Citius Pharmaceuticals Inc Stock Price, News & Analysis

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 I/ONTAK is a reformulated version of ONTAK, previously approved but withdrawn in 2014.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.

Citius Pharmaceuticals, Inc. (CTXR) announced a collaboration with the University of Pittsburgh for a Phase 1 clinical trial evaluating I/ONTAK in combination with pembrolizumab for treating recurrent or metastatic solid tumors. This trial aims to enhance T-cell responses, potentially improving patient outcomes. The study, set to begin in Q4 2022, aims to enroll 18-30 patients in a dose escalation followed by approximately 40 patients for dose expansion. The trial seeks to assess safety, tolerability, and immune response alterations, advancing innovative cancer treatments.

Citius Pharmaceuticals, Inc. (CTXR) has been honored by the Somerset Hills Learning Institute, with its CFO Jaime Bartushak receiving recognition for their contributions. The Institute focuses on autism education and has saved New Jersey taxpayers over $60 million by returning children to neighborhood schools. The 23rd Annual Halloween Ball, the Institute's largest fundraising event, is scheduled for October 28, 2022. Citius is engaged in developing critical care products, including Mino-Lok® and I/ONTAK, with ongoing clinical trials expected to influence its market position.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 11:00 am EDT. Chairman and CEO Leonard Mazur will conduct an in-person presentation at the Lotte New York Palace Hotel, with registered participants able to access the live webcast. Citius focuses on developing critical care biopharmaceuticals, including late-stage candidates Mino-Lok® and I/ONTAK (E7777). The conference runs from September 12-14, 2022, in New York City.