Lyon, France, May 20, 2026
MaaT Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a “negative trend” opinion regarding the company’s conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease (aGvHD). The update follows the company’s recent oral explanation meeting with the CHMP ahead of the formal vote expected during the EMA’s June 2026 meeting.
MaaT Pharma stated that, subject to the final CHMP decision in June, it plans to initiate a re-examination procedure, a standard EMA regulatory process that enables a fresh scientific review by a new panel of reviewers. Under EMA guidelines, the CHMP is required to complete the re-examination within 60 calendar days after receiving the company’s formal request.
The company emphasized that it remains confident in the potential of MaaT013 (Xervyteg®) despite the current regulatory setback. According to MaaT Pharma CEO and co-founder Hervé Affagard, the company continues to believe strongly in the therapy’s potential to address the major unmet medical need in patients suffering from acute Graft-versus-Host Disease, particularly those with limited treatment options.
MaaT013 Targets Critical Unmet Need in aGvHD
Acute Graft-versus-Host Disease (aGvHD) is a severe and potentially life-threatening complication that can occur after allogeneic stem cell transplantation, where donor immune cells attack the recipient’s tissues. Patients with steroid-refractory aGvHD face poor survival outcomes and limited therapeutic alternatives, making the condition a major focus area for innovative immunotherapy and microbiome-based treatment development.
MaaT013 (Xervyteg®) is a microbiome ecosystem therapy designed to restore gut microbiome diversity and modulate immune responses in cancer patients. The therapy is based on MaaT Pharma’s proprietary pooling and co-cultivation technologies, which aim to produce standardized, high-diversity microbiome therapeutics.
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The company noted that the challenges raised during the CHMP review are not uncommon for first-in-class microbiome-based therapies, especially those supported primarily by data from a single-arm pivotal study rather than randomized controlled trials. MaaT013 is being reviewed under the EMA’s Conditional Marketing Authorization (CMA) pathway, which is intended to accelerate access to therapies addressing urgent unmet medical needs while confirmatory data continues to be generated after approval.
Clinical Data and Early Access Program Support Application
The regulatory submission for MaaT013 is supported by results from the company’s pivotal ARES study, along with extensive real-world evidence generated through an ongoing Early Access Program (EAP). Since 2019, more than 300 patients across 13 countries have reportedly received MaaT013 treatment through the EAP program.
MaaT Pharma stated that clinical findings supporting MaaT013 have previously been presented at major international medical congresses and published in peer-reviewed scientific journals. The company continues to position the therapy as a potentially important advancement in the field of microbiome-driven immunomodulation in oncology.
Beyond MaaT013, MaaT Pharma is also advancing a broader pipeline of microbiome-based therapies focused on improving outcomes for cancer patients through immune system modulation.
Company Extends Financial Runway Amid Regulatory Review
Alongside the regulatory update, MaaT Pharma confirmed that it is implementing cash management measures designed to extend the company’s financial runway into November 2026, compared with its previous guidance of August 2026. The extended runway is expected to support key regulatory milestones, including the planned EMA re-examination process, while allowing the company to continue development of its broader clinical pipeline.
Despite the negative trend indication from the CHMP, MaaT Pharma stated it remains fully committed to engaging with European regulators and pursuing approval pathways for MaaT013 in Europe.
Source: MaaT Pharma press release
