CIDP

Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q1 Financial Results

Retrieved on: 
Jeudi, mai 9, 2024
Janus, American Academy, Magic, Myasthenia gravis, Investment, Acetylcholine, Research, PIPE, Dianthus, Form, YTE, Therapy, Patient, Chemistry, CMC, AAN, Information, Multifocal motor neuropathy, Expense, G&A, CIDP, Clinical trial, Annual general meeting, GMG, Complement component 1s, MMN, Pharmaceutical industry

NEW YORK and WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the first quarter ending March 31, 2024, and provided an update on recent business achievements.

Key Points: 
  • “The first quarter of 2024 was highlighted by the initiation of our Phase 2 MaGic trial of DNTH103 for patients with gMG.
  • Initial top-line results from this trial are anticipated to be available in the second half of 2025.
  • Dianthus successfully completed a private investment in public equity (“PIPE”) financing in January 2024 that resulted in gross proceeds of approximately $230 million.
  • Additional Information - For additional information on the Company’s financial results for the quarter ended March 31, 2024, please refer to the Form 10-Q filed with the SEC.

argenx Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Jeudi, mai 9, 2024
MuSK protein, FDA, ARDA, IND, PDUFA, Medicine, Autoimmunity, Efgartigimod alfa, Glomerulonephritis, CMS, Inflammation, ITP, IIP, ALS, Alfa Romeo, C2, Therapy, Systemic scleroderma, Safety, Euronext, Nektar, DGF, Sjögren syndrome, CIDP, Biology, IL-6, Nektar Therapeutics, GMG, TED, File, MMN, Lupus nephritis, Kidney, AMR, Multifocal motor neuropathy, Patient, Congenital myasthenic syndrome, Immune system, Dermatomyositis, Growth, Amgen, Pharmaceutical industry

“The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • “We are driven by our commitment to provide patients with the broadest gMG product offering that consistently delivers on safety and efficacy.
  • VYVGART SC played a key role in our growth over the quarter, expanding the breadth of our prescriber base and reaching new patients.
  • In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).

Hawaii Specialty Pharmacy Announces New Ambulatory Infusion Centers to Serve Maui Community, Invites Local Media and Community Members to Opening Reception

Retrieved on: 
Mercredi, mai 8, 2024
Physician, Ulcerative colitis, Makawao, Hawaii, Patient, Cancer, Pharmacy, Hospital, Health, Heart, Chronic inflammatory demyelinating polyneuropathy, Nursing, Doctor of Pharmacy, Rheumatoid arthritis, HSP, Multiple sclerosis, CIDP

MAKAWAO, Hawaii, May 8, 2024 /PRNewswire/ -- Hawaii Specialty Pharmacy (HSP), a leading provider of specialty infusion pharmacy services with a focus on high-touch patient care and a mission to optimize patient health, today announced the opening of two new ambulatory infusion centers in Maui, Hawaii.

Key Points: 
  • MAKAWAO, Hawaii, May 8, 2024 /PRNewswire/ -- Hawaii Specialty Pharmacy (HSP), a leading provider of specialty infusion pharmacy services with a focus on high-touch patient care and a mission to optimize patient health, today announced the opening of two new ambulatory infusion centers in Maui, Hawaii.
  • "Empowering our community with comprehensive healthcare solutions has always been at the heart of Hawaii Specialty Pharmacy's mission," says George Kridner, PharmD, CEO of Hawaii Specialty Pharmacy.
  • Since its inception in 2018, Hawaii Specialty Pharmacy has distinguished itself by offering a local and personalized approach to patients managing complex and rare conditions.
  • Maui is excited to welcome these new infusion centers and their staff into the heart of our community."

argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease

Retrieved on: 
Mardi, avril 16, 2024
Autoantibody, FDA, American Academy, Immunoglobulin G, University, Clinical trial, Priority review, Risk, Safety, Food, ECI, Chronic inflammatory demyelinating polyneuropathy, Euronext, Research, Disease, PDUFA, Patient, Principal, AAN, CIDP, Biology, University of Minnesota, GMG, Autoimmunity, Pharmaceutical industry

“Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx.

Key Points: 
  • “Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx.
  • “The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden.
  • VYVGART Hytrulo was well-tolerated, and the observed safety and tolerability profile was consistent with previous clinical trials.
  • Clinical trial data and real-world evidence presented during AAN continue to highlight the differentiated efficacy and safety profile of VYVGART and VYVGART Hytrulo, driving rapid, deep, and sustained improvement across disease scales and with different dosing schedules, including the ability for patients to achieve minimal symptom expression (MSE).

Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q4 and FY2023 Financial Results

Retrieved on: 
Jeudi, mars 21, 2024
Janus, Research, MMN, Myasthenia gravis, Dianthus, GMG, CIDP, Half-life, Form, Patient, Complement component 1s, Magenta, Acetylcholine, American Academy, CMC, G&A, YTE, Drug, AAN, Investment, Therapy, PIPE, Magic, Multifocal motor neuropathy, Annual general meeting, Pharmaceutical industry

NEW YORK and WALTHAM, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the fourth quarter and full year ending December 31, 2023, and provided an update on recent business achievements.

Key Points: 
  • DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need.
  • Initial top-line results from this trial are anticipated to be available in the second half of 2025.
  • Dianthus successfully completed a private investment in public equity (“PIPE”) financing in January 2024 that resulted in gross proceeds of approximately $230 million.
  • Additional Information – For additional information on the Company’s financial results for the year ended December 31, 2023, please refer to the Form 10-K filed with the SEC.

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Mercredi, mars 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting

Retrieved on: 
Jeudi, mars 7, 2024
OCS, Neonatal Fc receptor, Autoimmune disease, Continuity, ADAPT, CIDP, Alfa Romeo, FDA, Immunoglobulin therapy, Quality of life, NXT, PDUFA, Euronext, Risk, AAN, Clinical trial, Immunoglobulin G, GMG, Abstract, Efficacy, American Academy, Pharmaceutical industry

“We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.

Key Points: 
  • “We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
  • Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies.
  • Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment.

argenx Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update

Retrieved on: 
Jeudi, février 29, 2024
DGF, Neonatal Fc receptor, ALS, Congenital myasthenic syndrome, CMS, CIDP, MMN, Alfa Romeo, IIP, IL-6, FDA, Inflammation, MHLW, PDUFA, Euronext, Neurology, MuSK protein, Kidney, ARDA, Health care, C2, GMG, Ministry of Health, Dermatomyositis, Patient, Efgartigimod alfa, MHRA, Medicine, Multifocal motor neuropathy, Immune system, Pharmaceutical industry

“argenx reached thousands of new patients and their families in 2023 by delivering on our commitment to make VYVGART available to the global MG community,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx reached thousands of new patients and their families in 2023 by delivering on our commitment to make VYVGART available to the global MG community,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • Clinically, we generated significant data through multiple study readouts, achieving key milestones for both the CIDP and MMN patient communities and importantly advancing our second molecule, empasiprubart.
  • Looking forward to 2024, we will act with a continued sense of purpose to expand our patient reach.
  • In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
Mardi, février 20, 2024
Neonatal Fc receptor, Chronic inflammatory demyelinating polyneuropathy, Autoimmune disease, CIDP, FDA, Food, ECI, PDUFA, Euronext, Risk, Autoantibody, Safety, Immunoglobulin G, Patient, Clinical trial, Biology, Pharmaceutical industry

“Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.

Key Points: 
  • “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.
  • We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options.
  • In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.
  • VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®.

Zai Lab Announces Full-Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Mardi, février 27, 2024
Oncology, Mental Health, Health, Infectious Diseases, Neurology, Pharmaceutical, Biotechnology, NSCLC, TED, Blood pressure, Cervical cancer, Psoriasis, Cetuximab, Infection, New Drug Application, SCLC, MAA, National Medical Products Administration, PMA, CIDP, NTRK, FDA, Nivolumab, Food, GEJ, Shanda, Schizophrenia, PDUFA, CRC, Bristol Myers Squibb, BMS, ADP, Safety, Mirati, TPS, Disease, HKT, Patient, Clinical trial, METIS, Fusion, Pancreatic cancer, NDA, NMPA, Pharmaceutical industry

The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.

Key Points: 
  • The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.
  • Zai Lab has joined the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or GEJ cancer in Greater China.
  • Zai Lab to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024.
  • Zai Lab to complete patient enrollment in the China bridging study in schizophrenia in the fourth quarter of 2024.