reports
- 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
- 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...
- 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
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...
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...
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Wim Lewi
- Jacob Mekhael
MaaT Pharma FIRST LOOK: DSMB recommends MaaT033 phase 2b continues as ...
MaaT announced that the DSMB (safety board) completed its routine safety assessment of the phase 2b trial (PHOEBUS) of MaaT033 (microbiome therapy, oral capsule) in patients post allo-HSCT, and recommended continuation of the trial without modification. The trial is expected to include the last patient in 2Q26, which means a readout can be expected in 2H27. MaaT033 is next in line after lead product MaaT013 (microbiome therapy, enema formulation), and being an oral capsule means the product coul...
MaaT Pharma annonce le résultat positif du deuxième DSMB pour l'essai ...
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 que le DSMB a complété la seconde évaluation portant sur la sécurité pour l'essai de Phase 2b PHOEBUS, le plus large essai contrôlé randomisé évaluant une thérapie issue du microbiote en oncologie à ce jour, et a recommandé la poursuite de l'essai sans modification. Le D...
MaaT Pharma Announces Positive Second DSMB Review of Ongoing Phase 2b ...
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 that the DSMB completed its second safety assessment of the Phase 2b trial PHOEBUS, the largest randomized controlled trial assessing microbiome therapy in oncology to date, and recommended continuation of the trial without modification. The routine DSMB, which convenes every six months, is composed of 5 i...
- 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...
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 ...
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