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PIERIS PHARMACEUTICALS, INC.

(PIRS)
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Pieris Pharmaceuticals Gets Orphan Drug Designation for Gastric Cancer Treatment

06/24/2021 | 06:50am EDT

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

06-24-21 0850ET

Stocks mentioned in the article
ChangeLast1st jan.
DJ INDUSTRIAL -0.42% 34935.47 Delayed Quote.14.13%
PIERIS PHARMACEUTICALS, INC. 1.75% 3.48 Delayed Quote.39.20%
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Financials (USD)
Sales 2021 21,8 M - -
Net income 2021 -55,5 M - -
Net Debt 2021 - - -
P/E ratio 2021 -3,87x
Yield 2021 -
Capitalization 220 M 220 M -
Capi. / Sales 2021 10,1x
Capi. / Sales 2022 5,97x
Nbr of Employees 117
Free-Float 88,4%
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Mean consensus BUY
Number of Analysts 4
Last Close Price 3,48 $
Average target price 8,50 $
Spread / Average Target 144%
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Managers and Directors
Stephen S. Yoder President, Chief Executive Officer & Director
Thomas Bures Treasurer & Vice President-Finance
James Arthur Geraghty Chairman
Hitto Kaufmann Chief Scientific Officer & Senior Vice President
Michael S. Richman Independent Director
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