Welcome to our dedicated page for Citius Pharmaceuticals news (Ticker: CTXR), a resource for investors and traders seeking the latest updates and insights on Citius Pharmaceuticals stock.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company focused on first-in-class critical care products and holds a majority interest in Citius Oncology, Inc. News about CTXR often centers on regulatory milestones, clinical progress, and financing activities that support the development and commercialization of its therapies.
Recent company communications emphasize the FDA approval of LYMPHIR (denileukin diftitox-cxdl) for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy, and the subsequent U.S. commercial launch executed by Citius Oncology. CTXR news also highlights the late-stage status of Mino-Lok, a catheter lock solution for catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, along with completed pivotal and Phase 2b trials.
Investors following CTXR can expect updates on capital raises such as registered direct offerings and warrant issuances, which the company states are intended to fund the commercial launch of LYMPHIR, regulatory and milestone payments, and broader development initiatives. Filings and press releases also describe ongoing engagement with the FDA regarding next steps for Mino-Lok and Halo-Lido.
This news feed aggregates press releases, regulatory disclosures, and other public announcements related to Citius Pharmaceuticals and its majority-owned oncology subsidiary. For those tracking CTXR, it provides a centralized view of developments across oncology, critical care, clinical trials, and corporate finance. Regular review of this page can help readers monitor how Citius Pharmaceuticals advances its portfolio and supports the commercialization of LYMPHIR through Citius Oncology.
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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
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.