uncertain and is dependent on various conditions.

Citius Pharmaceuticals (Nasdaq: CTXR) announced on March 13, 2023 that it has no cash or accounts with Silicon Valley Bank and has never had a business relationship with the bank. This statement may provide reassurance to investors regarding the company's financial stability amid recent concerns surrounding SVB. Citius specializes in the development of critical care products, particularly in oncology and anti-infectives, and is advancing multiple late-stage product candidates, including Mino-Lok® and I/ONTAK (E7777), which are under FDA review.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced participation in the 35th Annual Roth Conference scheduled for March 12-14, 2023, in Dana Point, California. Citius Chairman and CEO Leonard Mazur will conduct one-on-one meetings with institutional investors on March 13th and March 14th. The conference will take place at The Ritz Carlton, Laguna Niguel. Interested investors can register through the conference website. Citius specializes in critical care products, with ongoing trials for Mino-Lok® and I/ONTAK, both under FDA review.

Citius Pharmaceuticals reported its fiscal Q1 2023 results, highlighting a net loss of $3.6 million or $0.02 per share, a significant reduction from the $9.2 million loss in Q1 2022. The company holds $36.9 million in cash, sufficient to fund operations through February 2024. Key developments include progress in the Mino-Lok® Phase 3 trial and nearing completion of the Halo-Lido Phase 2b trial. The FDA is reviewing the I/ONTAK (E7777) biologics license application, with a decision expected by July 28, 2023. Overall, Citius is focused on advancing its clinical programs while managing operational costs effectively.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a late-stage biopharmaceutical company, announced that Chairman and CEO Leonard Mazur will present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023, at 10:45 AM ET. The presentation will be accessible to registered viewers, and investors can request one-on-one meetings through their Sidoti representative or Citius Investor Relations. Citius focuses on developing first-in-class critical care products, with ongoing projects like Mino-Lok® and I/ONTAK, aimed at addressing critical health challenges.

Citius Pharmaceuticals (CTXR) reported strong progress in its fiscal year 2022 results, ending September 30, 2022, with $41.7 million in cash, extending its operational runway through December 2023. The company successfully recruited 169 patients for the Mino-Lok® Phase 3 trial and achieved 72 required catheter failure events, with 17 patients pending further data review. Notably, the FDA accepted the I/ONTAK (E7777) BLA filing, setting a PDUFA date of July 28, 2023. Citius anticipates significant catalysts in 2023, including potential drug approvals and trial completions, but reported a net loss of $33.6 million for the year.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that the FDA has accepted its Biologics License Application (BLA) for I/ONTAK (denileukin diftitox) aimed at treating cutaneous T-cell lymphoma (CTCL). The target action date under the Prescription Drug User Fee Act (PDUFA) is September 28, 2023. I/ONTAK is a reformulated version of ONTAK, previously approved but withdrawn in 2014. With this acceptance, Citius highlights the potential approval of a significant treatment option for a rare disease with limited alternatives.