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 reports developments across its critical care and targeted oncology business, including activity at majority-owned subsidiary Citius Oncology. The company’s recurring updates center on LYMPHIR (denileukin diftitox-cxdl), an engineered IL-2 diphtheria toxin fusion protein approved for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy.
Company news also covers LYMPHIR commercialization, U.S. launch progress, international access through Named Patient Programs, and investigator-initiated oncology studies involving gynecologic cancers and diffuse large B-cell lymphoma. Capital updates include registered direct offerings, warrant issuances, non-dilutive funding and other financing actions that support product commercialization and development programs.
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.
Citius Pharmaceuticals, Inc. (CTXR) has announced that abstracts for I/ONTAK (E7777) will be presented at the 64th ASH Annual Meeting on December 11, 2022. The presentations will include an oral review of the efficacy and safety data from the completed Phase 3 study by Dr. Francine Foss, alongside a poster presentation of safety data by Dr. Christiane Querfeld. The company has submitted a Biologics License Application to the FDA, highlighting the potential of I/ONTAK as a treatment for relapsed or refractory cutaneous T-cell lymphoma.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that Chairman and CEO Leonard Mazur will present at the ThinkEquity Conference on October 26, 2022, at 1:00 PM ET, in New York City. The conference will focus on the company's late-stage biopharmaceutical developments, including Mino-Lok® and I/ONTAK, aimed at treating critical health conditions. Investors can register to view the live presentation and are encouraged to request one-on-one meetings through the conference platform.
Citius Pharmaceuticals, a late-stage biopharmaceutical company focused on critical care products, will be represented by Chairman and CEO Leonard Mazur at the Dawson James Securities Small Cap Growth Conference on October 12, 2022, at 3:30 PM ET in Jupiter, Florida. The live presentation will be available via webcast, and a replay will be accessible for 90 days on the Company’s Investors website.
Citius Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for denileukin diftitox (I/ONTAK), targeting cutaneous T-cell lymphoma (CTCL). This engineered IL-2-diphtheria toxin fusion protein offers a more purified formulation of the previously approved ONTAK. The BLA filing is underpinned by a pivotal Phase 3 study whose results align with past data. Citius aims to address the unmet needs in advanced CTCL treatment, highlighting the pressing demand for effective therapies.