NASDAQ-SMALL:CTXR

Citius Pharmaceuticals Announces Closing of $15 Million Registered Direct Offering

Retrieved on: 
Tuesday, April 30, 2024
Sale, Prospectus, 3rd Floor, Security (finance), Public expenditure, Exercise, Telephone

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

Key Points: 
  • H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
  • The aggregate gross proceeds to the Company from the offering were approximately $15 million, before deducting the placement agent fees and other offering expenses payable by the Company.
  • Citius currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.
  • The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Citius Pharmaceuticals Announces Addition of City of Hope to UMN's Phase 1 Trial of LYMPHIR in Combination with CAR-T for the Treatment of B-Cell Lymphoma

Retrieved on: 
Thursday, April 11, 2024
FDA, University, City, Index, Tumor microenvironment, Doctor of Philosophy, National Cancer Institute, Research, Transplant, Lymphoma, Biologics license application, Oncology, COH, Patient, NCI, BCL, UMN, University of Minnesota, Division, Pharmaceutical industry

CRANFORD, N.J., April 11, 2024 /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 University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR™ (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas. The ongoing study, led by Dr. Veronika Bachanova at the University of Minnesota (UMN), will include an additional study site at City of Hope (COH), a world-renowned cancer treatment and research institution, with Dr. Matthew Mei as the principal site investigator at COH. City of Hope is one of only 53 National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S.

Key Points: 
  • "This first-of-its-kind study will evaluate the potential value that transient depletion of T-regs within the tumor microenvironment by LYMPHIR has upon CAR-T-based anti-tumor activity," added Dr. Czuczman.
  • "This trial is designed to augment lymphodepletion prior to CAR-T cells by administration of targeted immunotoxin against IL-2 receptor-positive regulatory T-cells.
  • Citius is collaborating with the University of Minnesota (UMN) in this investigator-initiated study.
  • Enrollment is underway for patients diagnosed with relapsed or refractory BCL, for which treatment with CAR-Ts is planned, and who are considered at high risk for progression after CAR-T therapy.

Citius Pharmaceuticals to Present at the LD Micro Invitational XIV Investor Conference

Retrieved on: 
Thursday, April 4, 2024

CRANFORD, N.J., April 4, 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 Chairman and CEO Leonard Mazur will present at the 14th Annual LD Micro Invitational investor conference being held April 8-9, 2024, in New York City.

Key Points: 
  • CRANFORD, N.J., April 4, 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 Chairman and CEO Leonard Mazur will present at the 14th Annual LD Micro Invitational investor conference being held April 8-9, 2024, in New York City.
  • 3:30pm ET on April 9, 2024

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Retrieved on: 
Friday, March 22, 2024
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Key Points: 
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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

Retrieved on: 
Monday, March 18, 2024
T-cell lymphoma, PDUFA, Symantec Endpoint Protection, Letter, Disease, Patient, CRL, CTCL, Drug development, Safety, FDA, BLA, Food, Pharmaceutical industry

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. The FDA has assigned a PDUFA goal date of August 13, 2024.

Key Points: 
  • "The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.
  • "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative.
  • We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.
  • The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.

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

Retrieved on: 
Monday, February 26, 2024
Security (finance), Form S-3

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.

Key Points: 
  • 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 to Participate in Upcoming BIO CEO and Sidoti Investor Conferences

Retrieved on: 
Friday, February 23, 2024
Sidoti, BIO, Conference, Cryptocurrency

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.

Key Points: 
  • 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 Chairman and CEO Leonard Mazur will present at the BIO CEO and Investor Conference on February 26-27, 2024, and the Sidoti Small-Cap Virtual Conference on March 13-14, 2024.
  • BIO CEO and Investor Conference Details:
    9:45 am ET on Tuesday, February 27, 2024
    Sidoti Small-Cap Virtual Conference Details:
    1:45 pm ET on Wednesday, March 13, 2024

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

Retrieved on: 
Wednesday, February 14, 2024
TenX, Shareholder, Catheter, Accounting, Research, FDA, Food, Hemorrhoid, BLA, Calendar, PDUFA, FIRST, G&A, Pharmaceutical industry

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.

Key Points: 
  • "We had a strong first quarter of fiscal 2024 during which we achieved multiple mission critical goals.
  • FIRST QUARTER 2024 Financial Results:
    As of December 31, 2023, the Company had $20.3 million in cash and cash equivalents.
  • R&D expenses were $2.6 million for the first quarter ended December 31, 2023, compared to $3.4 million for the first quarter ended December 31, 2022.
  • G&A expenses were $3.7 million for the first quarter ended December 31, 2023, compared to $2.6 million for the first quarter ended December 31, 2022.

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

Retrieved on: 
Wednesday, February 14, 2024
Symantec Endpoint Protection, FDA, Food, Safety, BLA, CRL, PDUFA, CTCL, Letter, Patient

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.

Key Points: 
  • The resubmission follows ongoing engagement with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.
  • Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter.
  • There were no safety or efficacy issues cited and no additional trials required.
  • Based on Center for Drug Evaluation and Research timelines, 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.

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

Retrieved on: 
Tuesday, January 23, 2024
Focused Ultrasound Foundation, Research, Corporation, Business administration, University, Regenerative medicine, Growth, Therapy, Disease, Cell, Senior, Health, Gene, Acquisition, ARM, Partnership, Management

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. Smith to its Board of Directors. The nomination of Mr. Smith is subject to shareholder approval at the Citius Annual Shareholders' Meeting to be held on March 12, 2024. Upon approval, the Citius Board of Directors will consist of seven members.

Key Points: 
  • 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. Smith to its Board of Directors.
  • The nomination of Mr. Smith is subject to shareholder approval at the Citius Annual Shareholders' Meeting to be held on March 12, 2024.
  • Upon approval, the Citius Board of Directors will consist of seven members.
  • We are privileged to have an executive of Bob's caliber join our Board of Directors.