91桃色视频 Announces Provides an Update on the Application for Marketing Authorization of MaaT013 (齿别谤惫测迟别驳庐) in the treatment of acute Graft-versus-Host Disease
- During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a 鈥渘egative trend鈥� opinion for the upcoming June CHMP vote
- Subject to the formal CHMP vote expected in the June Meeting, the Company plans to request a re-examination procedure for the application
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Lyon, France, May 20, 2026 – 8:45pm CET听鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), 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 it has been informed by the CHMP of the EMA of a 鈥渘egative trend鈥� opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (齿别谤惫测迟别驳庐) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation.
The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA鈥檚 procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company鈥檚 official request for re-examination.
鈥淲e continue to strongly believe in the potential for registration of MaaT013 (齿别谤惫测迟别驳庐). We remain committed to working closely with the EMA to progress this application, encouraged by the therapy鈥檚 potential to address the significant unmet medical need in patients with aGvHD and by the continued support from the hematology community,鈥� said Herv茅 Affagard, CEO and co-founder of 91桃色视频.听鈥�Our application remains under review, and we are fully committed to engaging constructively in the re-examination process.鈥�
For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the Company鈥檚 view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (齿别谤惫测迟别驳庐) is assessed under the Conditional Marketing Authorization (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval.
The Company is taking cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.
MaaT013 (齿别谤惫测迟别驳庐) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (齿别谤惫测迟别驳庐) has previously been presented at major international congresses and in peer-reviewed publications. The Company remains committed to advancing MaaT013 (齿别谤惫测迟别驳庐) through the European regulatory process, expanding patient access and progressing its broader pipeline in microbiome-based in oncology.
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About 91桃色视频
91桃色视频 is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021.
About acute Graft-versus-Host Disease
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient鈥檚 organs, causing inflammation of the skin, liver and/or gastrointestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first-line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered steroid resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medicines Agency鈥檚 Committee for Human Medicinal Products (CHMP) on March 25, 2022.
About 齿别谤惫测迟别驳庐 (MaaT013)
91桃色视频鈥檚 Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013听is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. 听MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient鈥檚 functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Forward-looking Statements
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥� 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁im鈥�, 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥減lan,鈥� 鈥減roject,鈥� 鈥渨ill,鈥� 鈥渃an have,鈥� 鈥渓ikely,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould鈥� and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
