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Earlier today, InflaRx N.V. (NASDAQ: IFRX) announced plans to apply for Emergency Use Authorization (EUA) for vilobelimab for critically ill COVID-19 patients, following encouraging interactions with the FDA at a recently held Type B meeting.
Vilobelimab is InflaRx’s novel intravenously administered first-in-class anti-C5a monoclonal antibody that selectively binds to free complement activation factor C5a.
At the FDA meeting, the company discussed in detail the previously announced data from the Phase 3 part of the PANAMO study.
Results showed a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (vilobelimab 31.7% vs. placebo 41.6%). In Western European countries (n=209), there was a relative reduction in 28-day all-cause mortality of 43%.
InflaRx received guidance from the FDA on deliverables related to its planned submission for EUA, which is expected in 3Q22.
HC Wainwright anticipates a launch in 2024 for vilobelimab for COVID-19 patients with sales of $14 million that year and $135 million in 2028.
The analyst reiterates the Buy rating with a price target of $7.
Price Action: IFRX shares are up 46.40% at $2.04 during the market session on the last check Tuesday.
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