KBC Securities - MAAT PHARMA SA (MAAT) MaaT Pharma MaaT013 PIP approval clears path for MAA submission in June 2025

Report

KBC Securities

Jacob Mekhael

MaaT Pharma MaaT013 PIP approval clears path for MAA submission in June 2025

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 means the product could be approved by late 2026. We reiterate our € 18 TP and BUY rating.

12/03/2025 1 EN

Underlying

MAAT PHARMA SA

See profile

FR0012634822 Euronext Paris France

Provider

KBC Securities

We are a financial services provider for several types of professional clients, each with distinct needs.

See profile

Analysts

Jacob Mekhael

Other Reports on these Companies

BusinessWire

MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013

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...

20h / 54m 20h / 54m 1 EN

BusinessWire

MaaT Pharma reçoit un avis positif du Comité Pédiatrique de l'EMA pour le plan d'investigation pédiatrique de MaaT013

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...

20h / 54m 20h / 54m 1 FR

Zealand Pharma FIRST LOOK: Roche petrelintide partnership conference call feedback

Zealand hosted a conference call to discuss the co-development and co-commercialisation partnership with Roche for petrelintide announced this morning. Our key learning was that the 50/50 profit share remains in place even if Zealand decides to be less than 50% involved in the commercial roll out, which further points to the attractiveness of the terms the company has been able to secure. We summarise the key takeaways from the conference call.

45m 45m 1 EN

Lynn Hautekeete

Lynn Hautekeete

Basic-Fit Strategy shift: giving up growth for FCF

Basic-Fit reports FY24 results below our expectations. The underlying EBITDA less rent came in at EUR 312.9m vs EUR 319.7m KBCSe. The difference comes from higher employee expenses driven by more 24/7 openings in France in 2H24. On a net results basis the expectations were not met due to 10% higher financing costs. Both the expansion and maintenance capex per club are higher than initially guided. The higher maintenance capex impacted the FCF per share at EUR 2.36 vs EUR 2.60-2.95 guided (EUR 2.64 KBCSe). For FY25/26 Basic-Fit comes with a strategy shift to open less clubs. This saves them app...

6h 6h 1 EN

Sign-up for free to access full reports immediately

Email Address*

Choose Password* ( 6 or more characters )

Due to regulatory restrictions regarding the distribution of financial research, this report is restricted to a specific region or investor type. Get access to exclusive reports by answering the questions below.

Select your country*

Get financial insights straight to your inbox

By clicking "register" you accept the Terms and Conditions & Privacy Policy

Already on ResearchPool?

Almost there...

Are you a professional investor?

Select your country

REGISTER

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

In order to access this report please create an account.

LOGIN

MaaT Pharma MaaT013 PIP approval clears path for MAA submission in June 2025

We are a financial services provider for several types of professional clients, each with distinct needs.

MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013

MaaT Pharma reçoit un avis positif du Comité Pédiatrique de l'EMA pour le plan d'investigation pédiatrique de MaaT013

Zealand Pharma FIRST LOOK: Roche petrelintide partnership conference call feedback

Basic-Fit Strategy shift: giving up growth for FCF

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

Sign-up for free to access full reports immediately

ResearchPool Subscriptions

Get the most out of your insights

Why subscribe?

How to subscribe

ResearchPool Subscriptions

This report is only available to subscribers

Why subscribe?

How to subscribe