Drugs / MaaT013
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Xervyteg® | acute graft versus host disease | 2026-09-18 | “CHMP of the EMA has maintained its negative opinion on the CMA application for MaaT013” maatpharma.com ↗ |
| Refused (EMA) | EU (EMA) | Xervyteg® | acute graft versus host disease | 2026-06-26 | “CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013” maatpharma.com ↗ |
| Filed | EU (EMA) | Xervyteg | acute graft versus host disease | 2025-06-02 | “MaaT013, which is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025.” maatpharma.com ↗ “today announced the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate MaaT013” maatpharma.com ↗ “CHRONOS results have been included in the MaaT013 (Xervyteg ® ) Marketing Authorization Application filed with the European Medicines Agency (EMA)” maatpharma.com ↗ “In June 2025 , the Company announced the submission of a MAA to the EMA for MaaT013” maatpharma.com ↗ |
| Clinical hold | US (FDA) | — | acute graft versus host disease | 2022-08-10 | “It indicates that the Agency maintains the clinical hold on MaaT013 in the U.S.” maatpharma.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04988841 | Jan 2022 → Aug 2024 | melanoma | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT03359980 | Aug 2018 → Feb 2020 | — | MaaT Pharma | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04769895 | Mar 2022 → Nov 2024 overdue | acute graft versus host disease | MaaT Pharma | Active not recruiting | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04768907 | — | acute graft versus host disease | MaaT Pharma | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | MaaT Pharma | Regulatory MaaT Pharma Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination maatpharma.com ↗
MaaT Pharma Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination |
| 2026-09-15 | MaaT Pharma | Regulatory MaaT Pharma Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe maatpharma.com ↗
MaaT Pharma was informed of a negative trend during the Committee for Medicinal Products for Human Use (CHMP)’s Oral Explanation meeting which took place on September 14, 2026 |
| 2026-06-26 | MaaT Pharma | Regulatory MaaT Pharma Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease maatpharma.com ↗
MaaT Pharma Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease |
| 2026-05-20 | MaaT Pharma | Regulatory MaaT Pharma Announces Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease maatpharma.com ↗
During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a “negative trend” opinion for the upcoming June CHMP vote |
| 2026-03-23 | MaaT Pharma | Results MaaT Pharma Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation maatpharma.com ↗
MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Florent Malard, MD, PhD, hematology professor at Saint‑Antoine Hospital and Sorbonne University, presented the final results from the Phase 3 ARES single‑arm pivotal trial evaluating MaaT013 in acute Graft‑versus‑Host Disease (aGvHD). |
| 2025-12-08 | MaaT Pharma | Results MaaT Pharma Presents Pivotal ARES Phase 3 Results for MaaT013 (Xervyteg®) in Acute GvHD at ASH 2025 Annual Congress and Announces 54% 1-Year Overall Survival maatpharma.com ↗
In addition, the Company announced new data from the pivotal ARES trial including a 1-year overall survival rate of 54%, confirming the global clinical benefit of MaaT013 (Xervyteg®). |
| 2025-11-03 | MaaT Pharma | Results MaaT Pharma Announces Positive Phase 3 Results Evaluating Xervyteg® (MaaT013) in Acute Graft-versus-Host Disease Selected for Oral Presentation at ASH Congress 2025 maatpharma.com ↗
Results highlight strong efficacy and indicate a favorable safety profile for Xervyteg® (MaaT013), reinforcing its potential to become the first third-line treatment for patients with gastrointestinal aGvHD unresponsive to current therapies. |
| 2025-06-13 | MaaT Pharma | Results MaaT Pharma Presents Updated Positive Data in Early Access Program for Xervyteg® at the EHA Congress Validating High Efficacy Observed in Pivotal ARES Study in Acute Graft-versus-Host Disease maatpharma.com ↗ |
| 2025-06-02 | MaaT Pharma | Regulatory MaaT Pharma Advances Toward Commercialization And Submits Marketing Authorization Application to the European Medicines Agency (EMA) for Xervyteg® (MaaT013) in Acute Graft-versus-Host Disease maatpharma.com ↗
MaaT Pharma submitted today a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its product candidate MaaT013, under the registered brand name of Xervyteg ® . |
| 2025-05-14 | MaaT Pharma | Results MaaT Pharma To Present Updated Data for MaaT013 in Early Access Program at the European Hematology Association (EHA) Annual Congress maatpharma.com ↗
These updated EAP results for 173 patients, to be presented at EHA Congress, are consistent with the positive topline results of the Phase 3 trial announced in January 2025 |
| 2025-03-18 | MaaT Pharma | Results MaaT Pharma Announces Positive Outcomes from Final DSMB Meeting for Pivotal Phase 3 Clinical Trial Evaluating MaaT013 in Acute Graft-versus-Host Disease maatpharma.com ↗
The Independent Data Safety and Monitoring Board (DSMB) confirmed the remarkable efficacy results and a positive benefit/risk profile of MaaT013 in this patient population |
| 2025-03-11 | MaaT Pharma | Regulatory MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013 maatpharma.com ↗
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). |
| 2025-01-08 | MaaT Pharma | Results MaaT Pharma Announces Positive Topline Results from the Pivotal Phase 3 ARES Study Evaluating MaaT013 in acute Graft-versus-Host Disease maatpharma.com ↗
The study met its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrates the unprecedented efficacy of MaaT013 as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD). |
| 2024-12-10 | MaaT Pharma | Results MaaT Pharma Presented Positive Updated Data on MaaT013 in the Early Access Program at ASH 2024 Annual Meeting maatpharma.com ↗
Sustained High Response Rates at Day 28: Gastrointestinal Overall Response Rate (GI-ORR) was 51% and Overall Response Rate (ORR) for all organs was 49%. |
| 2024-11-07 | MaaT Pharma | Results MaaT Pharma to Present Updates from Early Access Program at the 2024 ASH Annual Meeting Demonstrating Prolonged Long-Term Survival in Patients Receiving MaaT013 in aGvHD maatpharma.com ↗
Long-term follow-up shows that the observed high response rates translate into a prolonged survival at 2 years. |
| 2024-04-15 | MaaT Pharma | Results MaaT Pharma Presents Positive 18-month Data for MaaT013 Showing a Clear Overall Survival Advantage in aGvHD from the Early Access Program at the 2024 EBMT Event maatpharma.com ↗
Positive efficacy and safety results in 140 patients treated with MaaT013 in acute graft-versus-host disease (aGvHD) as part of the MaaT Pharma Early Access Program (EAP). |
| 2023-12-11 | MaaT Pharma | Results MaaT Pharma Presents Positive Results with Lead Product MaaT013 and Provides Insights on Ongoing Phase 2b Trial with MaaT033 at ASH 2023 maatpharma.com ↗
Gastrointestinal overall response rate (GI-ORR) of 53% observed at day 28 positively and significantly impacted overall survival (OS) in responder patients |
| 2023-10-26 | MaaT Pharma | Results MaaT Pharma Announces Positive Outcome Following DSMB Review Reinforcing Confidence in Phase 3 On-Going Trial in Acute Graft-versus-Host Disease with MaaT013 maatpharma.com ↗
The DSMB concluded on a positive benefit/risk ratio based on a good safety profile and positive preliminary efficacy results with an Overall Response Rate higher than pre-defined protocol assumptions. |
| 2023-07-26 | MaaT Pharma | Results MaaT Pharma Announces Publication of Results in eClinicalMedicine Journal Highlighting Clinical Benefit of MaaT013 in aGvHD maatpharma.com ↗ |
| 2023-04-24 | MaaT Pharma | Regulatory MaaT Pharma Announces U.S. FDA Lifts Clinical Hold on Phase 3 Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease maatpharma.com ↗
We are grateful for the FDA’s continued engagement and are very pleased with the lift of the hold on MaaT013’s IND application. |
| 2023-02-03 | MaaT Pharma | Regulatory MaaT Pharma Receives U.S. FDA Response Outlining Path Forward for Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease and Reports Cash and Revenues for Fourth Quarter 2022 maatpharma.com ↗
The FDA letter indicates that the Agency agrees to a defined list of conditions that could enable clinical evaluation of MaaT013 in the U.S. |
| 2022-12-10 | MaaT Pharma | Results MaaT Pharma Presents Compelling Consolidated MaaT013 Clinical Data at the 64th ASH Annual Meeting maatpharma.com ↗
A 65% ORR was observed in 31 patients treated with MaaT013 as 3rd-line therapy after failure to 2nd-line ruxolitinib treatment; 12-month overall survival in this group responding to MaaT013 treatment was 74%; |
| 2022-08-10 | MaaT Pharma | Regulatory MaaT Pharma Announces Update on U.S. FDA Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease maatpharma.com ↗
It indicates that the Agency maintains the clinical hold on MaaT013 in the U.S. and details the FDA’s position on the clinical trial. |
All press releases naming this drug 30 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MaaT013 | “the first-in-human use of the pooled allogeneic faecal microbiota, MaaT013, for the treatment of steroid-refractory GI-aGvHD” PMID 37654670 ↗ Jul 2023 |
| Action | Restore | “a microbiome restoration biotherapeutic” NCT04988841 ↗ |
| Modality | Other / unclassified | “MaaT013 involved pooling faecal matter from 3 to 8 screened donors then transplanting the pooled batches into patients” PMID 37654670 ↗ Jul 2023 |
| Route | Rectal | “MaaT013 is administered as an enema.” NCT04769895 ↗ |