NovelMed Receives FDA IND Approval for NM8074 (Ruxoprubart), the First Anti-Bb Alternative Pathway Blocker for Treating Primary Immunoglobulin A Nephropathy (IgAN): A Renal Disorder
02 déc. 2024 08h30 HE
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NovelMed Therapeutics Inc
--- The United States FDA Clears Initiation of a Phase II Efficacy Trial in Immunoglobulin A Nephropathy (IgAN) Patients: a renal disorder Up to 50% of IgAN patients with persistent proteinuria...
FDA Approves Phase II Clinical Trial for Ruxoprubart in ANCA Associated Vasculitis (AAV) – a Chronic Rare Disease in Nephrology
17 juin 2024 08h30 HE
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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)
15 avr. 2024 08h30 HE
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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
12 févr. 2024 08h30 HE
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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
08 janv. 2024 08h30 HE
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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
30 oct. 2023 08h00 HE
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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
05 juin 2023 08h00 HE
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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
06 mars 2023 08h30 HE
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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)
30 janv. 2023 08h30 HE
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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...