Namilumab

Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis

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星期四, 四月 25, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Pain, Sarcoidosis, Inflammation, Granuloma, Research, GM-CSF, Disease, Patient, Fatigue, Fibrosis, Lung, Namilumab, Clinical trial, Prednisone, Methotrexate, Pharmaceutical industry

Roivant (Nasdaq: ROIV) and Kinevant Sciences , a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung).

Key Points: 
  • Roivant (Nasdaq: ROIV) and Kinevant Sciences , a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung).
  • Potentially supportive of registration, RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to enroll a minimum of 100 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatment options.
  • “Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis.
  • Thus, namilumab has the potential to be the only well-tolerated and effective therapy for sarcoidosis, as well as the first therapy approved specifically for pulmonary sarcoidosis.

Kinevant Sciences Announces First Patient Dosed in Phase 2 Study of Namilumab for the Treatment of Pulmonary Sarcoidosis (RESOLVE-Lung)

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星期四, 十一月 17, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Organ dysfunction, Patient, Trial of the century, Cytokine, Failure, University of Florida, Sarcoidosis, Pathology, GM, Cough, OLE, Drug development, Lymph, Transplant, Disease management, Quality of life, Medicine, Death, Granuloma, Pulmonary hypertension, Safety, Arthritis, Inflammation, Disease, Pain, Roivant Sciences, University, GM-CSF, Namilumab, Fatigue, Vaccine, Pharmaceutical industry

This Phase 2 clinical study will evaluate the efficacy and safety of Kinevants namilumab for the treatment of pulmonary sarcoidosis.

Key Points: 
  • This Phase 2 clinical study will evaluate the efficacy and safety of Kinevants namilumab for the treatment of pulmonary sarcoidosis.
  • The study will assess the efficacy and safety of namilumab in approximately 100 patients with pulmonary sarcoidosis across a 26-week treatment period.
  • All patients that complete the 26-week double-blind treatment period will be eligible to participate in a 28-week OLE treatment period on namilumab.
  • Kinevant is initially focusing on sarcoidosis with an anti-GM-CSF monoclonal antibody, namilumab, currently being evaluated in the Phase 2 RESOLVE-Lung study in patients with pulmonary sarcoidosis.

Roivant Sciences Reports Financial Results for the First Quarter Ended June 30, 2022 and Provides Business Update

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星期一, 八月 15, 2022
MDS, Psoriasis, MG, Transfusion-dependent anemia, Roivant Sciences, Drug discovery, SLE, Industry, GLOBE, Senior, EASI, NEW, R, Dermatomyositis, Merck Serono, Prescription, Tobacco, Achievement, IQVIA, Namilumab, Phase 1, Patient, Vant (band), TED, Calendar, Hidradenitis suppurativa, Company, Alopecia areata, SG, Neurology, IGA, Japan Tobacco, Safety, Atopic dermatitis, Sarcoidosis, Research, JAK1, AD, Ulcerative colitis, TYK2, MAAC, Graves' ophthalmopathy, EDT, Pharmaceutical industry, Animal, Immunology, Pfizer

First Quarter Ended June 30, 2022 Financial Summary

Key Points: 
  • First Quarter Ended June 30, 2022 Financial Summary
    As of June 30, 2022, we had cash, cash equivalents and restricted cash of approximately $2.0 billion.
  • Net loss was $353.8 million for the three months ended June 30, 2022 compared to $101.1 million for the three months ended June 30, 2021.
  • On a per common share basis, net loss was $0.48 for the three months ended June 30, 2022 and $0.13 for the three months ended June 30, 2021.
  • Non-GAAP net loss was $210.7 million for the three months ended June 30, 2022 compared to $133.4 million for the three months ended June 30, 2021.

Roivant Sciences Reports Financial Results for the Quarter Ended September 30, 2021 and Provides Business Update

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星期一, 十一月 15, 2021
Society, Gene, Safety, Achievement, PIPE, G&A, Quarter, Sarcoidosis, Novartis, Roivant Sciences, R, MAAC, ASH, Cincinnati Children's Hospital Medical Center, GM1, Growth, Calendar, Ciox Health, NEW, Graves' ophthalmopathy, Psoriasis, IND Culver Line, Namilumab, Sale, American Society of Hematology, SK, Acquisition, Research, GLOBE, Sickle cell disease, PGA, Business development, Program, Subclinical infection, Nasdaq, Patient, FDA, Atopic dermatitis, Bank, Pharmaceutical industry, Fine chemical

Roivant: Roivant closed its business combination with Montes Archimedes Acquisition Corp. (MAAC) and concurrent PIPE financing, and Roivant began trading on Nasdaq under the ticker ROIV.

Key Points: 
  • Roivant: Roivant closed its business combination with Montes Archimedes Acquisition Corp. (MAAC) and concurrent PIPE financing, and Roivant began trading on Nasdaq under the ticker ROIV.
  • Fiscal Quarter Ended September 30, 2021 Financial Summary
    As of September 30, 2021, we had cash and cash equivalents of approximately $2.5 billion.
  • Net loss for the three months ended September 30, 2021 was $225.6 million compared to $53.5 million for three months ended September 30, 2020.
  • Non-GAAP net loss was $169.2 million for the three months ended September 30, 2021 compared to $96.9 million for the three months ended September 30, 2020.

Humanigen Submits All Planned Modules for Potential Conditional Marketing Authorization from the UK’s MHRA

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星期五, 十月 1, 2021
Practice Management, Health, General Health, Pharmaceutical, Marketing, Communications, Research, Infectious Diseases, Hospitals, Science, Clinical Trials, MHRA, Mortality, IMV, Ventilation, Chemokine, Goal, COVID-19, Dexamethasone, Steroid, Medical Research Council, Review, MedRxiv, Medicines and Healthcare products Regulatory Agency, Risk, Șaeș, Granulocyte-macrophage colony-stimulating factor, Social work, Patient, CMA, Graft-versus-host disease, LinkedIn, Disease, Hellfire (J. T. Slade), Government, Twitter, Medical Research Council (United Kingdom), Death, CEO, Knowledge, Infliximab, Risk management, GM, Pneumonia, Kaplan–Meier estimator, GM-CSF, Severe cutaneous adverse reactions, Judgement, Conditional, Oxygen saturation (medicine), Department, Survival, Forward-looking statement, United, Namilumab, Nasdaq, SEC, Rheumatoid arthritis, Pharmaceutical industry, Medical device

We are pleased with the engagement with MHRA and are committed to continue to work with the agency as necessary to enable MHRA to review our application.

Key Points: 
  • We are pleased with the engagement with MHRA and are committed to continue to work with the agency as necessary to enable MHRA to review our application.
  • Thus, we are seeking Conditional Marketing Authorization with a view to bringing lenzilumab to patients in the UK.
  • The LIVE-AIR study achieved its primary endpoint of SWOV measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.0403).
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.

Humanigen Appoints Senior Executives to Management Team

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星期二, 七月 7, 2020
Research, FDA, Clinical trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Monoclonal antibodies, Medical specialties, Cytokines, Branches of biology, Medicine, Immunology, Lenzilumab, Granulocyte-macrophage colony-stimulating factor, Cytokine, Colony-stimulating factor, Interleukins, Namilumab

Humanigen, Inc. , (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating cytokine release syndrome (CRS) with lenzilumab, the companys proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, announced that several executives have been appointed to key positions at Humanigen.

Key Points: 
  • Humanigen, Inc. , (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating cytokine release syndrome (CRS) with lenzilumab, the companys proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, announced that several executives have been appointed to key positions at Humanigen.
  • All three positions report to Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen.
  • He is also the founder of Black Horse Capital with decades of biotechnology investment experience.
  • We are pleased that both Dr. Chappell and Mr. Tousley, who have previously operated in interim capacities with the Company, have joined us as full-time members of the Humanigen team, stated Dr. Cameron Durrant.

Granulocyte Macrophage Colony Stimulating Factor, Pipeline Review, H2 2019 - Amgen Inc, Seagull Labs Pvt Ltd & Cold Genesys Inc - ResearchAndMarkets.com

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星期一, 一月 20, 2020
Health, Pharmaceutical, Branches of biology, Cytokines, Growth factors, Granulocyte-macrophage colony-stimulating factor, Colony-stimulating factor, Immune system, Monoclonal antibodies, Sargramostim, Macrophage colony-stimulating factor, Macrophage, Lenzilumab, Namilumab

The "Granulocyte Macrophage Colony Stimulating Factor - Pipeline Review, H2 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Granulocyte Macrophage Colony Stimulating Factor - Pipeline Review, H2 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • According to the recently published report 'Granulocyte Macrophage Colony Stimulating Factor - Pipeline Review, H2 2019'; Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) pipeline Target constitutes close to 25 molecules.
  • Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a glycoprotein secreted by macrophages, T cells, mast cells, NK cells, endothelial cells and fibroblasts.
  • The report 'Granulocyte Macrophage Colony Stimulating Factor - Pipeline Review, H2 2019' outlays comprehensive information on the Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type; that are being developed by Companies / Universities.

Can-Fite BioPharma to Hold Investor Webinar and Q&A Session with CEO on November 25, 2019

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星期四, 十一月 21, 2019
Finance, FDA, Diabetes, Clinical trials, Professional services, Biotechnology, Health, Pharmaceutical, Oncology, RTT, Medical specialties, Medicine, Organ systems, Psoriasis, Arthritis, Prostate cancer, Namilumab, Amgen

A live Q&A session with Dr. Fishman will follow her presentation.

Key Points: 
  • A live Q&A session with Dr. Fishman will follow her presentation.
  • The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis.
  • Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.
  • These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date.