argenx received a positive opinion from the CHMP of the EMA for Vyvgart in treating CIDP in adults with progressive or relapsing disease after prior treatment with corticosteroids or immunoglobulins. The European Commission will now decide on the regulatory submission within 60 days. Vyvgart is the first novel CIDP treatment in over 30 years and could potentially be self-administered. This approval is expected to lead to significant sales in the EU, with EU peak sales estimated at $1.1bn (KBCSe...
argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDPFirst novel mechanism of action for CIDP treatment in more than 30 yearsCHMP positive opinion based on ADHERE data, the largest ever CIDP clinical trial European Commission (EC) decision on marketing authorization application (MAA) expected within approximately two months April 28, 2025, 07:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a...
argenx Announces Annual General Meeting of Shareholders on May 27, 2025 April 11, 2025, 10:01 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Annual General Meeting of shareholders will be held at 13:00 CET on Tuesday, May 27, 2025 at the Hilton Amsterdam Schiphol at Schiphol Boulevard 701, 1118 BN Schiphol, the Netherlands.The shareholders and all other persons with meeting rights are invited to attend the Annual General Meet...
argenx obtained FDA approval for a PFS presentation of Vyvgart Hytrulo for self-injection for patients with AChR+ gMG or CIDP. The 20-30 second injection can now be administered by patients themselves after proper instruction, freeing them to receive treatment in healthcare settings, at home or on the go. With no specific monitoring or training requirements, the label provides a lot of flexibility for patients. We see the approval as the next phase in maintaining Vyvgart's launch momentum as it ...
argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringeSelf-injection provides gMG and CIDP patients with flexibility for when and where to receive treatment – at home, while ‘on the go’ or in a healthcare setting Approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies April 10, 2025...
Trumps reciprocal tariffs caused a massive blow to equity markets, following a pressured period of escalating trade wars. Retaliatory measures can further heavily damage market confidence, as seen Friday when China announced their 34% tarrif of US goods. International trade policies have never moved this erratic and untransparant, with uncertainty and volatility being the baseline for now. In this report we highlight the key stocks in our coverage relevant to this discussion.
argenx Highlights VYVGART Data at AAN 2025 Setting New Standard in Sustained Efficacy and Improved Quality of Life Measures for Patients Living with gMG and CIDP ADAPT-NXT data demonstrate consistent, sustained disease control across dosing schedules, further supporting individualized VYVGART dosing for gMG patients ADHERE+ oral presentation features long-term CIDP data demonstrating VYVGART Hytrulo’s durable efficacy, sustained functional improvements and favorable safety profileargenx continues to advance a robust neuromuscular pipeline of clinical candidates; first-in-human data of ARG...
argenx Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual Meeting Largest safety data set on FcRn blocking demonstrates consistent, favorable safety profile of VYVGART and VYVGART HytrulogMG patients on VYVGART achieve rapid, substantial, and sustained efficacy across multiple dosing regimens, supporting individualized treatment approachADHERE+ oral presentation builds upon evidence of VYVGART Hytrulo driving improved functional ability in CIDP Amsterdam, the Netherlands – March 7, 2025 – argenx SE (Eurone...
argenx reported its FY24 financial results, underscoring Vyvgart's sustained commercial momentum and the company's pivot toward sustainable profitability. Despite increasing competition, we see no signs of stopping. For 2025, we mainly look forward to Vyvgart's ramp-up in CIDP, its PFS approval (PDUFA April 10), a PoC readout in LN and ARGX-119's first clinical results in CMS. We maintain our € 670 TP and Accumulate rating.
argenx Reports Full Year 2024 Financial Results and Provides Fourth Quarter Business Update $737 million in fourth quarter and $2.2 billion in full year global product net sales Received positive CHMP recommendation for VYVGART pre-filled syringe for gMG, enabling launch in the EU; FDA PDUFA (gMG and CIDP) on track for April 10 10 Phase 3 and 10 Phase 2 studies across pipeline ongoing in 2025, positioning for next wave of growth Recognized one-time tax benefit of $725 million related to previously unrecognized deferred tax assets Management to host conference call today at 2:30 PM CET...
argenx to Present at TD Cowen 45th Annual Healthcare Conference February 25, 2025Amsterdam, 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 Tim Van Hauwermeiren, Chief Executive Officer, will present at the TD Cowen 45th Annual Healthcare Conference on Monday, March 3, 2025 at 11:50 a.m. ET. A live webcast of the presentation may be accessed on the Investors section of the argenx website at . A replay of the webcast will be available on the argenx websi...
argenx to Report Full Year 2024 Financial Results and Fourth Quarter Business Update on February 27, 2025 February 20, 2025Amsterdam, 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 27, 2025 at 2:30 PM CET (8:30 AM ET) to discuss its full year 2024 financial results and provide a fourth quarter business update. A webcast of the live call may be accessed on the Investors section of th...
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