GMG

argenx Announces European Commission Approval of Subcutaneous VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis

Retrieved on: 
Thursday, November 16, 2023
Acetylcholine receptor, European Commission, GMG, Civil service commission, Patient, Autoimmune disease, CHMP, Committee, Efgartigimod alfa, Euronext, SE

Following this decision, VYVGART is now approved in Europe for both IV and self-administered SC use.

Key Points: 
  • Following this decision, VYVGART is now approved in Europe for both IV and self-administered SC use.
  • The approval is applicable to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein.
  • argenx will work with local health authorities to secure patient access for VYVGART SC in the region.
  • We are proud to deliver this second formulation to the European gMG community, just 15 months after the initial approval of VYVGART IV,” said Anant Murthy, General Manager of argenx EMEA.

Dianthus Therapeutics Highlights Recent Business Achievements and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
MMN, Muscle contraction, Therapy, Multifocal motor neuropathy, Investment, Disease, Risk, Form, Magenta, GMG, Patient, Complement component 1s, Research, CIDP, Bacteria, Half-life, Infection, Dianthus, YTE, Vaccine, Pharmaceutical industry, Airline, Cryptocurrency

Top-line Phase 1 data across seven single and multiple ascending dose cohorts with 52 healthy volunteers establish DNTH103’s best-in-class potential.

Key Points: 
  • Top-line Phase 1 data across seven single and multiple ascending dose cohorts with 52 healthy volunteers establish DNTH103’s best-in-class potential.
  • Research and development expenses for the quarter ended September 30, 2023 were $8.0 million, inclusive of $0.4 million of stock-based compensation.
  • Net loss for the quarter ended September 30, 2023 was $14.8 million or $3.78 net loss per share (basic and diluted).
  • For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

Zai Lab Announces the First Listing of VYVGART® (efgartigimod alfa injection) and Other Updates in China’s National Reimbursement Drug List

Retrieved on: 
Wednesday, December 13, 2023
Neurology, Biotechnology, Pharmaceutical, Managed Care, Oncology, Health, Infectious Diseases, Health Insurance, Acetylcholine receptor, HKEX, GMG, Patient, Zai, Ovarian cancer, Niraparib, NRDL, Pharmaceutical industry

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:

Key Points: 
  • Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:
    VYVGART® (efgartigimod alfa injection) is included for the first time in the NRDL for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive;
    ZEJULA® (niraparib) is renewed for the maintenance treatment of adult patients with platinum-sensitive, first-line and recurrent ovarian cancer.
  • “The initial NRDL inclusion for VYVGART is an especially important milestone for gMG patients and underscores the clinical value Zai Lab is delivering to the medical community and to patients in China,” said William Liang, Chief Commercial Officer of Zai Lab.
  • “We are pleased that we now have four products included in the NRDL, and we will continue our efforts to expand patient access to our innovative treatments, including through NRDL coverage of different indications and formulations for our commercial products.
  • We are grateful for this action by the NHSA, and we look forward to continuing to work with the NHSA to improve patient access and costs for high-quality treatments in China.”

Gabriel Marketing Group Launches New Website with All-new Design and Packaging of Its Strategic Communications Services

Retrieved on: 
Thursday, November 30, 2023
Marketing, Social media, PR, GMG

MCLEAN, Va., Nov. 30, 2023 /PRNewswire-PRWeb/ -- Gabriel Marketing Group (GMG), the industry's leading public relations and marketing agency for high-growth, mission-driven organizations, today launched its new website featuring an all-new design and and all-new packaging of its market strategy, public relations, analyst relations, social media and content development services.

Key Points: 
  • GMG's new website aligns its market strategy, public relations, analyst relations, social media and content development services with its mission of uniting changemakers with dynamic opportunities to challenge the status quo.
  • MCLEAN, Va., Nov. 30, 2023 /PRNewswire-PRWeb/ -- Gabriel Marketing Group (GMG), the industry's leading public relations and marketing agency for high-growth, mission-driven organizations, today launched its new website featuring an all-new design and and all-new packaging of its market strategy, public relations, analyst relations, social media and content development services.
  • In redesigning its website and how it presents its services, GMG applied its own successful, proprietary methodology for defining and clarifying brands.
  • The new website features a user experience enriched with carefully selected imagery, bright colors and compelling messaging, creating a powerful tool for communicating GMG's value proposition.

Halozyme Announces argenx Receives European Commission Approval of VYVGART® SC with ENHANZE® for Generalized Myasthenia Gravis

Retrieved on: 
Thursday, November 16, 2023
Acetylcholine receptor, Food, European Commission, Immunoglobulin G, GMG, Patient, CHMP, Committee, Efgartigimod alfa, Pharmaceutical industry, Vaccine, Halozyme

SAN DIEGO, Nov. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received European Commission (EC) approval of VYVGART® SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The European approval of VYVGART SC provides the option for patient self-administration. The EC approval is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein.

Key Points: 
  • The European approval of VYVGART SC provides the option for patient self-administration.
  • The EC approval is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein.
  • VYVGART® SC was approved by the U.S. Food and Drug Administration in June 2023 and is marketed as VYVGART® Hytrulo.
  • ADAPT-SC established the efficacy of VYVGART® SC by demonstrating a reduction in anti-AChR antibody levels comparable to VYVGART® IV in adult gMG patients.

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 Receives FDA Clearance of CABA-201 IND Application for Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Monday, November 6, 2023
GMG, Steroid, FDA, IND, Respiratory failure, Food, Enzyme inhibitor, Myositis, MG, Lupus, Autoantibody, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Protein, Disease, Clinical trial, Acetylcholine receptor, Risk, Neurology, Neuromuscular junction, Autoimmune disease, Scleroderma, NMJ, Patient, Investigational New Drug, Rheumatology, Fatigue, Pharmaceutical industry

PHILADELPHIA, Nov. 06, 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 announced that the Company’s fourth Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel gMG cohorts based on autoantibody status – one cohort of six patients with acetylcholine receptor (AChR) antibody-positive gMG and a second cohort of six patients with AChR antibody-negative gMG. Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.

Key Points: 
  • Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.
  • The announcement of our fourth CABA-201 IND clearance is also our first IND clearance for the product candidate in a predominantly autoantibody mediated disease.
  • Generalized MG affects approximately 85% of the between 50,000 and 80,000 estimated MG patients in the United States.
  • Standard of care therapies include cholinesterase inhibitors, steroids, immunomodulators, and biologics, which often provide modest clinical effect and require chronic administration, increasing the risk of serious long-term side effects.

BioCryst R&D Day Highlights New Diversified Pipeline of First-in-Class/Best-in-Class Therapies with Five Programs Expected in Clinical Development in Next 24 Months

Retrieved on: 
Friday, November 3, 2023
GMG, BioCryst Pharmaceuticals, FDA, Research, Patient, Drug design, IgA nephropathy, Plasma, CAD, Lupus nephritis, KLK5, Genetic disorder, RESEARCH, C2, DME, Eculizumab, Infection, Injection, Skin, Diabetes, Autoantibody, Ryan Murphy, Edema, Netherton, R, Autoimmune hemolytic anemia, HAE, Kallikrein, Growth, Disease, Dehydration, Muscle weakness, Immune system, Hemolysis, Solubility, Netherton syndrome, Clinical trial, Paratriathlon, Eye, Ravulizumab, Cold agglutinin disease, PARK, IP, SPINK5, Fine chemical, Pharmaceutical industry, Vaccine

A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .

Key Points: 
  • A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .
  • The team is excited to share our approach, and our expanded pipeline of new programs, at our R&D Day,” said Jon Stonehouse, president and chief executive officer of BioCryst.
  • The disease is caused by the deficiency of a natural inhibitor (SPINK5) of KLK5, a serine protease responsible for regulating skin shedding.
  • Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections.

GMG Provides Commercialisation Update on Energy Savings Coating THERMAL-XR(R)

Retrieved on: 
Monday, October 30, 2023
Documentation, Heat, Gap analysis, ISO9001, GMG, Accreditation, EPA, Marketing, Heating, ventilation, and air conditioning, AAON, The Company, Stage One, Safety, ISO, Quality management, Typesetting, Refrigeration, Ventilation

BRISBANE, AUS, Oct 30, 2023 - (ACN Newswire) - Graphene Manufacturing Group Limited (TSXV: GMG) ("GMG" or the "Company") is pleased to provide a business update on the commercialisation progress of THERMAL-XR(R) powered by GMG Graphene.

Key Points: 
  • BRISBANE, AUS, Oct 30, 2023 - (ACN Newswire) - Graphene Manufacturing Group Limited (TSXV: GMG) ("GMG" or the "Company") is pleased to provide a business update on the commercialisation progress of THERMAL-XR(R) powered by GMG Graphene.
  • GMG has now received forward orders of over AU$400k for THERMAL-XR(R) from various distributors and customers worldwide.
  • Preparations for the early 2024 product launch in the USA by Nu-Calgon are advanced with marketing, sales and customer engagement activities well progressed supported by continuing demonstrations of successful energy savings results.
  • A recent demonstration project in Texas achieved an estimated 36% energy savings result, as per Figure 1.

Graphene Manufacturing Group Board Appoints Former Wall Street Veteran and Manufacturing Entrepreneur Jack Perkowski to Chair of Board of Directors

Retrieved on: 
Tuesday, October 24, 2023
Partner, Harvard Business School, Paine Webber, ASIMCO, GMG, Energy, Chairperson, Triple accreditation, Chair, Wall Street, The Company, Head, UBS, Graphene, ASIMCO Technologies, Audit committee, Management, Yale University

In 1991, Mr. Perkowski moved to Hong Kong in order to focus on the development of Asia and China, and in 1994 founded Beijing based ASIMCO Technologies.

Key Points: 
  • In 1991, Mr. Perkowski moved to Hong Kong in order to focus on the development of Asia and China, and in 1994 founded Beijing based ASIMCO Technologies.
  • GMG's CEO Craig Nicol stated, "I'm very excited to see Jack becoming Chair of the Board of Directors of the Company to support our progression into a commercial manufacturing operation.
  • I also want to thank Guy Outen for his role as Chair of the Board of Directors for the past four years - including his work as Audit Committee Chair."
  • Jack Perkowski, GMG's Chair added, "I'm delighted to be appointed by my fellow Directors to Chair of the Board of the Company.