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Martin Marandon-Carlhian ... (+2)
  • Martin Marandon-Carlhian
  • Stephane Houri
Martin Marandon-Carlhian ... (+2)
  • Martin Marandon-Carlhian
  • Stephane Houri
Jacob Mekhael ... (+6)
  • Jacob Mekhael
  • Livio Luyten
  • Michiel Declercq
  • Thomas Couvreur
  • Thomas Vranken
  • Wim Hoste

Morning Notes : ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONW...

: ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONWD BB, JDEP NA

Jacob Mekhael
  • Jacob Mekhael

argenx FDA FAERS reporting flags Vyvgart Hytrulo in routine update

Yesterday during trading hours, the FDA flagged worsening of CIDP with Vyvgart Hytrulo as a new safety signal via a routine update to the FDA adverse event reporting system (FAERS), which sent the argenx' stock down approx. 8%. While CIDP worsening was also reported in patients switching between treatments from IVig to SCig in the PATH study, physicians navigate treatment switches carefully, and based on argenx' own post-marketing surveillance,

Jacob Mekhael
  • Jacob Mekhael

argenx FIRST LOOK: ARGX-119 Ph1b shows POC in CMS, Ph3 in preparation

argenx announced its plan to advance the clinical development of ARGX-119 (muscle-specific kinase [MuSK] agonist antibody) to a registrational study in patients with congenital myasthenic syndromes (CMS) following the analysis of topline data from the phase 1b study, which showed consistent improvements through the 12-week study across multiple efficacy scores. This marks the 3rd candidate to advance to phase 3 from argenx' internal pipeline, which in our view supports the company's future growt...

Guy Sips ... (+6)
  • Guy Sips
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Kristof Samoy
  • Lynn Hautekeete
  • Thomas Couvreur
 PRESS RELEASE

argenx Advances Clinical Development of ARGX-119 in Congenital Myasthe...

argenx Advances Clinical Development of ARGX-119 in Congenital Myasthenic Syndromes Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of p...

Anthony Dick ... (+2)
  • Anthony Dick
  • Michael Foundoukidis
Anthony Dick ... (+2)
  • Anthony Dick
  • Michael Foundoukidis
Jacob Mekhael
  • Jacob Mekhael

argenx European Commission approves Vyvgart SC in CIDP

argenx announced that the European Commission (EC) approved Vyvgart SC for the treatment of adults with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins, which comes in line with expectations following the positive CHMP opinion issued in April 2025. We anticipate a steady country by country EU launch, and continue to expect the US to remain the main driver for Vyvgart's commercial launch. We currently estimate approx. $ 1.1bn in peak sales for CI...

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