SYNDAX PHARMACEUTICALS, INC. (NASDAQ:SNDX) Files An 8-K Other EventsItem 8.01. Other Events.
On October5, 2017, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it received notice from Kyowa Hakko Kirin Co., Ltd. (“Kyowa Hakko Kirin”), the exclusive sublicensee of entinostat in Japan and Korea, that Kyowa Hakko Kirin enrolled the first Japanese patient in a randomized, double-blind, placebo-controlled, pivotal Phase 2 trial of entinostat in combination with exemestane for the treatment of advanced or recurrent hormone receptor positive, human epidermal growth factor receptor two negative breast cancer. In accordance with the terms of the license agreement dated December19, 2014 between the Company and Kyowa Hakko Kirin, Kyowa Hakko Kirin will pay the Company a $5 million milestone payment within 30 days of enrollment.
A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description |
99.1 | Press Release, dated October 5, 2017 |
Syndax Pharmaceuticals Inc ExhibitEX-99.1 2 d468957dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Syndax Announces Dosing of First Patient in Pivotal Trial of Entinostat for the Treatment of Advanced or Recurrent Breast Cancer in Japan by Partner Kyowa Hakko Kirin – Enrollment of First Patient Triggers $5 Million Milestone Payment to Syndax – WALTHAM,…To view the full exhibit click here
About SYNDAX PHARMACEUTICALS, INC. (NASDAQ:SNDX)
Syndax Pharmaceuticals, Inc (Syndax) is a clinical stage biopharmaceutical company focused on developing a pipeline of combination therapies in multiple cancer indications. The Company’s product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from its Phase IIb clinical trial, ENCORE 301, is being evaluated in a Phase III clinical trial for advanced hormone receptor positive breast cancer. It is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body’s immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase Ib/II clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer.