FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease - InflaRx (NASDAQ:IFRX)

InflaRx N.V. (NASDAQ:IFRX) has received a corrected advice letter from the FDA regarding its Phase 3 vilobelimab program for hidradenitis suppurativa (HS).

Market News and Data brought to you by Benzinga APIs

To add Benzinga News as your preferred source on Google, click here.

InflaRx N.V. (NASDAQ:IFRX) has received a corrected advice letter from the FDA regarding its Phase 3 vilobelimab program for hidradenitis suppurativa (HS).

In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint.
But gives recommendations related to implementing the modified HiSCR (m-HiSCR).
In February, the written advice letter stated that the Agency 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 the FDA.
After the corrected advice, InflaRx believes that further development in HS is feasible.
InflaRx is currently evaluating its strategic options on developing vilobelimab in this disease space most efficiently.
The Company plans to update on its pipeline development strategy in Q2 of 2022.
Price Action: IFRX shares are up 9.17% at $2.38 during the market session on the last check Thursday.

IFRXInflaRx NV

$0.9378-3.32%

Overview

Market News and Data brought to you by Benzinga APIs

To add Benzinga News as your preferred source on Google, click here.