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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) March 18, 2024

 

 

 

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Nevada

(State or other jurisdiction of incorporation)

 

001-38174   27-3425913
(Commission File Number)   (IRS Employer Identification No.)

 

11 Commerce Drive, 1st Floor, Cranford, NJ   07016
(Address of principal executive offices)   (Zip Code)

 

Registrant's telephone number, including area code (908) 967-6677

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

 

Trading Symbol(s)

 

Name of each exchange

on which registered

Common stock, $0.001 par value   CTXR   The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 8.01 Other Events.

 

On March 18, 2024, Citius Pharmaceuticals, Inc. issued a press release to announce that the U.S. Food and Drug Administration has accepted the resubmission of the Company’s Biologics License Application for LYMPHIR™ (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

  

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The following exhibit is filed herewith:

 

Exhibit    
No.   Description
99.1   Press Release dated March 18, 2024.

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  

       
      CITIUS PHARMACEUTICALS, INC.
       
       
       
Date: March 18, 2024   /s/ Leonard Mazur
      Leonard Mazur
      Chairman and Chief Executive Officer