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InflaRx Hosts R&D Event Highlighting the Promise of INF904
05 juin 2024 12h00 HE | InflaRx N.V.
Thought leaders in complement inhibition, chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) provide compelling new insights into the strong development rationales, potential...
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Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment
12 févr. 2024 08h30 HE | NovelMed Therapeutics Inc
FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH.Ruxoprubart is an Anti-Bb antibody that selectively blocks the alternative pathway while maintaining the intactness...
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InflaRx Reports Second Quarter 2023 Financial Results & Operating Update
10 août 2023 07h30 HE | InflaRx N.V.
• Quarter highlighted by the Emergency Use Authorization (EUA) and commercial launch of Gohibic (vilobelimab) in the United States • Oral C5aR inhibitor INF904 progressing in...
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NovelMed Phase I Clinical Trial Shows Inhibition of the Alternative Pathway and Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody NM3086 for PNH Patients
05 juin 2023 08h00 HE | Novelmed Therapeutics Inc
Phase I Clinical Trial in healthy subjects shows that NM3086 was safe and well tolerated at all doses (0.1 to 20 mg/kg) in six cohorts. Total AP inhibition was achieved through all cohorts and the...
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InflaRx Reports First Quarter 2023 Financial and Operating Results and Provides Business Update
11 mai 2023 07h30 HE | InflaRx N.V.
Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patientsGohibic planned to be available to...
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InflaRx Reports Full Year 2022 Financial and Operating Results
22 mars 2023 07h30 HE | InflaRx N.V.
Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol...
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Anti-Properdin Antibody (NM3086) Demonstrates Efficacy in a Primate Model of Wet-AMD and Dry-AMD
06 mars 2023 08h30 HE | Novelmed Therapeutics Inc
---Single therapy for multiple forms of Age-Related Macular Degeneration (AMD) NM3086 is a highly potent Alternative Pathway (AP) blocker that does not affect the Classical Pathway (CP).Dysfunction...
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Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients (Rare Disease)
30 janv. 2023 08h30 HE | Novelmed Therapeutics Inc
-- FDA Clears Initiation of Efficacy Trial in aHUS (Atypical Hemolytic Uremic Syndrome) Patients An Efficacy Trial in Adult aHUS Patients Who Are Naïve to Complement Inhibitor Therapy...
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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
05 janv. 2023 07h30 HE | InflaRx N.V.
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...
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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
21 déc. 2022 07h30 HE | InflaRx N.V.
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...