Citius Pharmaceuticals

Citius Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in the development and commercialization of critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, prescription products, and stem cell therapy. Its products include I/ONTAK, Mino-Lok, Halo-Lido, Mino-Wrap, and Novecite. The company was founded by Ralph Montrone on January 23, 2007 and is headquartered in Cranford, NJ.

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The article provides an updated analysis of Citius Pharmaceuticals following a previous piece in February 2023. Citius' lead therapy has a midsummer 2023 PDUFA; it has generated excitement among investors, although it is unlikely to generate alpha. Its second lead therapy is likely to disappoint.

Citius Pharmaceuticals: Steer Clear From This One

$29.1 million in cash and cash equivalents as of March 31, 2023; $15 million registered direct offering in May 2023 extends runway through May 2024 Halo-Lido Phase 2b trial completed with topline results anticipated by end of calendar Q2 2023 CRANFORD, N.J. , May 12, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal second quarter ended March 31, 2023.

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2023 Financial Results and Provides Business Update

CRANFORD, N.J. , April 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has advanced its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections.

Citius Pharmaceuticals Advances Mino-Lok® Phase 3 Trial Achieving 85 of 92 Events to Date

Topline Results anticipated by the end of Q2 2023 CRANFORD, N.J. , April 3, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that the last patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoids.

Citius Pharmaceuticals Completes Enrollment in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids

CRANFORD, N.J. , March 30, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) , a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Maxim Group LLC will serve as financial advisor to its wholly-owned subsidiary, Citius Acquisition Corp. Inc., in connection with the intended formation of a separate publicly-traded entity to commercialize and grow Citius' oncology asset, I/ONTAK.

Citius Pharmaceuticals Advances Efforts to Spin Off Oncology Asset, I/ONTAK, into a Standalone Public Company

CRANFORD, N.J. , March 13, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) confirms that it does not hold any cash or maintain any accounts at Silicon Valley Bank (SVB), and has no current or prior business relationship with SVB.

Citius Pharmaceuticals Confirms No Exposure to Silicon Valley Bank

CRANFORD, N.J. , March 8, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced its participation in the 35th Annual Roth Conference being held March 12-14, 2023 in Dana Point, California.

Citius Pharmaceuticals to Participate in the 35th Annual Roth Conference

$36.9 million in cash and cash equivalents as of December 31, 2022; runway through February 2024 Uptick in patient recruitment for Mino-Lok® Phase 3 trial Halo-Lido Phase 2b trial nearing completion CRANFORD, N.J. , Feb. 10, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter ended December 31, 2022.

Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023 Financial Results and Provides Business Update

CRANFORD, N.J. , Jan. 11, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023.

Citius Pharmaceuticals to Present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023

The heavy selling pressure might have exhausted for Citius Pharmaceuticals, Inc. (CTXR) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

After Plunging -30.6% in 4 Weeks, Here's Why the Trend Might Reverse for Citius Pharmaceuticals, Inc. (CTXR)

$41.7 million in cash and cash equivalents as of September 30, 2022; extends runway through December 2023 Mino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review I/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023 Halo-Lido Phase 2b trial progressed; data readout expected 2H 2023 Multiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions CRANFORD, N.J., Dec. 22, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal full year ended September 30, 2022.

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Financial Results and Provides Business Update

Prescription Drug User Fee Act (PDUFA) target action date is September 28, 2023 CRANFORD, N.J. , Dec. 1, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).

Citius Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

Net operating losses converted into non-dilutive capital for ongoing R&D programs CRANFORD, N.J., Nov. 21, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer (NOL) Program, more commonly known as the Net Operating Loss (NOL) Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority (NJEDA).

Citius Pharmaceuticals, Inc. Secures $3.6 million through New Jersey Economic Development Program

Oral and Poster Presentations to Highlight Clinical Data for I/ONTAK (E7777) Study in Relapsed or Refractory Cutaneous T-cell Lymphoma on December 11, 2022 CRANFORD, N.J. , Nov. 9, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that abstracts for I/ONTAK (E7777) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) have been accepted for presentations at the prestigious 64th American Society of Hematology (ASH) Annual Meeting, to be held in New Orleans, December 10-13, 2022.

Citius Pharmaceuticals Announces Efficacy and Safety Data for its I/ONTAK (E7777) Phase 3 Study for Treatment of Cutaneous T-Cell Lymphoma to be Presented at the 64th American Society of Hematology (ASH) Annual Meeting

Citius Pharmaceuticals, Inc. has a handful of catalysts set to occur in the next few months. Of these, some are critical to extending its cash runway far enough to reach commercialization of its major products, and are therefore a "must complete" by the company.

Citius Pharmaceuticals: Large Price Action Imminent From Catalysts Within 60 Days

CRANFORD, N.J. , Oct. 18, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will be presenting at the ThinkEquity Conference on October 26, 2022.

Citius Pharmaceuticals to Present at the ThinkEquity Conference on October 26, 2022

CRANFORD, N.J. , Oct. 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will be presenting at the Dawson James Securities Small Cap Growth Conference on October 12, 2022.

Citius Pharmaceuticals to Present at Dawson James Securities Small Cap Growth Conference on October 12, 2022

CRANFORD, N.J. , Sept. 28, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denileukin diftitox (I/ONTAK), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).

Citius Pharmaceuticals, Inc. Submits Biologics License Application to the U.S. Food and Drug Administration for Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

I/ONTAK plus PD-1 checkpoint inhibitor pembrolizumab to be evaluated in solid tumor patients University of Pittsburgh dose-ranging study expected to begin in the fourth quarter of 2022 Collaboration marks second investigator-initiated study of I/ONTAK as combination immunotherapy CRANFORD, N.J. , Sept. 22, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced a collaboration with Dr. Haider Mahdi at the University of Pittsburgh in an investigator-initiated trial to evaluate I/ONTAK ("denileukin diftitox" or "E7777") in combination with pembrolizumab in the treatment of recurrent or metastatic solid tumors.

Citius Pharmaceuticals Announces a Clinical Collaboration with the University of Pittsburgh to Evaluate T-reg Cell Depletion with I/ONTAK (E7777) in Combination with Pembrolizumab in Recurrent or Metastatic Solid Cancer Tumors in a Phase 1 Investigator-In

Leading Center for Autism Education and Research has named Citius and Bartushak the 2022 Honorees for their annual Halloween Gala CRANFORD, N.J. , Sept. 15, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Citius, along with the Company's Chief Financial Officer and Chief Business Officer, Jaime Bartushak, were named as 2022 Honorees by the Somerset Hills Learning Institute ("The Institute").

Citius Pharmaceuticals, Inc. and its CFO & CBO Jaime Bartushak Honored by Somerset Hills Learning Institute

UPDATED: Chairman & CEO of Citius, Leonard Mazur, to present September 12, 2022 at 8:30am ET CRANFORD, N.J. , Sept. 8, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), today announced that Citius will participate in the H.C.

Citius Pharmaceuticals, Inc. to Present at the H.C. Wainwright 24th Annual Global Investment Conference

$48.0 million in cash and cash equivalents as of June 30, 2022 to support ongoing programs through August 2023 International sites for Mino-Lok® Phase 3 trial engaged as recruitment accelerates I/ONTAK Biologics License Application (BLA) on track for 2H 2022 submission CRANFORD, N.J. , Aug. 11, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today reported business and financial results for the third fiscal quarter of 2022 ended June 30, 2022.

Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2022 Financial Results and Provides Business Update

Biologics License Application (BLA) submission planned for the second half of 2022 CRANFORD, N.J. , July 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company held a Type B pre-BLA meeting with the U.S. Food and Drug Administration (FDA) to discuss I/ONTAK (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).

Citius Pharmaceuticals, Inc. Holds Pre-BLA Meeting with the FDA for I/ONTAK (denileukin diftitox) for the Treatment of Cutaneous T-Cell Lymphoma

Citius Pharmaceuticals is yet to release test results a year after it was granted positive recommendation by the Independent Data Monitoring Committee (IDMC) to proceed with the planned trial. With the help of Biorasi, Citius could reach full patient enrolment by the end of 2022, as earlier indicated.

Citius Pharmaceuticals: Hoping For A Turnaround Strategy

IPO with distribution of shares to Citius shareholders planned for 2H 2022 Citius would retain Mino-Lok and other pipeline assets and continue to trade on Nasdaq (ticker: CTXR) CRANFORD, N.J. , May 25, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it intends to split the Company's assets into two separate publicly-traded entities.

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