Myositis

IGM Biosciences Announces First Quarter 2024 Financial Results and Provides Corporate Update

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星期三, 五月 8, 2024
PFS, Myopathy, Patient, Research and development, Investment, Colorectal cancer, Progression-free survival, Research, Immunoglobulin M, CD38, Bevacizumab, Trial of the century, Lupus, Administration, Rheumatoid arthritis, IGM, Myositis, SLE, Clinical trial, FOLFIRI, Rheumatism, GAAP, G&A

MOUNTAIN VIEW, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fiscal quarter ended March 31, 2024 and provided an update on recent developments.

Key Points: 
  • MOUNTAIN VIEW, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fiscal quarter ended March 31, 2024 and provided an update on recent developments.
  • Collaboration Revenue: For the first quarter of 2024 and 2023, collaboration revenues were $0.5 million in each quarter.
  • Research and Development (R&D) Expenses: For the first quarter of 2024, R&D expenses were $43.8 million, compared to $50.9 million for the first quarter of 2023.
  • General and Administrative (G&A) Expenses: For the first quarter of 2024, G&A expenses were $10.5 million, compared to $13.0 million for the first quarter of 2023.

Early Pulmonary Fibrosis Detection Holds the Key to Better Health Outcomes for Canadians Living with COVID-19 and Rheumatoid Arthritis

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星期三, 二月 28, 2024
Rare disease, Oxygen, Connective tissue disease, Research, Scleroderma, Physician, St. Joseph's Health Centre, Lupus, Crackle, Myositis, Pulmonary fibrosis, Life, CPFF, COVID-19, Signs, Rheumatoid arthritis, COVID, Patient, Disease, Diagnosis, Connective tissue, Interview, Face, Pharmaceutical industry

Canadians who have had COVID-19, and other chronic diseases, are experiencing Pulmonary Fibrosis (PF) at significantly higher rates than others, seemingly providing a causal link that researchers are investigating.

Key Points: 
  • Research is shedding light on the growing rate of pulmonary fibrosis (PF) being found in people suffering from long-term COVID-19.
  • One study, Post COVID-19 pulmonary fibrosis; a meta-analysis study , found that almost 45% (44.9%) of study participants began suffering from PF after contracting COVID-19.
  • Canadians suffering from long COVID are encouraged to watch for the early signs of pulmonary fibrosis, a disease that is growing in this population.
  • Dr. Janet Pope's webinar includes explanations for both physicians and thousands of people living with connective tissue diseases of what pulmonary fibrosis symptoms to watch for.

IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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星期四, 三月 7, 2024
CD20, Progression-free survival, PFS, Myopathy, Research, Immunoglobulin M, Investment, FDA, Research and development, IGM, FOLFIRI, Myositis, Bevacizumab, Lupus, GAAP, Rheumatoid arthritis, Administration, Patient, Clinical trial, Survival, CD38, SLE, G&A, IND, Colorectal cancer, Pharmaceutical industry

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.

Key Points: 
  • MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.
  • Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively.
  • Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively.
  • General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively.

Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis

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星期四, 二月 1, 2024
Clinical trial, Patient, Food, Myositis, ODD, Myopathy, IIM, Immune system, FDA, Marketing, Pharmaceutical industry

CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells.

Key Points: 
  • CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells.
  • Four RESET™ (REstoring SElf-Tolerance) Phase 1/2 trials are advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-Myositis™ trial.
  • “Myositis, believed to be driven by B cells, is a severe and potentially fatal autoimmune disease for which no curative therapy exists.
  • This designation qualifies Cabaletta for certain incentives, which may include partial tax credit for clinical trial expenditures, waived user fees and potential eligibility for seven years of marketing exclusivity.

Cabaletta Bio Receives Additional FDA Fast Track Designations for CABA-201 in Dermatomyositis and Systemic Sclerosis

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星期一, 一月 8, 2024
Dermatomyositis, Food, GMG, IND, Research, FDA, SLE, Organ dysfunction, Scleroderma, Investigational New Drug, Systemic scleroderma, Myositis, Patient, Lupus nephritis, Pharmaceutical industry

PHILADELPHIA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted separate Fast Track Designations to CABA-201, an investigational 4-1BB-containing fully human CD19-CAR T cell therapy, for the treatment of patients with dermatomyositis to improve disease activity and for the treatment of patients with systemic sclerosis (SSc) to improve associated organ dysfunction.

Key Points: 
  • “The additional Fast Track Designations for CABA-201 in both dermatomyositis and systemic sclerosis, the second and third Fast Track Designations for CABA-201, provide the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune indications where there is a significant unmet need, despite currently available therapies,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta.
  • “We believe these designations potentially accelerate our ability to launch the first targeted, and potentially curative, cell therapy for autoimmune diseases driven by B cells.
  • To date, Cabaletta has received clearance from the FDA for Investigational New Drug (IND) applications for CABA-201 in multiple autoimmune conditions including systemic lupus erythematosus (SLE), myositis, SSc and generalized myasthenia gravis (gMG).
  • Cabaletta is conducting four Phase 1/2 clinical trials with a total of nine cohorts that can advance simultaneously, employing a similar parallel cohort design and starting dose of 1 x 106 cells/kg without a dose escalation requirement.

Zura Bio Continues to Strengthen Leadership with Appointment of Robert Lisicki as President and Kiran Nistala as CMO

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星期一, 一月 8, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Marketing, Arena, Pfizer, Autoimmune disease, GSK plc, Dermatology, Multimedia, Johnson & Johnson, Amgen, AstraZeneca, Child, Rheumatology, Arena Pharmaceuticals, Protocol, Trust, Lupus, CCO, University, Wellcome Trust, Doctor of Philosophy, Therapy, Senior, State, University College London, Great Ormond Street Hospital, Inflammation, Myositis, MBBS, Regeneron Pharmaceuticals, Growth, Mergers and acquisitions, Patient, State university system, Economics, Scleroderma, Management

Mr. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company.

Key Points: 
  • Mr. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company.
  • Mr. Lisicki and Dr. Nistala have successfully worked on or led in the development of multiple drugs within the auto-immune therapeutic area.
  • These executives position Zura Bio to deliver on the promise of their innovative medicines for patients in need of better clinical outcomes.
  • View the full release here: https://www.businesswire.com/news/home/20240108851979/en/
    “I am very pleased to welcome Rob and Kiran to Zura Bio as members of the Executive Team.

Adicet Provides Corporate Update and Highlights Strategic Priorities for 2024

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星期四, 一月 4, 2024
Oncology, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Telephone, Initiate, Myositis, Tumor microenvironment, Risk, Probability, IND, Autoimmunity, FDA, Cytokine release syndrome, CD20, Renal cell carcinoma, Scleroderma, Tissue, Cmax, Cancer, TGF, Tropism, NHL, Patient, CD19, AUC, Safety, Lupus nephritis, CD70, MCL, Pharmaceutical industry

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, today provided corporate updates and highlighted upcoming priorities for its pipeline programs in 2024.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, today provided corporate updates and highlighted upcoming priorities for its pipeline programs in 2024.
  • “In 2024, we aim to make significant strides across our pipeline of differentiated gamma delta T cell therapies through our strategic and disciplined approach,” said Chen Schor, President and Chief Executive Officer at Adicet Bio.
  • Initiate Phase 1 clinical trial of ADI-001 for the treatment of lupus nephritis in the second quarter of 2024.
  • The Company remains on track to provide an ADI-001 clinical update in the second half of 2024.

IGM Biosciences Announces Strategic Pipeline Prioritization and Cash Runway Extension

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星期二, 十二月 5, 2023
Workforce, DR5, Sanofi, IND, Antibody, FDA, Colorectal cancer, FOLFIRI, CD20, SLE, IGM, Clinical trial, Rheumatoid arthritis, Inflammation, Investigational New Drug, Lupus, CD38, Bevacizumab, Myopathy, Myositis, Patient, Immunoglobulin M, Vaccine

In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.

Key Points: 
  • In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.
  • As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.
  • “IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • As a part of this strategic refocusing, the Company will halt the following clinical development activities:

IGM Biosciences Announces Third Quarter 2023 Financial Results

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星期一, 十一月 13, 2023
Myositis, CD38, Safety, Food, Treatment, Progression-free survival, Colorectal cancer, Acute myeloid leukemia, Myopathy, Bevacizumab, IND, Investment, Immunoglobulin G, Clinical trial, Net, Administration, Patient, Research, Lupus, Rheumatoid arthritis, FDA, Autoimmune disease, American College, G&A, Bispecific monoclonal antibody, FOLFIRI, SLE, Immunoglobulin M, GAAP, CD20, R, Antibody, Research and development, IGM, Azacitidine, Pharmaceutical industry, Vaccine, Sanofi

MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.
  • “During the third quarter, we continued to execute across our clinical development pipeline,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • Collaboration Revenue: For the third quarter of 2023, collaboration revenues were $0.5 million, compared to $0.3 million for the same period in 2022.
  • Research and Development (R&D) Expenses: For the third quarter of 2023, R&D expenses were $54.8 million, compared to $48.2 million for the same period in 2022.

TMA welcomes new executive director

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星期四, 十一月 16, 2023
Myositis, CAE, Tulane University, Research, Specialization, AMCP, TMA, Council, MBA, MD, Growth, Society, Rural housing, Volunteering, Management, Virginia Tech

COLUMBIA, Md., Nov. 16, 2023 /PRNewswire/ -- The Myositis Association (TMA) is excited to announce that Paula Eichenbrenner, MBA, CAE, has joined the organization as its new executive director, effective November 29, 2023.

Key Points: 
  • COLUMBIA, Md., Nov. 16, 2023 /PRNewswire/ -- The Myositis Association (TMA) is excited to announce that Paula Eichenbrenner, MBA, CAE, has joined the organization as its new executive director, effective November 29, 2023.
  • Eichenbrenner comes to TMA from the Academy of Managed Care Pharmacy (AMCP) Foundation, where she served as executive director since 2015.
  • "We are delighted to welcome Paula to TMA as our new executive director," said David Mochel, MD, chair of TMA's board of directors.
  • "I am honored and excited to join TMA as its new executive director," said Eichenbrenner.