Associated tags: FDA, Acetylcholine receptor, GMG, Alfa Romeo, Patient, IIP, Euronext, Pharmaceutical industry
Locations: CHINA, JAPAN, NORTH AMERICA, NEW YORK, LONDON, NY, UK, BOSTON, DENMARK, GERMANY, BREDA, NL, SC, UNITED KINGDOM, DM, MG, SWITZERLAND, SAUDI ARABIA, CANADA, EUROPE, AUSTRALIA, NETHERLANDS, TD, MA
Retrieved on:
Wednesday, March 27, 2024
Disease,
Patient,
Biomarker,
STAR,
Euronext,
Woman,
EULAR,
Safety,
Composite,
Immunoglobulin G,
RHO,
Serology “We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
Key Points:
- “We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
- “Consistent with our indication selection strategy, we confirmed our IgG biology hypothesis with these data, and now have a demonstrated clinical effect across multiple efficacy scales to support proof-of-concept.
- Sjogren’s disease can be debilitating, predominantly affects women, and given its heterogeneous nature, is often misdiagnosed with its symptoms poorly understood.
- Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data.
The shareholders and all other persons with meeting rights are invited to attend the Annual General Meeting of shareholders.
Key Points:
- The shareholders and all other persons with meeting rights are invited to attend the Annual General Meeting of shareholders.
- The company’s annual report for the financial year ended December 31, 2023 is now available on its website www.argenx.com/investors/financial-reports .
- The full agenda for the meeting as well as all ancillary documents relevant for the meeting are available via the argenx website and are also available for inspection at the argenx offices.
- argenx would like to encourage shareholders to use the voting by (electronic) proxy option as referred to in the convocation.
Diagnosis,
Blood pressure,
Efgartigimod alfa,
System,
Urination,
Urinary tract infection,
MHLW,
Chest pain,
Rituximab,
Allergy,
Disease,
Infection,
Risk,
Headache,
Patient,
Sore throat,
IWG,
History,
ITP,
Chills,
Quality of life,
Cough,
Euronext,
Rash,
Respiratory tract infection,
Splenectomy,
Medicine,
Skin,
Fever,
Antibody,
Wheeze,
Back pain,
Shivering,
Safety,
Pain,
Fatigue,
Phlegm,
Swelling,
Food,
Autoimmune disease,
Nursing “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
Key Points:
- “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
- By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
- ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
- Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.
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.
Retrieved on:
Thursday, February 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).
Retrieved on:
Monday, February 26, 2024
Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that members of the management team will participate in the following investor conferences in March:
Key Points:
- Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that members of the management team will participate in the following investor conferences in March:
TD Cowen 44th Annual Health Care Conference.
- Fireside chat on Monday, March 4, 2024 at 11:10 a.m.
- ET in Boston, MA.
Retrieved on:
Thursday, February 22, 2024
Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, February 29, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its full year 2023 financial results and provide a fourth quarter business update.
Key Points:
- Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, February 29, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its full year 2023 financial results and provide a fourth quarter business update.
- A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors .
- A replay of the webcast will be available on the argenx website for approximately one year following the presentation.
Retrieved on:
Tuesday, February 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®.
Retrieved on:
Thursday, January 18, 2024
Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.
Key Points:
- Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.
- “Today’s approval of VYVDURA marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, General Manager, argenx Japan.
- ADAPT-SC established the efficacy of VYVDURA by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART IV in adult gMG patients.
- ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART in Japan in January 2022.
Immunoglobulin therapy,
GMG,
FDA,
PRV,
Congenital myasthenic syndrome,
ARDA,
Research Councils UK,
Euronext,
Inflammation,
Cohort,
PGIC,
NRDL,
Autoimmunity,
Efgartigimod alfa,
Dermatomyositis,
Conference,
MuSK protein,
IND,
CIDP,
Pharmacokinetics,
MMN,
Safety,
Therapy,
Patient,
ALS,
Immune system,
IL-6,
Medicine,
International Myeloma Foundation,
IIP,
FSS,
Neonatal Fc receptor,
Multifocal motor neuropathy,
Growth,
Pharmaceutical industry argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.
Key Points:
- argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.
- In addition, ARGX-119, a muscle-specific kinase (MuSK) agonist, will initiate Phase 1b/2a studies in congenital myasthenic syndrome and amyotrophic lateral sclerosis in 2024.
- As of December 31, 2023, argenx had approximately $3.2 billion in cash, cash equivalents and current financial assets*.
- Based on its current operating plans, argenx expects its combined R&D and SG&A expenses in 2024 to be less than $2 billion.
