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...
BioCryst Reports First Quarter 2020 Financial Results and Upcoming Key Milestones
May 06, 2020 07:00 ET
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BioCryst Pharmaceuticals, Inc.
—Berotralstat approval/launch timelines in U.S., Japan, EU remain on track— —Early clinical data supports BCX9930 as oral monotherapy for complement-mediated diseases— —Patient dosing underway in...
BioCryst Reports Data From Phase 1 Trial of BCX9930 and Announces Plans to Advance Program Into Proof of Concept Study in PNH Patients
October 28, 2019 06:59 ET
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BioCryst Pharmaceuticals, Inc.
—Phase 1 data showed rapid, sustained and >95% inhibition of alternative pathway of complement system with 100 mg of oral BCX9930 BID— —BCX9930 safe and generally well tolerated— —Part 1 SAD and...
Biocryst Begins Enrollment of Phase 1 Trial of BCX9930, an Oral Factor D Inhibitor for Complement-Mediated Diseases
June 27, 2019 16:15 ET
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BioCryst Pharmaceuticals, Inc.
—Data expected in Q4 2019— —BCX9930 showed high potency, specificity, suppression of hemolysis and wide safety margin in preclinical studies— RESEARCH TRIANGLE PARK, N.C., June 27, 2019 (GLOBE...
Apellis Pharmaceuticals Completes Enrollment of Phase 3 APL-2 (pegcetacoplan) Head-to-Head Study in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Eculizumab
June 27, 2019 07:39 ET
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Apellis Pharmaceuticals, Inc.
CRESTWOOD, Ky. and WALTHAM Mass., June 27, 2019 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused on the development of novel...
Apellis Pharmaceuticals Announces Collaboration with SFJ Pharmaceuticals® for APL-2 in Hematologic Indications
February 28, 2019 10:00 ET
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Apellis Pharmaceuticals, Inc.
Apellis to receive up to $120 million in upfront and near-term milestone payments, with the potential for additional payments subject to mutual agreement Apellis retains exclusive worldwide...