NASDAQ-SMALL:CTXR

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

Retrieved on: 
Thursday, March 30, 2023
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"Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline.

Key Points: 
  • "Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline.
  • Any transactions would be subject to the satisfaction of customary conditions, including final approval from the Citius Board of Directors, regulatory approvals, and SEC filings.
  • Upon closing of the transactions, Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR.
  • There can be no assurance regarding the ultimate timing of proposed transactions or that the transactions will be completed at all.

Citius Pharmaceuticals Confirms No Exposure to Silicon Valley Bank

Retrieved on: 
Monday, March 13, 2023
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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.

Key Points: 

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 to Participate in the 35th Annual Roth Conference

Retrieved on: 
Wednesday, March 8, 2023
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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.

Key Points: 
  • 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 Chairman and CEO Leonard Mazur will host one-on-one meetings with institutional investors and analysts on Monday, March 13th and Tuesday, March 14th.
  • Citius Chairman and CEO Leonard Mazur to host 1x1 meetings with institutional investors and analysts.
  • The Ritz Carlton, Laguna Niguel in Dana Point, California.

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

Retrieved on: 
Wednesday, January 11, 2023
Conference, Sidoti, Citius, Altius, Fortius, Pharmaceutical industry, Fine chemical

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.

Key Points: 
  • 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, 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

Retrieved on: 
Thursday, December 1, 2022
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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). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727). 

Key Points: 
  • "The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program.
  • I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.
  • The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
  • Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma.

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

Retrieved on: 
Monday, November 21, 2022
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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 expects to receive the funds by late 2022 or early 2023.

Key Points: 
  • "This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program.
  • We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation.
  • The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million.
  • The New Jersey Economic Development Authority (NJEDA) serves as the State's principal agency for driving economic growth.

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

Retrieved on: 
Wednesday, November 9, 2022
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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.

Key Points: 
  • I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments.
  • ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market.
  • The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
  • Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma.

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

Retrieved on: 
Thursday, October 6, 2022
PTCL, Grand Hotel, Peripheral T-cell lymphoma, Citius, Altius, Fortius, Hemorrhoid, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, Multimedia, Pivotal, Food, T-cell lymphoma, IL-2R, Company, CTCL, BLA, Immunotherapy, Fast Track, FDA, Pharmaceutical industry

Wyndham Grand Hotel in Jupiter, Florida

Key Points: 
  • Wyndham Grand Hotel in Jupiter, Florida
    To request a meeting, please contact your Dawson James representative.
  • I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
  • In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.
  • The Company anticipates completing enrollment in the Halo-Lido trial by the end of 2022.

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

Retrieved on: 
Wednesday, September 28, 2022
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"The treatment of advanced cutaneous T-cell lymphoma remains a complex and challenging unmet medical need.

Key Points: 
  • "The treatment of advanced cutaneous T-cell lymphoma remains a complex and challenging unmet medical need.
  • Each year, thousands of patients are diagnosed with CTCL, a debilitating orphan disease with no single standard of care.
  • "The BLA filing for denileukin diftitox marks the first of our pipeline candidates to be submitted for FDA approval."
  • I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.