>Positive phase II results - Argenx has announced positive results for the phase II of the phase II/III study (ALKIVIA) evaluating efgartigimod in patients with three sub-types of idiopathic inflammatory myopathies (or myositis). With no quantified press release for the time being, the group has indicated that the study demonstrates a statistically significant therapeutic effect in favour of efgartigimod on the total improvement score (TIS) at week 24 (primary endpoin...
>Résultats de phase 2 positifs - Argenx annonce des résultats positifs de la partie phase 2 de la phase 2/3 (ALKIVIA) évaluant efgartigimod chez des patients dans trois sous-types de myopathies inflammatoires idiopathiques (ou myosites). Sans communiqué de résultats chiffrés à ce stade, la société indique que l’étude a démontré un effet thérapeutique en faveur d’efgartigimod statistiquement significatif sur le score total d’amélioration (TIS) à la semaine 24 (critère ...
argenx announced that it is advancing clinical development of SC efgar in idiopathic inflammatory myopathies (myositis). The ongoing seamless Ph2/3 study is a basket trial across three myositis subsets, IMNM, ASyS and DM, each of which will continue into the Ph3 part. Furthermore, following the strong Q3 update, we have adjusted our model to reflect the sustained strong commercial uptake for Vyvgart in myasthenia gravis (MG), as well as the solid start in CIDP. On the other hand, we have removed...
argenx Advances Clinical Development of Efgartigimod SC in Idiopathic Inflammatory Myopathies Phase 2 data establish proof-of-concept of efgartigimod SC in myositis Enrollment to continue in Phase 3 across all three subtypes (IMNM, ASyS, DM) under evaluation in ALKIVIAPotential for efgartigimod SC to be first targeted approach for myositis patients who have limited treatment options November 20, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune dise...
Yesterday before US market opens, argenx and partner Zai Lab announced China's national medical products administration (NMPA) approved the supplemental (sBLA) for Vyvgart Hytrulo in adults with CIDP. We anticipate approx. $600m in peak sales for CIDP in China, and pencil down 15% royalties to argenx from Zai Lab. Looking ahead, the candidate has been submitted to regulatory agencies in Europe and Japan, with approvals in CIDP expected in 2025, while regulatory submission in Canada is due by YE2...
argenx and Zai Lab Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in China First and only NMPA-approved treatment for patients with CIDP in China Second VYVGART Hytrulo indication approved in China November 11, 2024 – 7:30am ET Amsterdam, the Netherlands— argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg (5.6ml)/vial [efgartigimod alfa inject...
A director at Argen X SE sold 1,218 shares at 542.600EUR and the significance rating of the trade was 99/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly show...
argenx to Participate at Upcoming Investor Conferences November 5, 2024Amsterdam, 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 upcoming investor conferences in November: Guggenheim Inaugural Healthcare Innovation Conference. Fireside chat on Tuesday, November 12, 2024 at 2:30 p.m. ET in Boston, MA. Jefferies London Healthcare Conference. Management will participate in investor meeting...
>Forecasts beaten for sales and EBIT - Q3 sales were up by 74% y-o-y and 34% q-o-q to $ 573m (US $ 492m, Japan $ 24m, EMEA $ 46m and $ 11m supply in China), reflecting both strong demand for products (i.e. Vyvgart and Vyvgart Hytrulo) and excellent commercial execution. Note that this quarter includes CIPD sales for the first time. The group provides no information on the breakdown by indication but indicates that the launch of this new indication “got off to an impr...
>Au-dessus des attentes au niveau des ventes et de l’EBIT - Les ventes T3 progressent de 74% y-o-y et de 34% q-o-q pour atteindre 573 M$ (USA à 492 M$, Japon 24 M$, EMEA 46 M$ et 11 M$ de fourniture en Chine), reflétant à la fois la forte demande des produits Vyvgart et Vyvgart Hytrulo ainsi que l’excellente exécution commerciale. Ce trimestre intègre pour la première fois les ventes dans CIDP. La société ne communique pas sur le split par indication mais indique qu...
argenx reported a strong quarter with Vyvgart sales coming in at $ 573m, 8% above BBG analyst consensus, showcasing the robustness of the company's commercial engine. We note that the company reached operating profitability for the quarter despite increased investments in R&D and SG&A. In the pipeline, timelines are reiterated and we look ahead to the upcoming go/no go decision for myositis by YE24 and an update on the BP study. We reiterate our Accumulate and € 530.
argenx Reports Third Quarter 2024 Financial Results and Provides Business Update $573 million in third quarter global net product sales CIDP global expansion on track, with decisions on approval under review in Japan, Europe, China, and Canada Management to host conference call today at 1:30 PM CET (8:30 AM ET) Regulated information - Inside information October 31, 2024 7:00AM 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 its third...
argenx to Report Third Quarter 2024 Financial Results and Business Update on October 31, 2024 October 24, 2024Amsterdam, 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, October 31, 2024 at 1:30 PM CET (8:30 AM ET) to discuss its third quarter 2024 financial results and provide a business update. A webcast of the live call may be accessed on the Investors section of the argenx website at . A...
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