Pieris Pharmaceuticals Gets Orphan Drug Designation for Gastric Cancer Treatment
June 24 2021 - 9:04AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
June 24, 2021 08:50 ET (12:50 GMT)
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