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May 19, 2025 11:48 ET | Source: NovelMed Therapeutics Inc

NovelMed’s Phase II Data in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Ruxoprubart Shows Best-in-Class Efficacy as Monotherapy

--- Ruxoprubart (NM8074) met all clinical endpoints, offering a safe, differentiated treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare...
May 19, 2025 08:30 ET | Source: NovelMed Therapeutics Inc

Phase II Data in Treatment-Naïve Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Ruxoprubart Demonstrates Best-in-Class Efficacy as Monotherapy

--- Ruxoprubart (NM8074) met all clinical endpoints, offering a safe, differentiated treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria (PNH) is a...
February 24, 2025 10:11 ET | Source: NovelMed Therapeutics Inc

United States FDA Approves NM8074 (Ruxoprubart) IND for Treating Dermatomyositis (DM): A Chronic Inflammatory Disorder of the Skin

--- The United States FDA Approves the Initiation for Phase II Efficacy Trial in Dermatomyositis (DM) Patients: A Skin & Muscle Disorder DM is an immune-mediated myopathy characterized by...
December 02, 2024 08:30 ET | Source: NovelMed Therapeutics Inc

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

--- 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...
June 17, 2024 08:30 ET | Source: NovelMed Therapeutics Inc

FDA Approves Phase II Clinical Trial for Ruxoprubart in ANCA Associated Vasculitis (AAV) – a Chronic Rare Disease in Nephrology

-- 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...
February 12, 2024 08:30 ET | Source: NovelMed Therapeutics Inc

Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment

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...
January 08, 2024 08:30 ET | Source: NovelMed Therapeutics Inc

USAN Approves Generic Name “Ruxoprubart” for NM8074, an Antibody Therapy focused on Complement-Mediated Diseases

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...