Sector News

argenx reports Q3 2021 financial results and provides business update

October 31, 2021
Life sciences

argenx (Euronext & Nasdaq: ARGX), a global immunology companycommitted to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced its third quarter 2021 financial results and provided a business update and outlook for the remainder of the year.

“With three parallel regulatory reviews in our key priority territories of the U.S., Japan and the EU and the simultaneous build-out of our respective commercial organizations, we are well-positioned for the planned global launch of efgartigimod for the treatment of generalized myasthenia gravis. In order to optimize our strategy to make efgartigimod available to patients in need across the world, we are pursuing innovative partnerships, such as the strategic partnership with Zai Lab in China and the agreement with Medison in Israel which we are excited to announce today,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

“As part of our commitment to becoming a fully-integrated, global immunology company, we are expanding our efgartigimod development plan to be in at least 15 indications by 2025 while also advancing a series of additional high-potential programs emerging from our Immunology Innovation Program. This includes a first-in-class C2 inhibitor, ARGX-117, which is on track to begin the first Phase 2 trial in multifocal motor neuropathy patients by the end of this year. Our growing commercial infrastructure along with our expanding pipeline ambitions provide considerable opportunity for argenx to deliver long-term, sustainable growth,” concluded Mr. Van Hauwermeiren.

THIRD QUARTER 2021 AND RECENT BUSINESS UPDATE

Three global regulatory reviews ongoing for FcRn antagonist efgartigimod for the treatment of gMG

  • Biologics License Application (BLA) under review with U.S. Food and Drug Administration (FDA) with target action date of December 17, 2021 under Prescription Drug User Fee Act (PDUFA)
  • Marketing Authorization Application (J-MAA) under review with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) with anticipated approval in first quarter of 2022
  • MAA under review with European Medicines Agency (EMA) with anticipated approval in second half of 2022
  • Zai Lab on track with expected regulatory discussions with National Medical Products Administration (NMPA) for approval in China
  • Signed exclusive partnership agreement with Medison to commercialize efgartigimod for gMG in Israel; under agreement, Medison will also be responsible for seeking requisite regulatory approvals
  • Field teams onboard in U.S. and Japan, including 70 U.S. and 24 Japan sales representatives

READ MORE

by argenx, Press Release

Source: argenx.com

comments closed

Related News

April 20, 2024

CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

Life sciences

CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs.

April 20, 2024

FUJIFILM plans $1.2 billion investment in major US manufacturing facility

Life sciences

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.

April 20, 2024

Sanofi cuts staff in Belgium as early-stage research dwindles

Life sciences

Sanofi’s global restructuring and downsizing is now fully underway, with layoffs stretching to the company’s Belgian offices. Belgian newspaper De Tijd reports that 67 employees have been laid off at a site in Ghent and 32 jobs are on the chopping block at Sanofi’s Belgium HQ in Diegem.

How can we help you?

We're easy to reach