00:00HLB has applied for formal marketing approval of its bile duct cancer drug, lirifugratinib, in Europe with the EMA, following
00:08its U.S. FDA filing.
00:11The clinical results stand out. Tumors shrank in 46.5% of patients, and median overall survival reached 22.8
00:19months. One more point matters more.
00:21The FDA's target action date is the 25th of this month, now just days away.
00:27HLB is also running a global Phase II trial in solid tumors, with FGFR2 gene alterations beyond bile duct cancer.
00:35All eyes are on what the FDA decides on September 25th, and whether HLB's global drug bid will pay off.
