InflaRx Shares Rise 11% After FDA Sends Corrected Advice Letter
18 March 2022 - 1:37AM
Dow Jones News
By Chris Wack
InflaRx N.V. shares were up 11% to $2.41 Thursday after the
company said it received a corrected advice letter from the U.S.
Food and Drug Administration related to its Phase III program with
vilobelimab for the treatment of hidradenitis suppurativa.
The biopharmaceutical company said that in the letter, the FDA
no longer recommends that the company use the Hidradenitis
Suppurativa Clinical Response Score as the primary endpoint for the
chosen patient population but gives recommendations related to
implementation of the modified HiSCR.
The written advice letter received in February had stated that
the FDA recommended using the HiSCR as the primary endpoint in the
Phase III trial, which was inconsistent with the minutes from a
Type A advice meeting held between InflaRx and the FDA in the third
quarter of 2021.
In light of this corrected advice from FDA, InflaRx said it
believes that further development in hidradenitis suppurativais is
feasible. InflaRx said it is currently evaluating its strategic
options on how to most efficiently develop vilobelimab in this
disease space.
The company said it plans to update the markets on its pipeline
development strategy in the second quarter of 2022.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
March 17, 2022 10:22 ET (14:22 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
InflaRx NV (NASDAQ:IFRX)
Historical Stock Chart
From Apr 2024 to May 2024
InflaRx NV (NASDAQ:IFRX)
Historical Stock Chart
From May 2023 to May 2024