InflaRx N.V. - IFRX STOCK NEWS

InflaRx N.V. (Nasdaq: IFRX) has initiated a randomized, double-blind, placebo-controlled Phase I trial for its orally administered C5aR inhibitor, INF904. The study aims to evaluate the drug's safety, tolerability, and pharmacokinetics in approximately 62 healthy volunteers. Previously, preclinical studies indicated INF904's potential to inhibit C5a signaling without significant toxicity. This trial marks a significant step in addressing complement-mediated chronic diseases.

InflaRx N.V. (Nasdaq: IFRX) recently earned both Orphan Drug and Fast Track designations for vilobelimab as a treatment for critically ill COVID-19 patients, alongside an Emergency Use Authorization (EUA) submission to the FDA. Positive results from the PANAMO Phase III study were published in The Lancet Respiratory Medicine. The company reported €93.2 million in cash and securities, projected to fund operations until year-end 2024. Financial results showed reduced net loss of €21.5 million for the nine months ending September 30, 2022, an improvement from €33 million in the same period last year.

InflaRx (Nasdaq: IFRX) has submitted a request for Emergency Use Authorization (EUA) for vilobelimab, aimed at treating critically ill COVID-19 patients. The EUA request is based on the results of the PANAMO Phase III trial, published in The Lancet Respiratory Medicine. The FDA has also granted Fast Track designation for vilobelimab, which allows for expedited development and review. The proprietary name ‘Gohibic’ has been conditionally accepted by the FDA, marking significant progress in making this therapy available to patients.

InflaRx N.V. (Nasdaq: IFRX) announced its participation in several upcoming conferences focused on anti-inflammatory therapeutics. CEO Prof. Niels C. Riedemann will present a corporate overview at the H.C. Wainwright Annual Global Investment Conference on September 14, 2022, and engage in a podium discussion for World Sepsis Day on September 16. Additionally, Chief Scientific Officer Prof. Renfeng Guo will present on September 28 at the Complement Drug Development Summit, and Prof. Alexander Vlaar will showcase a poster on October 24 at the ESICM Annual Congress.

InflaRx N.V. (Nasdaq: IFRX) announced the publication of PANAMO trial results in The Lancet Respiratory Medicine, a study focused on vilobelimab treatment for critically ill COVID-19 patients on mechanical ventilation.

The trial demonstrated a 23.9% reduction in 28-day all-cause mortality for vilobelimab compared to placebo. Although the primary analysis yielded a p-value of 0.0941, alternative analyses confirmed significant survival benefits (p-values <0.05). The company plans to request emergency use authorization from the FDA by Q3 2022, reinforcing the treatment's potential in this high-risk patient group.

InflaRx N.V. (Nasdaq: IFRX) has secured Fast Track and Orphan Drug designations from the FDA for vilobelimab to treat pyoderma gangrenosum (PG) and plans to submit an EUA for critically ill COVID-19 patients. The company reported €14.4 million in grant income during Q2 2022, maintaining €91.8 million in cash and equivalents to fund operations until late 2024. The net loss for the first half of 2022 was €13.5 million, a decrease from €20.9 million in 2021, while R&D expenses rose to €21.7 million due to ongoing clinical studies.

InflaRx (Nasdaq: IFRX) announced it will submit an Emergency Use Authorization (EUA) request for vilobelimab, an anti-C5a monoclonal antibody, after positive discussions with the FDA. The company plans to file the application by the end of Q3 2022, following encouraging results from the Phase III PANAMO study, which showed a 23.9% relative reduction in 28-day all-cause mortality in critically ill COVID-19 patients. With rising COVID-19 cases, the urgency for effective treatments remains high.

InflaRx N.V. (Nasdaq: IFRX) announced that the U.S. FDA granted Fast Track designation for its monoclonal antibody vilobelimab in treating ulcerative pyoderma gangrenosum (PG). This designation follows the orphan drug designation earlier granted by both the FDA and EMA. In a Phase IIa study, 85.7% of patients in the high-dose cohort showed complete ulcer closure. The Fast Track will expedite FDA interactions, facilitating faster review after successful Phase III completion, addressing a significant unmet medical need.

InflaRx N.V. (Nasdaq: IFRX) announced that its monoclonal anti-C5a antibody, vilobelimab, received orphan drug designation for treating pyoderma gangrenosum (PG) from both FDA and EMA. The company held a fruitful end-of-phase II meeting with the FDA to advance toward a Phase III program for PG. Additionally, a Type B meeting with the FDA is scheduled to discuss emergency use authorization for vilobelimab in severe COVID-19, while ongoing discussions with EMA are also in progress.