Item7.01. Regulation FD Disclosure.

On January 10, 2023, Qualigen Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to its lead drug candidate, QN-302, for the indication of pancreatic cancer. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01 (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall the information in this Item 7.01 (including Exhibit 99.1 attached hereto) be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.




Item 8.01. Other Events.

As described in Item 7.01 of this Current Report on Form 8-K, the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company's lead drug candidate, QN-302, for the indication of pancreatic cancer. QN-302 is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells.

Item 9.01. Financial Statements and Exhibits.



(d) Exhibits

Exhibit No.   Description

99.1            Press Release dated January 10, 2023 issued by Qualigen
              Therapeutics, Inc.

104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document)

© Edgar Online, source Glimpses