On Wednesday, H.C. Wainwright reaffirmed its Buy rating and $8.00 price target for InflaRx NV (NASDAQ:IFRX), following the European Commission's approval of the company's treatment for COVID-19 related complications.
InflaRx's Gohibic, a novel anti-C5a monoclonal antibody, has been authorized for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are also receiving systemic corticosteroids and invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.
The firm's endorsement comes after Gohibic became the first and only treatment approved in the European Union (EU) for SARS-CoV-2-induced ARDS.
This decision by the European Commission is based on positive results from the Phase 3 PANAMO trial, which involved 368 severe COVID-19 patients. The study showed a 23.9% relative reduction in 28-day all-cause mortality for patients treated with Gohibic compared to placebo.
The analysts noted "The company is considering partnering and distribution options in Europe, which would not be expected to have a meaningfully negative impact on its cash burn rate."
InflaRx has also engaged with the FDA regarding the potential full approval of Gohibic in the United States. However, the FDA has indicated that an additional study would be required for a biologics license application.
The financial performance of Gohibic has been modest, with third-quarter sales in 2024 reaching €124,000. H.C. Wainwright forecasts sales for Gohibic to grow to €0.3 million in 2024 and €1.0 million in 2025.
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