reports
- ING Helpdesk
Benelux Morning Notes
Arcadis: Further in German rail. CVC Capital Partners: They beat, they score. D'Ieteren: US Belron peer Boyd 4Q24 a bit ahead, weak 2025 early outlook. Fastned: Preview FY24. IBA: 2H24 better REBIT, net cash but outlook on the low side. Proximus: Interim leadership announced. UCB: Peer Immunovant reports mixed results in gMG Zabka: Peer Jeronimo Martins FY24 results
- Jacob Mekhael
MaaT Pharma FIRST LOOK: Positive DSMB review for lead product MaaT013 ...
MaaT announced that the independent data safety monitoring board (DSMB) completed its final safety assessment of the pivotal phase 3 (ARES) trial of MaaT013 in 3L aGvHD, which was in line with previous evaluations confirming the favourable benefit/risk ratio of the product. As a reminder, MaaT013 met its primary endpoint in the phase 3 (ARES) trial, and results presented in January 2025 demonstrated a 28 day GI-ORR of 62%, which came in above expectations. Looking ahead, we look forward to the r...
- Sharad Kumar S.P
Gimv Bart Troubleyn to lead Gimv Anchor
Following Gimv's CMD (Jan'25) during which it announced its new strategy, deeper collaboration with WorxInvest, and launched ‘Gimv Anchor', Gimv has appointed Bart Troubleyn as the Head of Gimv Anchor (from mid-April onwards). Bart will also become a member of Gimv's Executive Committee. In his role, Bart will be working closely with all Managing Partners and teams of individual Gimv platforms in terms of both deal sourcing and in further strengthening the active value creation across platforms....
- Jacob Mekhael
UCB FIRST LOOK: New data on pyrimidine nucleoside therapy in TK2d at M...
UCB presented results from studies involving doxecitine (dC) and doxribtimine (dT) (pyrimidine nucleoside therapy) in people living with thymidine kinase 2 deficiency (TK2d), at the MDA Clinical and Scientific Conference, being held 16-19 March in Dallas. The improvements in survival and functional outcomes highlight the potential of doxecitine and doxribtimine in treating TK2d, which is an ultra-rare genetic mitochondrial disease with no approved therapies, and has a prevalence of 1.64/1m peopl...
- Guy Sips
- Jacob Mekhael
- Sharad Kumar S.P
- Guy Sips
- Thomas Vranken
Biotalys FIRST LOOK: Good financial management; but focus could be on ...
In FY24, Biotalys optimized its capital resources, achieving a significant reduction in operating expenses while strengthening its balance sheet through a successful private placement. Looking ahead, they plan to further advance their product portfolio and develop novel modes of action, as well as expand options to scale and produce their biobased solutions. So we saw in FY24 good financial management - runway reaching into May-26 - but focus could be on some operational hiccups.
- ING Helpdesk
MaaT Pharma annonce la conclusion positive de l’examen final du DSMB p...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT : MAAT - la « Société »), société de biotechnologies en stade clinique avancé, leader dans le développement de Microbiome Ecosystem TherapiesTM (MET)1 visant à améliorer la survie des patients atteints de cancers grâce à la modulation du système immunitaire, annonce, après avoir reçu récemment l’approbation de son Plan d'Investigation Pédiatrique (PIP) par le Comité Pédiatrique de l'EMA, que le DSMB a réalisé sa dernière revue de sécurité pour l'essai clinique pivotal de Phase 3 ARES, une étude européenne, ouverte, à un seul bras et ...
MaaT Pharma Announces Positive Outcomes from Final DSMB Meeting for Pi...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced, after recently receiving the approval of its Pediatric Investigation Plan (PIP) by the EMA Pediatric Committee, that the DSMB completed its final safety assessment of the pivotal Phase 3 trial ARES, a single-arm, open-label, multicenter European study evaluating the efficacy and safety of MaaT013 in acute ...
- ING Helpdesk
- Jacob Mekhael
MaaT Pharma MaaT013 PIP approval clears path for MAA submission in Jun...
MaaT announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved the pediatric investigation plan (PIP) for MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD). The approval of the pediatric investigation plan (PIP) for MaaT013 in aGvHD is a positive step for the company as an approved PIP is a prerequisite for filing a marketing authorization application (MAA). As such, MaaT is on track to submit the MAA for MaaT013 in Europe in June 2025, which m...
MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on ...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced today that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved the Pediatric Investigation Plan (PIP) for MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD). “We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opi...
MaaT Pharma reçoit un avis positif du Comité Pédiatrique de l'EMA pour...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT : MAAT - la « Société »), société de biotechnologies en stade clinique avancé, leader dans le développement de Microbiome Ecosystem TherapiesTM (MET)1 visant à améliorer la survie des patients atteints de cancers grâce à la modulation du système immunitaire, annonce aujourd'hui que le Comité Pédiatrique (PDCO) de l'Agence européenne des médicaments (EMA) a approuvé le plan d'investigation pédiatrique (PIP) de MaaT013 pour le traitement de la maladie aiguë du greffon contre l'hôte (aGvH). « Nous sommes très satisfaits du dialogue con...
Gimv NV: 1 director
A director at Gimv NV bought 2,750 shares at 36.720EUR and the significance rating of the trade was 60/100. 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 showin...
- Thomas Vranken
UCB J&J and Amgen data drops at AAD 2025
At the American Academy of Dermatology (AAD) 2025 conference, UCB presented strong 5-year follow-up data for Bimzelx in plaque psoriasis and 2-year follow-up in hidradenitis suppurativa. Meanwhile, Johnson & Johnson also announced Phase 3 data for its oral drug icotrokinra in psoriasis, showing promising results and planning further trials. In addition, Amgen reported positive Phase 3 results for rocatinlimab in atopic dermatitis. These developments highlight significant advancements in dermatol...
- Guy Sips
- Michiel Declercq
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Biotalys Positive first field trial results with 2nd biocontrol BioFun...
Biotalys announced strong results from field trials of its second biofungicide BioFun-6, which targets Botrytis and powdery mildew in fruits and vegetables. The trials showed BioFun-6 effectively controlled fungi compared to synthetic and biological solutions at lower dosage rates than Evoca. While further field trials still need to be conducted before a regulatory filing, we estimate BioFun-6 could reach the market by the end of the decade and reach a significant share of the today € 1.2bn mark...
- Hilde Van Boxstael
- Kristof Samoy
- Thomas Couvreur
- Thomas Vranken
- Wim Lewi
- Thomas Vranken
UCB FIRST LOOK: 5Y PsO and 2Y HS data further cement Bimzelx' leadersh...
Additional data presented at AAD 2025 further cement Bimzelx' leadership in the IL-17 space for PsO and HS. In PsO, efficacy was well maintained from previous 4-year data into the 5-year follow-up with 67.7% PASI100 and 84.9% PASI90. In HS, additional 2-year data saw 55.7% pts with draining tunnels at baseline, a particularly painful manifestation, reaching clearance after two years. We reiterate our confidence in Bimzelx as an rising leader in the dermatology/rheumatology space, and confirm our...
- David Vagman
- CFA
- Maxime Stranart
UCB/Strengthening its Immunology portfolio/BUY
We reiterate our BUY rating on UCB and increase our target price from €212 to €220 on the back of a slight increase in Bimzelx's long-term peak sales and Evenity, which is now profitable in Europe. We continue to view UCB's risk/reward balance as favourable, with the group pipeline accounting for only 6% of Enterprise Value. This allows UCB to have a decade-plus visibility on top- and bottom-line growth, in our view. We believe UCB offers growth at a reasonable valuation, the company now trading...
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