reports
- ING Helpdesk
- Guy Sips
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Hoste
- ING Helpdesk
- Jacob Mekhael
MaaT Pharma To present preclinical data on MaaT034 at AACR
MaaT will present new non-clinical data on MaaT034 (donor independent microbiome therapy) at the American Association for Cancer Research (AACR) conference, taking place on 25-30 April. The results demonstrate MaaT034's potential as a combination therapy to improve responses to checkpoint inhibitors in solid tumours. Being co-cultured means MaaT034 is donor-independent, which offers the scale required for the larger solid tumour market. Initial data from the phase 2 placebo-controlled trial of l...
- Guy Sips
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Onward Medical 2024 was a transformational year, 2025 to scale commerc...
Onward reported its FY24 business update, which underlined a lot of progress yet no major new surprises, and it reaffirms its outlook of main catalysts. Mgmt. confirmed demand is strong, but no commercial outlook was given yet. We look forward to an FDA label expansion for home use in 2025, while we also expect the pivotal Empower BP trial in blood pressure control to kick off. FY24 topline (€ 1.7m) and net result (€ -35.7m) came in line with our expectations, and with a € 60m cash position we b...
ONWARD Medical Reports Full Year 2024 Financial and Operating Results ...
ONWARD Medical Reports Full Year 2024 Financial and Operating Results and Shares 2025 Year-to-Date Highlights Received FDA authorization and recorded first commercial sales of ARC-EX System Secured strategic investment from Ottobock and extended cash runway for two years Gained exclusive rights to premier brain-computer interface technology EINDHOVEN, The Netherlands, April 01, 2025 (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 ...
ONWARD Medical publie ses résultats financiers et opérationnels pour l...
ONWARD Medical publie ses résultats financiers et opérationnels pour l’exercice 2024 et partage ses faits marquants du début de l’année 2025 Obtention de l’autorisation de la FDA et premières ventes commerciales du système ARC-EX Investissement stratégique d’Ottobock et extension de la visibilité financière sur deux ans Obtention de droits exclusifs sur une technologie de pointe d’interface cerveau-machine EINDHOVEN, Pays-Bas, 01 avr. 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext : ONWD), société de technologie médicale développant des thérapies innovantes po...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Sharad Kumar S.P
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
MaaT Pharma FIRST LOOK: FY24 results extend runway with € 13m private ...
MaaT reported FY24 results with the key item being the private placement of € 13m supported by existing shareholders. This extends the company's runway into October 2025 (previously into 2Q25) and provides sufficient funding to reach a number of milestones including MAA submission for MaaT013 to the EMA (June 2025), and enables the company to make progress with its regulatory interactions with the FDA to clarify the route to market in the US. On the pipeline front, we continue to look forward to...
- Thomas Vranken
Onward Medical FIRST LOOK: First-in-human implant of new ARC-IM lumbar...
Onward announced the first-in-human use of its new lumbar (lower back) lead for ARC-IM, that could deliver targeted stimulation to restore lower limb mobility (e.g., standing & walking). We see this as an important clinical milestone, while we expect the company to continue to prioritize the commercial launch of ARC-EX and the start of the pivotal Empower BP trial with ARC-IM for blood pressure control. We reiterate our € 10.4 TP and Buy rating.
- Hilde Van Boxstael
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
ONWARD Medical Announces First-in-Human Use of ARC-IM Lumbar Lead Desi...
ONWARD Medical Announces First-in-Human Use of ARC-IM Lumbar Lead Designed to Restore Standing, Stepping, and Lower Limb Mobility The ARC-IM Lumbar Lead is the second model in the ARC-IM Lead family to be used in a clinical feasibility study The Company is building a portfolio of purpose-designed leads to optimize delivery of ARC-IM Therapy at various locations along the spinal cord to enable restoration of movement and other functions EINDHOVEN, the Netherlands, March 26, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative s...
- 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...
- Guy Sips
- Jacob Mekhael
- Sharad Kumar S.P
ONWARD Medical Schedules Reporting of Full Year 2024 Financial Results...
ONWARD Medical Schedules Reporting of Full Year 2024 Financial Results and Business Update Webcast EINDHOVEN, the Netherlands, March 19, 2025 (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) and other movement disabilities, today announces that it will report Full Year 2024 Financial Results and host a webcast to discuss business highlights. The webcast will be held on April 1, 2025, at 2:00PM CET / 08:00AM E...
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 ...
- 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...
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.