Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment
February 12, 2024 08:30 ET
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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...
InflaRx Reports Second Quarter 2023 Financial Results & Operating Update
August 10, 2023 07:30 ET
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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...
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
June 05, 2023 08:00 ET
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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...
InflaRx Reports First Quarter 2023 Financial and Operating Results and Provides Business Update
May 11, 2023 07:30 ET
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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...
InflaRx Reports Full Year 2022 Financial and Operating Results
March 22, 2023 07:30 ET
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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...
Anti-Properdin Antibody (NM3086) Demonstrates Efficacy in a Primate Model of Wet-AMD and Dry-AMD
March 06, 2023 08:30 ET
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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...
Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients (Rare Disease)
January 30, 2023 08:30 ET
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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...
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
January 05, 2023 07:30 ET
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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...
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
December 21, 2022 07:30 ET
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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...
InflaRx Initiates First-in-Human Study with Small Molecule C5aR Inhibitor INF904
November 09, 2022 07:40 ET
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InflaRx N.V.
Randomized, double-blind, placebo-controlled Phase I trial of orally administered complement inhibitor INF904 initiatedStudy designed as single ascending dose to determine safety, tolerability and...