InflaRx

InflaRx is shifting its focus from immunodermatology to complement-mediated kidney diseases and is positioning oral izicopan as its lead program, particularly for ANCA-associated vasculitis (AAV). The company plans a Phase IIb study in AAV for early 2025, is in talks with the FDA about efficacy endpoints, and sees market opportunities after the withdrawal of TAVNEOS in Europe. InflaRx reports financing through 2029 following a $150 million round, but continues to cite risks such as reaching agreement with the FDA, manufacturing preparations, and potential additional capital needs for later stages. » Więcej na de.investing.com

InflaRx is shifting its focus to ANCA-associated vasculitis and other kidney diseases and sees a larger market opportunity due to safety issues with avacopan. INF904 is presented as an orally available C5aR1 inhibitor with improved pharmacokinetics and a favorable liver safety profile compared with avacopan. Vilobelimab remains planned as a second, more rapidly available option for remission induction. The company is in discussions with the FDA about study design and endpoints and plans a phase II study with INF904; clinical and regulatory hurdles remain. » Więcej na de.investing.com

InflaRx has opened talks with the EMA on possible approval routes in Europe for the anti‑C5a antibody Vilobelimab and the oral C5aR inhibitor Izicopan to treat ANCA‑associated vasculitis (AAV). The review follows the CHMP recommendation to withdraw the approval of Tavneos and aims to clarify the most efficient development path to make C5a/C5aR inhibitors available to patients. InflaRx describes Vilobelimab as phase‑3 ready after completion of two phase‑2 trials; phase‑2 planning for Izicopan will continue regionally. According to InvestingPro the stock has recently risen sharply, but the company reports a solid liquidity position with more cash than debt. » Więcej na de.investing.com

InflaRx placed 75,000,000 common shares at $2.00 each, generating gross proceeds of $150 million before fees. The company said it will use the net proceeds to advance its product pipeline, for working capital and for general corporate purposes; new and existing institutional investors participated in the offering. According to InvestingPro, InflaRx is currently overvalued relative to its fair-value estimate and had negative free cash flow of $41.6 million over the past twelve months. » Więcej na de.investing.com

InflaRx announces phase‑2 planning for the oral C5a receptor inhibitor izicopan in ANCA‑associated vasculitis (AAV) and is exploring accelerated development pathways. The company aims to generate proof‑of‑concept data for izicopan in additional complement‑mediated kidney diseases (aHUS, IgAN, C3G) in open‑label studies; initial clinical data are expected in 2027. Plans include a pharmacokinetic bridging study in China later this year, a capital‑markets day in summer 2026 and a webcast on May 8 to discuss strategy. InflaRx is pursuing a guaranteed capital increase of 75 million common shares at $2.00 each, with closing expected on May 7; proceeds are intended to fund programs to key milestones and operations through 2029. » Więcej na de.investing.com