InflaRx
Yahoo Finance • last year
InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum
Multi-national, randomized, controlled adaptive Phase III study in ulcerative pyoderma gangrenosum (PG) initiated and first patient dosed in the U.S.PG is a rare and debilitating autoimmune skin disease characterized by painful ulcers that... Full story
Yahoo Finance • last year
InflaRx Reports Third Quarter 2023 Financial Results and Provides Business Update
Single ascending dose (SAD) Phase I data confirm best-in-class potential of orally available C5aR inhibitor INF904; multiple ascending dose (MAD) part ongoingSix clinical sites initiated; first patients screened in Phase III trial of vilob... Full story
Yahoo Finance • last year
InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)
MAA for vilobelimab was submitted in July MAA has been validated by EMA and is now under reviewRegulatory submission based on pivotal data from PANAMO Phase III trialCompany announces attendance at upcoming scientific and investor events... Full story
Yahoo Finance • 2 years ago
InflaRx Appoints Dr. Camilla Chong as Chief Medical Officer
Camilla Chong, M.D., joins the team with 25 years of experience in the global pharmaceutical industry in drug developmentDr. Chong to lead clinical development of InflaRx’s portfolio of C5a/C5aR inhibitors JENA, Germany, June 28, 2023 (... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients
Gohibic is now commercially available for hospitals in the U.S.Gohibic can be used under an Emergency Use Authorization (EUA) granted by the FDA for treatment of certain critically ill COVID-19 patients JENA, Germany, June 21, 2023 (GLO... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Closing of the Full Exercise of Greenshoe Option Increasing the Proceeds of the Recently Announced Public Offering of Ordinary Shares to US$46 million
JENA, Germany, April 18, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that,... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Closing of $40 Million Public Offering of Ordinary Shares
JENA, Germany, April 14, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Pricing of $40 Million Public Offering of Ordinary Shares
JENA, Germany, April 12, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the p... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Public Offering of Ordinary Shares
JENA, Germany, April 11, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that... Full story
Yahoo Finance • 2 years ago
InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients
Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune responseFDA granted EUA based on Phase III clinical trial results showing a significan... Full story
Yahoo Finance • 2 years ago
InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients
Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG) Trial size to be adapted upon interim analysis with planned total patient number between approximately 50 and 100 pati... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Amendment of Co-Development Agreement and Additional Equity Investment by Staidson in Connection with Regulatory Filing in China for Anti-C5a-Antibody for Treatment of COVID-19
InflaRx will provide access to certain clinical, manufacturing and regulatory documentation for vilobelimab to facilitate STS’s regulatory filings in ChinaSTS plans to request regulatory approval in China for its own anti-C5a-antibody BDB-... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Vilobelimab Phase III Results in Critically Ill COVID-19 Patients Published in The Lancet Respiratory Medicine
The Lancet Respiratory Medicine, a peer-reviewed journal, published the results of the PANAMO trial, one of the largest, global, 1:1 randomized, placebo-controlled Phase III studies conducted in invasively mechanically ventilated, critical... Full story
Yahoo Finance • 2 years ago
InflaRx Reports Second Quarter 2022 Financial & Operating Results
Fast Track and Orphan Drug designation for vilobelimab in pyoderma gangrenosum (PG) granted by the FDAPlans to submit EUA with the FDA for vilobelimab in critically ill COVID-19 patients announcedGrant income of €14.4 million realized duri... Full story
Yahoo Finance • 2 years ago
InflaRx Announces Plans to Apply for Emergency Use Authorization from the US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients
Completed encouraging Type B meeting with US FDAApplication for EUA planned to be submitted in Q3 2022 JENA, Germany, July 26, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing a... Full story
Yahoo Finance • 3 years ago
InflaRx Provides Development Update for Vilobelimab in Pyoderma Gangrenosum and Severe COVID-19
Orphan Drug Designation granted for treatment of pyoderma gangrenosum (PG) from US FDA and EMAProductive end-of-phase II meeting with FDA held for PG; dialogue ongoing related to Phase III program designType B meeting scheduled with FDA; d... Full story
Yahoo Finance • 3 years ago
InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients
Vilobelimab treatment results in relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (p-value=0.094), but did not show statistical significance on the pre-specified primary endpointPre-specified sensitivity analys... Full story
