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- ING Helpdesk
Benelux Morning Notes
ASM International: 1Q24 Preview - focus on order intake. Barco: Preview 1Q24 - a slow start to the year. B&S Group: Solid year-end performance and healthy outlook. Fastned: 1Q24 trading update – disappointing charging volume. Staffing: Hays' 3Q23/24 trading update - warning on 3Q23/24, weaker trends
- Guy Sips
- Kristof Samoy
- Michiel Declercq
- Thomas Vranken
- Wim Lewi
- Thomas Vranken
argenx FIRST LOOK: Additional CIDP data at AAN
argenx announced additional detail on its Phase 3 ADHERE data with Vyvgart Hytrulo, showcasing its speed of onset and depth of response. We believe that Vyvgart Hytrulo is well positioned vs. the approved standard-of-care IVIg/SCIg across patient types, and look forward to the FDA decision (PDUFA: June 21, 2024). € 435 TP and Buy rating reiterated.
argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive ...
argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease ADHERE data show VYVGART® Hytrulo has potential to be first advancement for CIDP patients in 30 years Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART® treatment April 16, 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, ...
- David Seynnaeve
- PhD
argenx - New CIDP & gMG data further underlines VYVGART (Hytrulo)'s va...
• ARGX shared additional results from the ADHERE (open-label) study and real-world data from gMG patients at the AAN Annual Meeting. • Data indicates rapid, deep, and clinically meaningful/sustained improvements in CIDP & with ability to reduce steroid burden (gMG). • We expect a positive outcome of the decision on regulatory approval for CDP by June 21 (85% LoA, +4% impact on TP) and currently project low double-digit million in sales this year. This might seem rather conservative (vs. gMG init...
- Kris Kippers
Barco - Patience is a virtue - 2024 starts slow- M&A?
• 2024 is not expected to start very well, driven by exceptional items, timing of certain events as well as China that is not (yet) rebounding, anti-bribery linked. Hence, we now bank on a Q1 of -14% sales drop from -7% before• Our estimates are fine-tuned slightly on sales and EBITDA to reflect the slower growth in H1 and some operating deleverage effect because of this• Whereas trading is not yet excellent, we believe that the worst is clearly behind and we see some short-term triggers such as...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Thomas Vranken
- Wim Lewi
- Damien Choplain
- Martial Descoutures
- Damien Choplain
- Martial Descoutures
Argenx : Positive phase II results in Sjögren’s disease
>Phase II results support a move to phase III - Argenx announced positive results for the phase II RHO study evaluating efgartigimod in patients suffering from Sjögren’s disease (SjD). The company has not announced any figures for the results at this stage since they will be presented at an upcoming medical conference. Based on these results, the company envisages continuing the development of efgartigimod in phase III, which could lead to a commercial launch in this ...
- Damien Choplain
- Martial Descoutures
- Damien Choplain
- Martial Descoutures
Argenx : Résultats de phase 2 positifs dans le syndrome de Sjögren
>Phase 2 soutenant un passage en phase 3 - Argenx annonce des résultats positifs de la phase 2 RHO évaluant efgartigimod chez des patients atteints du syndrome de Sjögren (SjD). La société ne communique aucun résultat chiffré à ce stade puisqu’ils seront présentés lors d’un prochain congrès médical. Sur la base de ces résultats, la société envisage de poursuivre le développement d’efgartigimod en phase 3, ce qui pourrait conduire à un lancement commercial dans cette i...
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
argenx FIRST LOOK: Proof of concept in primary Sjogren's disease
argenx announced favourable Phase 2 data for its RHO study in primary Sjogren's disease (SjD), supporting further development into Phase 3. While no details on the results were given, the go decision was supported by the safety, efficacy and biomarker results from the study. argenx thus enters in close pursuit of J&J's nipocalimab, which also reported positive SjD Phase 2 data earlier this year with plans to pursue further. We look forward to additional study details to compare both assets in th...
argenx Advances Clinical Development of Efgartigimod in Primary Sjogre...
argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease RHO study supports proof-of-concept in primary Sjogren’s disease Decision informed by favorable safety profile and consistency across efficacy and biomarker measures March 27, 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 diseases, today announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary Sjogren’s disease (SjD),...
- David Seynnaeve
- PhD
argenx - GO for Sjögren's
*Based on Ph2 RHO study data, ARGX decided to advance Efgar into Ph3 development for Sjögren's. Data detail will be shared at an upcoming conference.*Remember that RHO was meant to be a signal-finding study (vs. dose-finding for J&J's Ph2 with competitor anti-FcRn Nipo which enrolled > 160 pts), hence only a limited number of patients were enrolled not making the primary endpoint powered for statistical significance. IR confirmed, however, that strong improvements were seen for the com...
argenx Announces Annual General Meeting of Shareholders on May 7, 2024
argenx Announces Annual General Meeting of Shareholders on May 7, 2024 March 26, 2024 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 7, 2024 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 Meeting of sharehold...
- Kristof Samoy
- Thomas Vranken
- Wim Lewi
- Thomas Vranken
argenx FIRST LOOK: Japanese nod on ITP
argenx obtains Japanese approval with IV Vyvgart for the treatment of ITP. Although the trial with SC Vyvgart recently did not demonstrate benefit (which led to scrapping of ITP filings in the US and EU), argenx could move forward with IV data alone in Japan, and has now gained regulators' nod. We anticipate Vyvgart to be mainly used in heavily pre-treated patients with ITP peak sales slightly north of € 100m, and mainly look forward to the upcoming CIDP approval and Phase 2 readouts in Sjogren'...
argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for ...
argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia VYVGART® now approved in Japan for both generalized myasthenia gravis and primary immune thrombocytopenia (ITP) Regulatory decision in Japan represents first global approval for VYVGART in ITP March 26, 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 diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) app...
- David Seynnaeve
- PhD
argenx - First non-gMG approval for VYVGART
*This morning, ARGX announced approval of VYVGART for the treatment of ITP in Japan. News was expected around this time of the year and the approval is no surprise to us given the strong ADVANCE-IV dataset.*We don't expect a major market reaction following this approval as the commercial potential was burned following the ADVANCE-SC setback. We consider 1/ the readouts in Sjogren's disorder and PC-POTS in H1 still (indications still upside in our model) and 2/ the outcome of the regula...
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