Onconova Therapeutics, Inc. (NASDAQ:ONTX) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On December 21, 2020, Onconova Therapeutics, Inc. (“Onconova” or the “Company”) issued a press release announcing that it has received permission from the U.S. Food and Drug Administration (“FDA”) for a Phase 1 study to proceed under an Investigational New Drug application that the Company submitted for its product candidate ON 123300. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information disclosed under this Item 7.01 (including Exhibit 99.1) 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 incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On December 18, 2020, Onconova received permission from the FDA for a Phase 1 study to proceed under an Investigational New Drug application that the Company submitted for its product candidate ON 123300. Following Institutional Review Board approval, the Company plans to begin a Phase 1 study of ON 123300 in the United States.
Item 9.01 Financial Statements and Exhibits.
|Press release of Onconova Therapeutics, Inc. issued on December 21, 2020|
Onconova Therapeutics, Inc. Exhibit
EX-99.1 2 tm2039009d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Onconova Therapeutics Announces FDA Permission for Study to Proceed Under its Investigational New Drug Application for Multi- kinase CDK4/6 Inhibitor ON 123300 Company affirms plans to begin enrollment of patients with HR+ HER2- metastatic breast cancer and other tumors in U.S. Phase 1 trial in the first half of 2021 NEWTOWN,…
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About Onconova Therapeutics, Inc. (NASDAQ:ONTX)
Onconova Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company operates through the identification and development of oncology therapeutics segment. It is focused on discovering and developing small molecule drug candidates to treat cancer. The Company has created a targeted anti-cancer agents designed to work against specific cellular pathways that are important to cancer cells. It has over three clinical-stage product candidates and various preclinical programs that target kinases, cellular metabolism or cell division in preclinical development. The Company’s lead product candidate, rigosertib, is being tested in both intravenous (IV) and oral formulations as a single agent, and the oral formulation is also being tested in combination with azacitidine, in clinical trials for patients with myelodysplastic syndromes (MDS), and related cancers. Its other product candidates include Briciclib and Recilisib.