FDA Approves Phase II Clinical Trial for Ruxoprubart in ANCA Associated Vasculitis (AAV) – a Chronic Rare Disease in Nephrology
June 17, 2024 08:30 ET
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NovelMed Therapeutics Inc
-- The United States FDA Clears Initiation of Efficacy Trial in Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) Patients A Phase II, Efficacy Trial in adult AAV patients has...
The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)
April 15, 2024 08:30 ET
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NovelMed Therapeutics Inc
The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.The ODD provides NM5072 with a range of benefits,...
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...
USAN Approves Generic Name “Ruxoprubart” for NM8074, an Antibody Therapy focused on Complement-Mediated Diseases
January 08, 2024 08:30 ET
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NovelMed Therapeutics Inc
The USAN Council has officially adopted "Ruxoprubart (Ruk”soe proo' bart)" as the generic name for NM8074, marking a significant milestone in the drug development process.Ruxoprubart is an...
NovelMed Commences Phase II Trial for Anti-Bb Antibody (NM8074) in Treatment-Naïve PNH Patients: A Glimpse into the PNH Study Progress
October 30, 2023 08:00 ET
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NovelMed Therapeutics Inc
The Phase I healthy trial revealed that NM8074 effectively blocked the alternative pathway (AP) and AP-mediated C3b deposition without affecting the classical pathway (CP). Importantly, NM8074 did not...
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...
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...