Pieris Pharmaceuticals Shares Rise 19% After Getting Orphan Drug Status
By Chris Wack
Pieris Pharmaceuticals Inc. shares were up 19% to $4.21 Thursday
after the company 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
Volume for the stock was 23 million shares at 1:30 p.m. ET,
compared with a 65-day average volume of 9.4 million shares. The
stock hit a 52-week high of $5.09 on May 26.
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
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
June 24, 2021 13:52 ET (17:52 GMT)
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