Pemphigus

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

Retrieved on: 
Thursday, March 21, 2024
Research, MPV, IIM, MuSK protein, Toxicity, Conference, Disease, Dermatomyositis, Juvenile dermatomyositis, Federation, Patient, NOL, Observation, CRS, SLE, Health Canada, IND, Immunoglobulin therapy, Pemphigus, Investment, Investigational New Drug, Myopathy, Systemic scleroderma, Marketing, FDA, Clinical trial, Cytokine release syndrome, Cyclophosphamide, CD19, Food, Autoimmune disease, Pharmaceutical industry

In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.

Key Points: 
  • In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.
  • In November 2023, Cabaletta announced that its IND application for CABA-201 was allowed to proceed by the FDA for the Phase 1/2 RESET-MG trial.
  • Cabaletta anticipates reporting initial clinical data from the Phase 1/2 RESET-MG trial in the second half of 2024.
  • As of December 31, 2023, Cabaletta had cash, cash equivalents and short-term investments of $241.2 million, compared to $106.5 million as of December 31, 2022.

Human medicines European public assessment report (EPAR): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Risk, MPA, Shivering, CD20, PML, ACR20, Pemphigus vulgaris, Cancer, Inflammation, Death, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Pemphigus, Allergy, B cell, Hepatitis B virus, Glucocorticoid, NHL, CLL, Safety, Rheumatoid arthritis, Arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Language, Blood, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, Autoimmune disease, TNF, CHOP, Vasculitis, European Medicines Agency, Doxorubicin, Cell, Chronic lymphocytic leukemia, Resuscitation, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, Pemphigus, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Bone marrow, GPA, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, November 28, 2023
Patient, IWG, Pemphigus, Data, Disease, Conference call, Euronext, Neonatal Fc receptor, ITP, Safety, Nursing

The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients.

Key Points: 
  • The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients.
  • Additional analyses of the dataset are ongoing and the full results will be presented at an upcoming medical meeting and in a peer-reviewed publication.
  • “We are very grateful to everyone involved in the ADVANCE-SC study, especially the patients and their families, the investigators, and our internal team who worked tirelessly to complete this global study.
  • A webcast of the live call and replay may be accessed on the Investors section of the argenx website.

Cabaletta Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 9, 2023
SLE, GMG, FDA, Systemic scleroderma, Research, CAR, CART, Report, American College, IND, Syndrome, Cyclophosphamide, MPV, MuSK protein, Dermatomyositis, Food, Nidec ASI, Myositis, Oxford, CD19, Molecular Therapy, Pemphigus, Good manufacturing practice, MG, Lupus, Conference, University, DM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Maintenance, American College of Rheumatology, Development, Wuxi, San Diego Convention Center, Disease, Scleroderma, Immunoglobulin therapy, GMP, Autoimmunity, Investment, Patient, ACR, Investigational New Drug, Pharmaceutical industry, Vaccine, Nightclub, Cryptocurrency, Cabaletta, Limited

PHILADELPHIA, Nov. 09, 2023 (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 reported financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • In November 2023, Cabaletta announced the Company’s fourth IND application for CABA-201 was cleared by the FDA for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG).
  • Cabaletta will present new preclinical data for CABA-201 in a poster presentation and Cabaletta Bio Scientific Advisory Board members Carl June, M.D., and Georg Schett, M.D.
  • Cabaletta plans to participate in the following upcoming investor conferences:
    Stifel 2023 Healthcare Conference, which is being held from November 14-15, 2023 in New York, NY.
  • As of September 30, 2023, Cabaletta had cash, cash equivalents and short-term investments of $164.4 million, compared to $106.5 million as of December 31, 2022.

Cabaletta Bio Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023
Exercise, Science, Gilead Sciences, Lupus, Maintenance, CD19, DM, MuSK protein, Gene, Compensation, Non-Hodgkin lymphoma, Immunoglobulin therapy, Clinical trial, Cyclophosphamide, Dermatomyositis, SLE, Syndrome, Pemphigus, Asis Datta, LN, Parliamentary Information Technology Committee, Myositis, Citigroup, Investigational New Drug, MG, Patient, Investment, Annual general meeting, Cell, American Society of Gene and Cell Therapy, Kite Pharma, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Society, Conference, Food, MPV, Disease, Pharmaceutical industry, Vaccine, Cryptocurrency, Cabaletta

PHILADELPHIA, Aug. 10, 2023 (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 reported financial results for the second quarter ended June 30, 2023, and provided a business update.

Key Points: 
  • PHILADELPHIA, Aug. 10, 2023 (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 reported financial results for the second quarter ended June 30, 2023, and provided a business update.
  • Cabaletta anticipates generating 3-month clinical data on efficacy and tolerability in initial CABA-201 treated patients by the first half of 2024.
  • 2023 Cantor Global Healthcare Conference, which is being held from September 26-28, 2023 in New York, NY.
  • As of June 30, 2023, Cabaletta had cash, cash equivalents and short-term investments of $176.3 million, compared to $106.5 million as of December 31, 2022.

Collaborators at the Keio and Osaka Universities Present Key Non-Clinical Data with Stable/Functional-Induced Regulatory T Cells (S/F-iTregs) in Autoimmune Disease Models

Retrieved on: 
Monday, May 29, 2023
Osaka University, Kyoto, Patient, Keio University, Kyoto University, ISID, Immunoglobulin G, Vaccine, Regulatory T cell, Pemphigus

OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.

Key Points: 
  • OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.
  • Their presentation demonstrated that in a murine pemphigus model, S/F-iTregs significantly decreased clinical scores, circulating anti-Dsg3 IgG titers, and other autoimmune markers related to Pemphigus.
  • Collaborators also reported that S/F-iTregs generated from samples obtained from patients with Pemphigus also showed potent inhibition of autologous T cell proliferation in vitro.
  • Tregs play a central role in managing immune self-tolerance and depleted or dysfunctional Tregs are characteristic of many autoimmune disorders.

Collaborators at the Keio and Osaka Universities Present Key Non-Clinical Data with Stable/Functional-Induced Regulatory T Cells (S/F-iTregs) in Autoimmune Disease Models

Retrieved on: 
Monday, May 29, 2023
Osaka University, Kyoto, Patient, Keio University, Kyoto University, ISID, Immunoglobulin G, Vaccine, Regulatory T cell, Pemphigus

OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.

Key Points: 
  • OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.
  • Their presentation demonstrated that in a murine pemphigus model, S/F-iTregs significantly decreased clinical scores, circulating anti-Dsg3 IgG titers, and other autoimmune markers related to Pemphigus.
  • Collaborators also reported that S/F-iTregs generated from samples obtained from patients with Pemphigus also showed potent inhibition of autologous T cell proliferation in vitro.
  • Tregs play a central role in managing immune self-tolerance and depleted or dysfunctional Tregs are characteristic of many autoimmune disorders.

AMERICAN SKIN ASSOCIATION ANNOUNCES 2023 RESEARCH ACHIEVEMENT AWARDS

Retrieved on: 
Wednesday, May 17, 2023
ASA, AWARD, Oregon Health and Science University Center for Women's Health, ISID, Skin cancer, Public policy, Atopic dermatitis, Research, Keio University, Inflammation, Doctor of Philosophy, Autoimmunity, Homeostasis, Peripheral tolerance, Psoriasis, Oregon Health & Science University, Professor, Pemphigus, International Society for Bipolar Disorders, Melanoma, Allergy, GEORGE, Ponce Health Sciences University, Vitiligo, Skin, Medical device, Dermatology, MD

NEW YORK, May 17, 2023 /PRNewswire/ -- American Skin Association (ASA) announced the recipients of the 2023 David Martin Carter Mentor Award, 2023 George W. Hambrick Award, and the 2023 Research Achievement Awards at the International Societies for Investigative Dermatology (ISID) in Tokyo, Japan.

Key Points: 
  • MASAYUKI AMAGAI, MD, PhD 2023 RECIPIENT OF GEORGE W. HAMBRICK AWARD
    NEW YORK, May 17, 2023 /PRNewswire/ -- American Skin Association (ASA) announced the recipients of the 2023 David Martin Carter Mentor Award, 2023 George W. Hambrick Award, and the 2023 Research Achievement Awards at the International Societies for Investigative Dermatology (ISID) in Tokyo, Japan.
  • "ASA is honored to recognize Dr. Hanifin and Dr. Amagai and all the 2023 Research Achievement Award recipients for their tireless efforts in the field of dermatology.
  • Dr. Amagai's clinical and research interests center on autoimmune and allergic skin diseases, skin barrier, and skin immunology.
  • ASA's Research Achievement Awards were instituted in 1989 to help identify established scientists in investigative dermatology and cutaneous biology.

NexImmune Reports First Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Monday, May 15, 2023
Sclerosis, AIM, Infection, Stroke, GAAP, Multiple sclerosis, Immunotherapy, Bangladesh Technical Education Board, ASCO, National Institute of Neurological Disorders and Stroke, DSM-IV codes, Pemphigus, Transplant, NEXI, BCMA, Vitiligo, Research, Autoimmunity, Vaccine, Pharmaceutical industry

“This is an exciting time for NexImmune, as we remain focused on progressing the development of novel approaches in the field of immunotherapy,” said Kristi Jones, NexImmune’s CEO.

Key Points: 
  • “This is an exciting time for NexImmune, as we remain focused on progressing the development of novel approaches in the field of immunotherapy,” said Kristi Jones, NexImmune’s CEO.
  • “Interest in antigen specific approaches for oncology, autoimmune disorders and infectious diseases has never been higher.
  • Based upon current operating plans, NexImmune expects that its existing cash and cash equivalents will enable the Company to fund its operating and capital expenditure requirements into the fourth quarter of 2023.
  • Research and development expenses were $6.1 million in the first quarter of 2023, compared to $10.4 million for the same period in the prior year.