We updated our numbers after DEME announced that it has signed an agreement to acquire Havfram (employing around 50 people), an international offshore wind contractor based in Norway. The agreement represents an aggregated transaction value of +/- 900m including the remaining Capex needed to complete 2 vessels. This strategic acquisition aligns with DEME's ambition to expand its footprint in the offshore wind energy market and enhances its competitive positioning in turbine and foundation instal...
Last Friday evening, Autolus announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for Aucatzyl (CD19 CAR-T) in adult relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in line with the expected timeline. Looking ahead, Autolus will report its 1Q25 results on 8 May, where the first quarter US sales of Aucatzyl will be reported and will give us a quantitative view on the launch momentum – note that ...
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...
Today we initiate coverage on the Dutch biotech company Merus. Merus offers a compelling investment opportunity, with its innovative antibody platforms, promising lead asset petosemtamab, robust pipeline, and strategic partnerships. The company's strong financial position and ambitious plans for 2025 and beyond position it to make a significant impact on the landscape of cancer treatment. We initiate coverage with a $ 59 TP and Buy rating.
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...
Autolus Therapeutics Announces License of AUCATZYL® (obecabtagene autoleucel) Issued by UK MHRA for Adult Patients (≥ 18 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)(1) UK Medicines and Healthcare products Regulatory Agency (MHRA) authorisation based on FELIX clinical trial of obecabtagene autoleucel in adult patients with r/r B-ALL1AUCATZYL® licensed from MHRA under ‘conditional marketing authorisation’, meaning that the MHRA will review new efficacy and safety information at least once every year1 Investors, US and UK National, Medical and ...
Yesterday, Autolus hosted an R&D day where it shared initial data from the phase 1 trial of obe-cel (CD19 CAR-T) in r/r SLE which showed that 3/6 patients achieved complete renal response (CRR). The company has aligned with the FDA on the route to market, and plans to initiate a pivotal phase 2 trial by YE25. In addition, Autolus announced its plan to evaluate obe-cel in progressive MS with a dose escalation trial due to begin by YE25. We reiterate our $ 10 TP and Buy rating.
Merus gibt Annahme von Abstract zur Präsentation auf der ASCO®-Jahrestagung 2025 bekannt - Vorläufige klinische Daten zu Petosemtamab in Kombination mit Pembrolizumab bei 1L PD-L1+ r/m HNSCC für Posterpräsentation ausgewählt - Telefonkonferenz am Donnerstag, 22. Mai, um 17:30 Uhr Eastern Time zur Besprechung des vollständigen ASCO®-Datensatzes UTRECHT, Niederlande, und CAMBRIDGE, Massachusetts, April 24, 2025 (GLOBE NEWSWIRE) -- N.V. (Nasdaq: MRUS) (Merus, das Unternehmen, wir oder unser), ein Onkologieunternehmen, das innovative, multispezifische Volllängen-Antikörper und Anti...
Merus annonce l’acceptation de son résumé pour présentation au congrès annuel 2025 de l’ASCO® - Le pétosemtamab en association avec le pembrolizumab en traitement de première intention d'un CETC r/m PD-L1+ : premières données cliniques provisoires sélectionnées pour une présentation sous forme d’affiche - Conférence téléphonique le jeudi 22 mai à 17 h 30 heure de l’Est (« HE ») pour discuter de l’ensemble de données complet présenté lors de l’ASCO® UTRECHT, Pays-Bas et CAMBRIDGE, Massachusetts, 24 avr. 2025 (GLOBE NEWSWIRE) -- N.V. (Nasdaq : MRUS) (« Merus », la « Société »...
Autolus Therapeutics Highlights Advancing Autoimmune Pipeline at R&D Investor Event Company outlined potential for value creation driven by obe-cel across multiple B cell driven malignancies and autoimmune diseases, including acute lymphoblastic leukemia (ALL), lupus nephritis (LN) and multiple sclerosis (MS)Preliminary data in initial six patient cohort treated in Phase 1 trial in systemic lupus erythematosus (SLE) support progressing obe-cel into a planned Phase 2 pivotal study in lupus nephritis; first patient expected to be dosed in Phase 2 trial by year-end 2025Company plans to advance...
Merus Announces Abstract Accepted for Presentation at the 2025 ASCO® Annual Meeting - Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC interim clinical data selected for poster presentation - Conference call on Thursday, May 22 at 5:30 p.m. ET to discuss full ASCO® data set UTRECHT, The Netherlands and CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), today ann...
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