By Chris Wack
Pieris Pharmaceuticals Inc. said the U.S. Food and Drug Administration has granted orphan drug designation to cinrebafusp alfa for the treatment of HER2-high and HER2-low expressing gastric cancers.
The biotechnology company said it expects to begin the Phase 2 trial of cinrebafusp alfa, a 4-1BB/HER2 bispecific, later this summer.
The FDA grants orphan drug designation to promote the development of a drug that targets a condition affecting 200,000 or fewer U.S. patients annually.
Orphan drug designation provides qualifying therapies with development and commercial incentives, including FDA assistance in clinical trial design, tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years following FDA approval, in addition to other available regulatory exclusivities.
Pieris shares were up 11% to $3.93 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires