Item 8.01 Other Events.

On July 30, 2012, Genta Incorporated (the "Company") announced that it has received formal notice from the drug regulatory authority of the People's Republic of China (SFDA) that the Company has received approval to start clinical trials with tesetaxel, its lead clinical compound, in China.

SFDA has requested and approved a dose-ranging study of the combination of capecitabine plus tesetaxel, up to and including the dose used in a pivotal randomized trial (known as TESEGAST), as well as subsequent participation by China in the TESEGAST study. The TESEGAST study is designed to evaluate the safety and activity of tesetaxel plus capecitabine compared with capecitabine plus placebo in patients with advanced gastric cancer. Gastric cancer is the second most common tumor type in China.