Ravulizumab

Onco360 Has Been Selected as the Sole National Specialty Pharmacy Partner for Voydeya® (danicopan)

Retrieved on: 
Monday, April 8, 2024
Immune system, PNH, Specialty pharmacy, Patient, Ravulizumab, FDA, Eculizumab, Paroxysmal nocturnal hemoglobinuria, EVH, Blood, Alexion Pharmaceuticals

LOUISVILLE, Ky., April 08, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a national pharmacy partner by Alexion Pharmaceuticals for Voydeya® (Danicopan) as a first class oral, Factor D inhibitor.

Key Points: 
  • LOUISVILLE, Ky., April 08, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a national pharmacy partner by Alexion Pharmaceuticals for Voydeya® (Danicopan) as a first class oral, Factor D inhibitor.
  • It is FDA-approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in combination with C5 inhibitor, Ultomiris® (Ravulizumab) or Soliris® (Eculizumab) for patients that experience clinically significant extravascular hemolysis (EVH).1 Voydeya® is an oral, Factor D inhibitor that acts in the alternative complement pathway of the immune system, providing control of red blood cell destruction within and outside the blood vessels.
  • “Onco360 appreciates the opportunity to partner further with the team at Alexion and become the sole national specialty pharmacy provider for Voydeya®”, said Benito Fernandez, Chief Commercial Officer.
  • “We are proud to add this first in class oral Factor D inhibitor treatment option for PNH patients.”

Xencor Sells Portion of Royalties and Milestones from Ultomiris® and Monjuvi® to OMERS Life Sciences for $215 Million

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Sale, Tafasitamab, MorphoSys, Protein engineering, Cytokine, Alexion Pharmaceuticals, Antibody, Cancer, OMERS, Ravulizumab

Under the agreements, Xencor has received a $215 million payment from OMERS.

Key Points: 
  • Under the agreements, Xencor has received a $215 million payment from OMERS.
  • OMERS has acquired royalties due to Xencor on global Ultomiris sales from July 1, 2023 onward, with annual caps beginning in 2026, and the majority of a milestone payment earned this year.
  • Xencor will also be eligible for a new Ultomiris sales-based milestone payment from OMERS.
  • OMERS has also acquired royalties on global Monjuvi sales from July 1, 2023 until OMERS has received 1.3 times the value of the Monjuvi purchase price.

Xencor Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, CLDN3, Ovarian cancer, CD28, Telephone, STEAP1, OMERS, CLDN4, Sale, Vir, ESMO, Amgen, Cytokine, Gilead Sciences, Antibody, Part, Safety, Cancer, Investment, Patient, Congress, G&A, Prostate cancer, CTA, ENPP3, CLDN6, Liver disease, Genentech, European Society for Medical Oncology, CLDN9, Tafasitamab, IND, CD3, Colorectal cancer, R, Environment, Ravulizumab, Lung cancer, PARP, Vaccine, Pharmaceutical industry, Medical imaging, Rare-earth element, Cryptocurrency, Omeros, Janssen, MorphoSys, Alexion, Astellas Pharma

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a review of recent business and clinical highlights.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a review of recent business and clinical highlights.
  • Total revenue for the third quarter ended September 30, 2023 was $59.2 million, compared to $27.3 million for the same period in 2022.
  • Decreased net loss in the third quarter of 2023 compared to 2022 is primarily due to additional income earned.
  • ET (1:30 p.m. PT) to discuss the third quarter 2023 financial results and provide a corporate update.

BioCryst R&D Day Highlights New Diversified Pipeline of First-in-Class/Best-in-Class Therapies with Five Programs Expected in Clinical Development in Next 24 Months

Retrieved on: 
Friday, November 3, 2023
GMG, BioCryst Pharmaceuticals, FDA, Research, Patient, Drug design, IgA nephropathy, Plasma, CAD, Lupus nephritis, KLK5, Genetic disorder, RESEARCH, C2, DME, Eculizumab, Infection, Injection, Skin, Diabetes, Autoantibody, Ryan Murphy, Edema, Netherton, R, Autoimmune hemolytic anemia, HAE, Kallikrein, Growth, Disease, Dehydration, Muscle weakness, Immune system, Hemolysis, Solubility, Netherton syndrome, Clinical trial, Paratriathlon, Eye, Ravulizumab, Cold agglutinin disease, PARK, IP, SPINK5, Fine chemical, Pharmaceutical industry, Vaccine

A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .

Key Points: 
  • A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .
  • The team is excited to share our approach, and our expanded pipeline of new programs, at our R&D Day,” said Jon Stonehouse, president and chief executive officer of BioCryst.
  • The disease is caused by the deficiency of a natural inhibitor (SPINK5) of KLK5, a serine protease responsible for regulating skin shedding.
  • Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections.

What’s on Your Must-Read List? If You Work in Pharma, Add Spherix Global Insights’ Generalized Myasthenia Gravis Patient Chart Audit to that List

Retrieved on: 
Thursday, August 10, 2023
Cholinesterase, GMG, Efgartigimod alfa, Myasthenia gravis, Neurology, Genentech, UCB, Patient, Physician, Ocular myasthenia, Diagnosis, Neonatal Fc receptor, Horizon, Cholinesterase inhibitor, Pharmaceutical industry, Eculizumab, Ravulizumab

US-based neurologists completed this HIPAA compliant, online chart audit survey among 607 patients with gMG using information exclusively found in their practice’s electronic medical records.

Key Points: 
  • US-based neurologists completed this HIPAA compliant, online chart audit survey among 607 patients with gMG using information exclusively found in their practice’s electronic medical records.
  • Spherix’s sweeping research paints a picture of the gMG treatment journey and the patients who are coping with this devastating neuromuscular condition.
  • The RealWorld Dynamix chart audit study was completed by nearly 150 neurologists and neuromuscular specialists across all regions of the US.
  • Patient charts were submitted by general neurologists seeing as few as 10-20 gMG patients and specialists managing more than 100 gMG patients.

Xencor Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Janssen, G&A, Atopic dermatitis, CLDN6, European Society for Medical Oncology, Congress, Patient, Investment, STEAP1, R, NK, NMOSD, European Congress of Mathematics, Manuscript, Vir, EULAR, IND, Safety, CD3, Amgen, ESMO, Cancer, AMG, Antibody, Psoriasis, Ovarian cancer, Pembrolizumab, PARP, Renal cell carcinoma, Progression-free survival, CD28, Telephone, Part, Janssen Pharmaceuticals, Notifiable disease, Cytokine, Neuromyelitis optica spectrum disorder, European Society of Gynaecological Oncology, Tumor microenvironment, Vaccine, Pharmaceutical industry, Cryptocurrency, EU, Alexion, Ravulizumab, MorphoSys, Astellas Pharma

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the second quarter ended June 30, 2023 and provided a review of recent business and clinical highlights.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the second quarter ended June 30, 2023 and provided a review of recent business and clinical highlights.
  • In the second quarter of 2023, Xencor earned $11.2 million of royalty revenue from Alexion on net sales of Ultomiris.
  • Decreased net loss in the second quarter of 2023 compared to 2022 is primarily due to additional income and interest earned.
  • ET (1:30 p.m. PT) to discuss the second quarter 2023 financial results and provide a corporate update.

Muscular Dystrophy Association Celebrates FDA Approval of UCB’s RYSTIGGO for the Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Tuesday, June 27, 2023
Communication, US Food Sovereignty Alliance, Disease, MuSK protein, Doctor of Philosophy, Thymectomy, GMG, Efgartigimod alfa, Fc receptor, Antibody, Immunoglobulin G, Enzyme inhibitor, Ravulizumab, UCB, Patient, MG, Muscular Dystrophy Association, Acetylcholine receptor, Neonatal Fc receptor, MDA, FDA, Pharmaceutical industry, Vaccine, Eculizumab

New York, June 27, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Key Points: 
  • New York, June 27, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
  • RYSTIGGO is the only FDA-approved treatment in adults for both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG, and will be administered as an injection for subcutaneous infusion.
  • Although treatment with RYSTIGGO will not cure gMG, it could lead to functional improvements that improve the daily life of individuals with gMG.
  • “Rystiggo is a welcome addition to the targeted therapeutic options available for the treatment of generalized myasthenia gravis,” said Sharon Hesterlee, Ph.D., Chief Research Officer, MDA.

Xencor Reports First Quarter 2023 Financial Results

Retrieved on: 
Monday, May 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ICOS, AACR, CD28, European Alliance of Associations for Rheumatology, Cancer, ENPP3, American Association for Cancer Research, Janssen, TACSTD2, NMOSD, Research, CLDN6, Part, Genentech, Antibody, AstraZeneca, CEACAM5, ASCO, Congress, Patient, STEAP1, Ipilimumab, Colorectal cancer, Vir, EULAR, Cytokine, PD-1, Neuromyelitis optica spectrum disorder, Ovarian cancer, European Alliance, IND, Tumor microenvironment, Roche, Vaccine, Pharmaceutical industry, Cryptocurrency, Video game, EU, MorphoSys, Astellas Pharma, Rheumatology, Alexion, Ravulizumab

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the first quarter ended March 31, 2023 and provided a review of recent business and clinical highlights.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the first quarter ended March 31, 2023 and provided a review of recent business and clinical highlights.
  • In the first quarter of 2023, Xencor earned $10.5 million of royalty revenue from Alexion on net sales of Ultomiris.
  • Revenues for the first quarter ended March 31, 2023 were $19.0 million, compared to $85.5 million for the same period in 2022.
  • ET (1:30 p.m. PT) to discuss the first quarter 2023 financial results and provide a corporate update.

One Year Post-Launch of Argenx's Vyvgart for gMG, US Neurologists Confused on Best Approach to Treatment Dosing Schedules, According to Spherix Global Insights

Retrieved on: 
Friday, February 24, 2023
Neurology, PDUFA, Genentech, UCB, Research, Neonatal Fc receptor, NMOSD, Patient, NASA RealWorld-InWorld Engineering Design Challenge, Inebilizumab, Market, Janssen, GMG, Hatred, Launch, Nursing, Pharmaceutical industry, Efgartigimod alfa, Ravulizumab, EU

EXTON, Pa., Feb. 24, 2023 /PRNewswire/ -- Argenx's launch of Vyvgart (efgartigimod) has been a success, with global first-year revenue of ~$400 million USD. As the second biologic approved for generalized myasthenia gravis (gMG) and the first neonatal Fc receptor (FcRn) blocker, Vyvgart's novel and targeted mechanism of action has resonated with HCPs. Indeed, neurologists and neuromuscular specialists surveyed by Spherix Global Insights consider Vyvgart to address a substantial unmet in the treatment of this chronic, rare autoimmune condition.

Key Points: 
  • Indeed, neurologists and neuromuscular specialists surveyed by Spherix Global Insights consider Vyvgart to address a substantial unmet in the treatment of this chronic, rare autoimmune condition.
  • Despite these positive perceptions of argenx's brand, surveyed respondents (n=69) remain less confident in Vyvgart's dosing profile.
  • Interestingly, even with increased experience among neurologists, half continue to report uncertainty as to when to re-dose patients after the first Vyvgart treatment cycle.
  • Indeed, when probed unaided on Vyvgart's biggest disadvantages, two in five offered its dosing profile as a leading disadvantage.

Dermatomyositis Market is Expected to Showcase Significant Growth at a CAGR of 11% During the Study Period (2019-2032), Predicts DelveInsight

Retrieved on: 
Tuesday, January 24, 2023
Therapy, Calcinosis cutis, EU4, CSL Behring, Biotechnology, Dermatomyositis, AstraZeneca, United Kingdom, LAS, Incidence, Diagnosis, Small joint manipulation, ODD, DM, US FDA, Juvenile dermatomyositis, Horizon Therapeutics, Ravulizumab, Myositis, JDM, Patient, Alexion Pharmaceuticals, Risk, Inflammation, Pharmaceutical industry, Dietary supplement, Pfizer

LAS VEGAS, Jan. 24, 2023 /PRNewswire/ -- DelveInsight's Dermatomyositis Market Insights report includes a comprehensive understanding of current treatment practices, dermatomyositis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

Key Points: 
  • As per DelveInsight analysis, the dermatomyositis market size in the 7MM was approximately USD 175 million in 2021.
  • According to the assessment done by DelveInsight, the estimated total dermatomyositis prevalent population in the 7MM was approximately 61K in 2021.
  • The underlying cause of dermatomyositis is unknown; however, evidence suggests that genetic, immune, and environmental factors all play a role.
  • The dermatomyositis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: