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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FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024 CRANFORD, N.J., March 18, 2024 /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 the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Net operating losses converted into non-dilutive capital CRANFORD, N.J. , March 7, 2024 /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 the Company has received $2.4 million in non-dilutive capital through New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss (NOL) Program, funded through the New Jersey Economic Development Authority (NJEDA).

Citius Pharmaceuticals, Inc. Secures $2.4 million through New Jersey Economic Development Program

CRANFORD, N.J. , Feb. 26, 2024 /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 the Company filed a Form S-3 shelf registration on February 23, 2024 with the Securities and Exchange Commission to replace its currently effective shelf registration statement that expires in April 2024 pursuant to SEC rules.

Citius Pharmaceuticals Announces Filing of Form S-3 Shelf Registration Statement to Replace Expiring Prior Shelf Registration

CRANFORD, N.J. , Feb. 23, 2024 /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 two upcoming investor conferences.

Citius Pharmaceuticals to Participate in Upcoming BIO CEO and Sidoti Investor Conferences

Resubmitted LYMPHIR™ Biologics License Application; awaiting PDUFA date Completed enrollment in the Mino-Lok® Pivotal Phase 3 trial CRANFORD, N.J. , Feb. 14, 2024 /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 2024 ended December 31, 2023.

Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2024 Financial Results and Provides Business Update

FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission CRANFORD, N.J. , Feb. 13, 2024 /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 the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Independent Director nominee expected to be elected at Annual Shareholders' Meeting in March 2024 CRANFORD, N.J. , Jan. 23, 2024 /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 the nomination of seasoned pharmaceutical executive Robert J.

Citius Pharmaceuticals Announces Nomination of Pharmaceutical Executive Robert J. Smith to its Board of Directors

Topline results expected 2Q 2024 Study enrolled a total of 241 patients; 109 catheter failures observed First-and-only antibiotic lock solution in development to salvage catheters in patients with CRBSI CRANFORD, N.J., Jan. 2, 2024 /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 completed enrollment in its pivotal Phase 3 clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections.

Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok® Therapeutic to Salvage Catheters

TenX Keane Acquisition

Mino-Lok® Pivotal Phase 3 trial enrollment completed; topline data expected 2Q 2024 LYMPHIR™ BLA resubmission on track for early 2024 CRANFORD, N.J. , Jan. 2, 2024 /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, 2023.

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2023 Financial Results and Provides Business Update

CRANFORD, N.J. , Nov. 9, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will present at the Sidoti Micro-Cap Virtual Conference on November 15, 2023.

Citius Pharmaceuticals to Participate in the Sidoti Micro-Cap Virtual Conference on November 15, 2023

Preclinical study demonstrates that adding LYMPHIR to anti-PD-1 treatment augments anti-tumor activity and improves overall survival compared to monotherapy alone by transiently depleting Tregs in the tumor microenvironment CRANFORD, N.J. , Oct. 31, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that preclinical research on LYMPHIR ("denileukin diftitox" or "E7777") was published today in Frontiers in Immunology 1, a leading peer-reviewed journal in the immunology field.

Citius Pharmaceuticals Announces Publication in Frontiers of Immunology of Positive Results from Solid Tumor Study of LYMPHIR™ in Combination with Checkpoint Inhibitor

Citius Pharmaceuticals, Inc. to receive $675 million in equity of Citius Oncology, Inc. and retain approximately 90% majority control in publicly listed Citius Oncology, Inc. post transaction Transaction anticipated to close in the first half of 2024 CRANFORD, N.J. and NEW YORK , Oct. 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition ("TenX") (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma's wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

CRANFORD, N.J. , Sept. 18, 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, has rescheduled its participation in Sidoti's Small-Cap Virtual Conference to November 2023 due to funeral services for the late Howard Safir, a long-time member of the Citius Board.

Citius Pharmaceuticals Reschedules Participation in Sidoti Small-Cap Virtual Investor Conference for November 2023

CRANFORD, N.J. , Sept. 13, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) mourns the loss of longtime board member, Howard Safir, who passed away on Monday.

Citius Pharmaceuticals Mourns the Loss of Board Member, Howard Safir

Resubmission to FDA planned for early 2024 CRANFORD, N.J. , Sept. 8, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) is pleased to announce the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Citius Pharmaceuticals, Inc. Receives Regulatory Guidance from the U.S. Food and Drug Administration (FDA) regarding the Planned Resubmission of the BLA for LYMPHIR™

CRANFORD, N.J. , Sept. 6, 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 two investor conferences in September 2023.

Citius Pharmaceuticals to Participate in H.C. Wainwright and Sidoti Investor Conferences in September 2023

$33.3 million in cash and cash equivalents as of June 30, 2023; runway through August 2024 CRANFORD, N.J. , Aug. 14, 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 third quarter ended June 30, 2023.

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

CRANFORD, N.J. , Aug. 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 announced that it has reached an important milestone in its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections.

Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok® Phase 3 Trial

No clinical efficacy or safety issues raised Citius committed to working toward approval CRANFORD, N.J. , July 29, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company's Biologics License Application (BLA) seeking approval for denileukin diftitox ("LYMPHIRTM"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Citius Pharmaceuticals, Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma

CRANFORD, N.J. , June 26, 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 it is set to be added to the broad-market Russell 3000® Index and the small-cap Russell 2000® Index at the conclusion of the annual reconstitution of Russell US Indexes, effective at the opening of the U.S. equity markets on June 26, 2023.

Citius Pharmaceuticals to be Added to Russell 3000® and Russell 2000® Indexes

CITI-002 provides a meaningful reduction in symptom severity when compared to individual components alone Dose for Phase 3 trial selected; Citius to schedule end of Phase 2 meeting with the FDA Trial validates Patient Reported Outcome (PRO) instrument developed to support a pivotal Phase 3 study  CRANFORD, N.J. , June 20, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR) today announced results from the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoid symptoms.

Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids

CRANFORD, N.J. , June 13, 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 participate in a fireside chat with Senior Biotech Research Analyst, Michael Okunewitch, at Maxim Group's Virtual Healthcare Conference on June 21, 2023.

Citius Pharmaceuticals to Participate in Maxim Group's Virtual Healthcare Conference on June 21, 2023

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.

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