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.
