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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...

Jacob Mekhael
  • Jacob Mekhael

Galapagos Appoints Aaron Cox as new CFO

Galapagos announced the appointment of Aaron Cox as CFO, effective 7 July 2025. Most recently, he served as Executive VP and CFO at Horizon Therapeutics. Aaron replaces Thad Huston, who joined Galapagos as CFO in 2023. With plans to explore strategic options for the cell therapy business, as well as plans to utilise the €3.3b cash (as of 1Q25) to build a new pipeline through business development, Aaron's network and experience in deal making will be key to Galapagos' strategy going forward. We r...

Hilde Van Boxstael ... (+3)
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Wim Lewi
Jacob Mekhael
  • Jacob Mekhael

Hyloris Agreement with Kuvatris could generate a priority review vouch...

Hyloris announced the signing of an R&D funding agreement of $ 2m (plus $ 1.6m equity investment) with Kuvatris to support the development and US approval of intravenous (IV) suramin to treat human African trypanosomiasis (HAT). Given the rare nature of HAT, the value of this program lies in its potential to secure a transferable PRV. Recent examples show PRVs being sold for $160m – Hyloris could get just over 50% of net proceeds, if successful. We see this as a creative deal to boost the compan...

 PRESS RELEASE

Galapagos benoemt Aaron Cox als Chief Financial Officer

Galapagos benoemt Aaron Cox als Chief Financial Officer Voormalig CFO van Horizon vervoegt Galapagos met diepgaande expertise in internationale bedrijfsfinanciering, fusies en overnames, bedrijfsontwikkeling en strategisch leiderschap Mechelen, België; 23 juni 2025, 07:30 CET; gereglementeerde informatie - voorwetenschap - Galapagos NV (Euronext & NASDAQ: GLPG) kondigde vandaag de benoeming aan van de heer Aaron Cox als Chief Financial Officer, met ingang van 7 juli 2025. De heer Cox volgt de heer Thad Huston op, die tot 31 juli 2025 bij het bedrijf zal blijven om een soepele overdracht t...

 PRESS RELEASE

Galapagos Appoints Aaron Cox as Chief Financial Officer

Galapagos Appoints Aaron Cox as Chief Financial Officer Former Horizon CFO joins Galapagos with deep expertise in international corporate finance, M&A, business development and strategic leadership  Mechelen, Belgium; June 23, 2025, 07:30 CET; regulated information – inside information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced the appointment of Mr. Aaron Cox as Chief Financial Officer, effective July 7, 2025. Mr. Cox succeeds Mr. Thad Huston, who will remain with the company through July 31, 2025, to ensure a smooth transition of responsibilities.Aaron brings more than two ...

Galapagos NV: 1 director

A director at Galapagos NV bought 5,129 shares at 28.300EUR and the significance rating of the trade was 65/100. 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 s...

 PRESS RELEASE

argenx Announces European Commission Approval of VYVGART Subcutaneous ...

argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDPApproval based on ADHERE clinical trial, the largest study of CIDP patients to dateFirst novel mechanism of action for CIDP treatment in more than 30 years June 20, 2025, 7:00 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the liv...

Jacob Mekhael
  • Jacob Mekhael

Galapagos GLPG5101 phase 1/2 r/r iNHL cohort differentiates with high ...

Galapagos presented new data from the ongoing Phase 1/2 (ATALANTA-1) study of GLPG5101 (CD19 CAR-T) at the International Conference on Malignant Lymphoma (ICML). Results from the r/r iNHL cohort (FL and MZL) showed a high complete response rate of 97%, higher than Yescarta's 75% CR rate (79% in FL, 75% in MZL) in the same patient population in the phase 2 (ZUMA-5) trial. Safety continues to be a differentiator with only 1 grade 3 ICANS (vs. 19% grade = 3 with Yescarta). All in all, a supportive ...

Hilde Van Boxstael ... (+5)
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Thomas Couvreur
  • Wim Hoste
  • Wim Lewi
 PRESS RELEASE

Galapagos Presented New Data at ICML 2025 From Cohort 3 of ATALANTA-1 ...

Galapagos Presented New Data at ICML 2025 From Cohort 3 of ATALANTA-1 in Relapsed/Refractory Indolent NHL Patients, Demonstrating High Complete Response and MRD Negativity Rates With CAR-T Candidate GLPG5101 Of the 34 patients enrolled in Cohort 3 of the ATALANTA-1 Phase 1/2 study, 32 received GLPG5101; 94% were infused with fresh CAR-T cells, and 93% were treated within seven days of manufacturing GLPG5101 demonstrated promising efficacy with durable CAR-T cell persistence and a favorable safety profile, including a 97% complete response rate, 100% MRD negativity in evaluable patients, su...

 PRESS RELEASE

Galapagos presenteerde nieuwe gegevens op ICML 2025 van Cohort 3 van d...

Galapagos presenteerde nieuwe gegevens op ICML 2025 van Cohort 3 van de ATALANTA-1 studie bij patiënten met recidief/refractair indolent NHL, en toonde hoge complete respons- en MRD-negativiteitspercentages aan met de CAR-T-kandidaat GLPG51 Van de 34 patiënten die werden ingeschreven in Cohort 3 van de ATALANTA-1 fase 1/2-studie, ontvingen er 32 GLPG5101; 94% kreeg verse CAR T-cellen toegediend, en 93% werd behandeld binnen zeven dagen na productie  GLPG5101 toonde veelbelovende werkzaamheid met een langdurige CAR T-cel persistentie en een gunstig veiligheidsprofiel, waaronder 97% complete...

Jacob Mekhael
  • Jacob Mekhael

Galapagos Updated NHL phase 1/2 GLPG5101 data at EHA shows decentralis...

Galapagos will present new data from the ongoing Phase 1/2 (ATALANTA-1) study of GLPG5101 (CD19 CAR-T) at the European Hematology Association (EHA) Congress, being held 12-15 June. The results demonstrate POC for a 7 day vein-vein de-centralised CAR-T manufacturing process. Combined with the previously reported safety differentiation, we believe this could support strategic discussions as the company is exploring such options for its cell therapy business. We reiterate our Buy rating and € 37 TP...

Guy Sips ... (+6)
  • Guy Sips
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Michiel Declercq
  • Thomas Vranken
  • Wim Lewi
Wim Lewi
  • Wim Lewi

Dollar Weakness The impact on our Benelux Coverage

In general, a weaker USD has a negative impact on Benelux stocks, particularly for companies with significant exports to the US. In this note we selected a list of companies with high US export exposure and we examine the potential impact on FY25 earninings. On top of the weak dollar, rising trade tensions or the introduction of tariffs further harm Benelux exporters. As the dollar depreciates against the euro, European goods become costlier for American consumers. At the same time, revenues ear...

 PRESS RELEASE

Galapagos to Present New ATALANTA-1 CAR-T Data at EHA 2025, Highlighti...

Galapagos to Present New ATALANTA-1 CAR-T Data at EHA 2025, Highlighting Low Toxicity and Rapid, Decentralized Delivery of Fresh, Early-Memory-Enriched GLPG5101 in R/R NHL Data reported from the ongoing ATALANTA-1 Phase 1/2 study in a heavily pretreated relapsed refractory non-Hodgkin’s Lymphoma (R/R NHL) patient population demonstrate low rates of high-grade toxicities Of the 64 patients enrolled, 61 received treatment, resulting in a 5% attrition rate, significantly lower than industry benchmarks. 95% of patients were infused with fresh, stem-like early memory CD19 CAR-T cell...

 PRESS RELEASE

Galapagos zal nieuwe ATALANTA-1 CAR-T data presenteren op EHA 2025, me...

Galapagos zal nieuwe ATALANTA-1 CAR-T data presenteren op EHA 2025, met lage toxiciteit en snelle, gedecentraliseerde toediening van vers, early-memory-verrijkt GLPG5101 bij R/R NHL Gegevens uit de lopende ATALANTA-1 fase 1/2-studie bij een zwaar voorbehandelde patiëntengroep met recidief/refractair non-Hodgkinlymfoom (R/R NHL) tonen lage percentages van hooggradige toxiciteiten aan Van de 64 ingeschreven patiënten werden er 61 behandeld, wat resulteerde in een uitvalpercentage van 5%, aanzienlijk lager dan de benchmarks. 95% van de patiënten werd geïnfuseerd met verse,...

Jacob Mekhael
  • Jacob Mekhael

argenx FIRST LOOK: Supportive Sjogren's and Myositis POC data at EULAR

argenx announced the presentation of POC results from phase 2 studies evaluating Vyvgart in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology (EULAR), being held 11-15 June. We believe the POC data, showing improvements in disease activity and functional outcomes support the continued development of Vyvgart, with phase 3 trials currently ongoing in both indications. In addition, Vyvgart was granted FDA fast track designation...

Jacob Mekhael ... (+3)
  • Jacob Mekhael
  • Lynn Hautekeete
  • Thomas Vranken
 PRESS RELEASE

argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Posit...

argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren’s Disease ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimodRHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren’s disease; program granted U.S. FDA Fast Track designationargenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren’s disea...

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