reports
- Guy Sips
Barco Model update as ‘recharging is key'
We updated our Barco model resulting in a lower € 13.2 Target Price (was 14.2) which is the average of by our updated DCF (€ 13.4) and SOTP (€ 13.0) valuation. As we think that the share price already takes into account a lot of the negative news, we maintain our Accumulate rating.
- Thomas Vranken
Onward Medical FIRST LOOK: First commercial sales for ARC-EX
Only days after its de novo FDA approval for ARC-EX in clinic use, Onward has realized its first sales of the device. The two initial customers are UW Medicine and Next Steps Chicago, which appears in line with the company's previously communicated limited launch strategy. We look forward to seeing more sales materialize over the year. We reiterate our € 10.4 TP and Buy rating.
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
MaaT Pharma MaaT013 phase 3 beats expectations in aGvHD, MAA submissio...
MaaT announced that the phase 3 trial of MaaT013 met its primary endpoint in 3L aGvHD with a day 28 GI-ORR of 62%, exceeding our expectations and coming in in-line with our blue-sky scenario being significantly above what was observed in the phase 2 trial, and more or less in line with results from the early access program (EAP). Additionally, the company unexpectedly reported survival data showing a survival probability of 54%, higher than the 15% observed in the literature for off-label option...
ONWARD Medical Announces First Commercial Sales of ARC-EX System
ONWARD Medical Announces First Commercial Sales of ARC-EX System UW Medicine and Next Steps Chicago both purchased systems in late December 2024 ARC-EX is the first and only FDA approved technology indicated to improve hand strength and sensation in people with spinal cord injury ARC-EX was named a 2024 TIME Magazine Best Invention EINDHOVEN, the Netherlands, Jan. 09, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord ...
MaaT Pharma Announces Positive Topline Results from the Pivotal Phase ...
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, today announced topline results from ARES, a pivotal, single-arm, open-label, multicenter European Phase 3 study evaluating the efficacy and safety of MaaT013 in acute Graft-versus-Host Disease patients with gastrointestinal involvement (GI-aGvHD) in third-line treatment, meaning refractory to steroids and refractor...
MaaT Pharma annonce des résultats positifs pour l'étude pivotale de Ph...
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 les résultats principaux d’ARES, une étude européenne pivotale de Phase 3 multicentrique, ouverte et à un seul bras, évaluant l'efficacité et la sécurité de MaaT013 chez des patients atteints de la maladie aiguë du greffon contre l'hôte avec atteinte gastro-...
MaaT Pharma : Information mensuelle relative au nombre total de droits...
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, publie le nombre d'actions composant son capital et le nombre total de droits de vote (articles L. 233-8 II du code de commerce et 223-16 du règlement général de l'AMF) au 31 décembre 2024. Place de cotation : Euronext Paris Code ISIN : FR0012634822 Site web : Date ...
- Hilde Van Boxstael
- Jacob Mekhael
- Lynn Hautekeete
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Thomas Vranken
Onward Medical A long-awaited present underneath the Christmas tree
Right in line with its YE24 guidance, Onward has successfully obtained FDA approval for its non-invasive ARC-EX device. We see the approval as an important inflection point and expect a phased, relatively de-risked launch given the concentrated patient population and Onward's partnership with Lovell. Although home use is not yet included in the label, we believe this could be addressed in 2025 without additional clinical study requirements. We adjust our TP from € 8.7 to € 10.4 and reiterate a B...
ONWARD Medical Receives FDA De Novo Classification and US Market Autho...
ONWARD Medical Receives FDA De Novo Classification and US Market Authorization for World’s First Non-Invasive Spinal Cord Stimulation System for People with Chronic Spinal Cord Injury THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) ARC-EX System is the first and only FDA approved technology shown to improve hand strength and sensation after chronic spinal cord injury ARC-EX System is an FDA Breakthrough Device and 2024 TIME Magazine Best Invention EINDHOVEN, the Netherlands, Dec. 19, 2024 (GLOBE NEWS...
ONWARD® Medical reçoit la classification De Novo de la FDA et l'autori...
ONWARD® Medical reçoit la classification De Novo de la FDA et l'autorisation de mise sur le marché américain pour le premier système non invasif au monde de stimulation de la moelle épinière destiné aux personnes atteintes de lésion chronique de la moelle épinière CE COMMUNIQUÉ DE PRESSE CONTIENT DES INFORMATIONS PRIVÉES AU SENS DE L'ARTICLE (7)(1) DU RÈGLEMENT EUROPÉEN SUR LES ABUS DE MARCHÉ (596/2014) Le système ARC-EX® est la première et unique technologie approuvée par la FDA ayant démontré une amélioration de la force et de la sensation des mains après une lésion chronique de la moell...
- Lynn Hautekeete
- Michiel Declercq
- Thomas Vranken
- Thomas Vranken
UCB Early-stage Parkinson's efforts tremble
UCB's efforts into the neurodegenerative space prove a tough nut to crack, as a Phase 2a study in early Parkinson's disease missed its primary and secondary endpoints. Oral small molecule minzasolmin was designed to address alpha-synuclein misfolding, one of the hallmarks of Parkinson's, but failed to show efficacy in the ORCHESTRA trial. We currently do not yet have strong hypotheses on the reasons of the failure (mechanism of action/drug/trial-related), but minza represented less than 1% of ou...
- Damien Choplain
- Martial Descoutures
- Damien Choplain
- Martial Descoutures
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Wim Lewi
- Jacob Mekhael
MaaT Pharma We're confident going into MaaT013's phase 3 topline in aG...
With recruitment completed for the phase 3 trial of lead program MaaT013 in aGvHD, topline data with GI-ORR is pinned for January 2025. We preview the upcoming readout and expect 15-20% upside if our base case materialises. We update our model to increase our peak sales expectations for MaaT013 in aGvHD to € 170m (from € 100m), which ups our TP to € 16 (from € 14). While this initial program represents a smaller commercial opportunity for MaaT, we see the results for MaaT013 as key to validate t...
ONWARD Medical Ranks in Top 15 Percent Globally for Corporate Sustaina...
ONWARD Medical Ranks in Top 15 Percent Globally for Corporate Sustainability EcoVadis silver medal recognizes Company's environmental and social impact Demonstrates ongoing commitment to integrating sustainable business practices EINDHOVEN, the Netherlands, Dec. 12, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has been awarded a silver medal by EcoVadis, the world’s largest p...
- Guy Sips
- Kristof Samoy
- Michiel Declercq
- Wim Hoste
Local Champions Midcap Conference Book 12.12.2024
This conference book is your guide to our annual Local Champions Mid Cap Conference set to take place on Thursday, 12 December 2024 at our historic building at Grand Place in Brussels. This event offers the possibility to have one-on-one meetings and/or attend small group sessions with the top management and/or IR of the following companies: BARCO | BEKAERT | DECEUNINCK | EKOPAK | EVS | GREENYARD | IBA | JENSEN | ONTEX | RECTICEL | VAN DE VELDE | WHAT'S COOKING? | XFAB
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.