Shares in Moleculin Biotech Inc (NASDAQ:MBRX) shot up over 34% in pre-market deals as it received welcome FDA news.
The Food and Drug Administration (FDA) has authorised the group to begin clinical trials of candidate Annamycin for relapsed or refractory Acute Myeloid Leukemia (AML).
It came after the FDA completed its safety review of information and a proposed protocol submitted by Moleculin in an Investigational New Drug application (IND).
"This represents a tremendous milestone for Moleculin," said Walter Klemp, chairman and chief executive at Moleculin.
"Our primary focus has been to get Annamycin back into the clinic so we can begin optimizing the dosing of the drug as the next step in evaluating its potential to become the first 2nd line therapy suitable for the majority of relapsed or refractory AML patients. It is a thrill to now refer to Moleculin as a 'clinical stage' company."
Annamycin is the group's lead candidate. It also has two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system.