IFRX InflaRx NV

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)

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