Xervyteg (MaaT013) / MaaT Pharma, Clinigen - LARVOL DELTA

After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Xervyteg. (European Medicines Agency) - "The medicine was intended for the treatment of acute graft-versus-host disease (aGvHD), when donor cells attack the body shortly after a transplant.The Agency issued its opinion after a re-examination on 17 September 2026. The Agency had issued its initial opinion on 25 June 2026. The company that applied for authorisation of Xervyteg is MaaT Pharma."

CHMP • Acute Graft versus Host Disease

MaaT Pharma Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg) Following Re-Examination for its Conditional Marketing Authorization Application in Europe (Businesswire) - "Based on the feedback received post Oral Explanation, the CHMP maintained its view that the available clinical data package, primarily in the absence of a randomized control trial, does not allow sufficient characterization of the benefit/risk of MaaT013 (Xervyteg). The Company will provide additional details following the formal CHMP opinion, which is expected to be communicated on September 18, 2026. The Company will assess the implications of the decision and evaluate all available options and will provide an update to the market as appropriate."

CHMP • Acute Graft versus Host Disease

MaaT Pharma…announced that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy. (Businesswire) - "This is supported by data from the ARES study, as well as data from the CHRONOS study (Clausen et al., 2026) and real-world evidence from its Early Access Program, active in 13 countries, with more than 300 patients treated since 2019."

CHMP • Acute Graft versus Host Disease • Immunology

MaaT Pharma Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg) in the treatment of acute Graft-versus-Host Disease (Businesswire) - "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...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’s procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company’s official request for re-examination....The MaaT013 (Xervyteg) 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..."

CHMP • EMA filing • Acute Graft versus Host Disease

MPOH14: A medical research to evaluate if MaaT013 is safe and helps children and adolescent with GI-aGvHD after failed two prior therapies. (clinicaltrialsregister.eu) - P1/2 | N=6 | Not yet recruiting | Sponsor: MaaT PHARMA

New P1/2 trial • Acute Graft versus Host Disease • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Pediatrics

MaaT013 pooled fecal microbiotherapy improves gastrointestinal physiology and controls inflammation which delays GvHD in a proof-of-concept humanized mouse study (AACR 2026) - "Altogether, these results support the potential of MaaT013 to mitigate aGvHD through restoration of microbial diversity, gut barrier integrity, and immune homeostasis, leading to control of inflammation."

Preclinical • Oncology • IL10

MaaT Pharma Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal (Businesswire) - "Key findings from CHRONOS study include: GI-overall response rate (ORR) at Day 28 was 37% with 22% GI-complete response (n=13), 10% GI-very good partial response (n=6), and 5% GI-partial response (n=3), and all-organ ORR at Day 28 was 36%; Response rates declined by Day 56 with a GI-ORR of 22% and all-organ ORR of 20%, suggesting rapid loss of response; 12‑month overall survival: 29%; Median overall survival: 86 days....MaaT013 (Xervyteg) Marketing Authorization application is currently under regulatory review by the EMA, with feedback anticipated mid-2026, based on EMA’s standard timelines."

EMA approval • Real-world evidence • Acute Graft versus Host Disease

MAAT013 FOR RUXOLITINIB-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE WITH GASTROINTESTINAL INVOLVEMENT: FINAL RESULTS FROM THE ARES PHASE III TRIAL (EBMT 2026) - P3 | "Final ARES results demonstrate that MaaT013 induces frequent and deep responses translating into prolonged survival and acceptable safety profile in subjects with aGvHD who previously failed both systemic steroids and ruxolitinib, a population characterized by poor clinical outcomes with limited therapeutic options. These positive results support MaaT013 as the first microbiome-based therapy for the treatment of refractory aGvHD."

Clinical • P3 data • Acute Graft versus Host Disease • Gastrointestinal Disorder • Graft versus Host Disease • Immunology

THRASSA, A MULTICENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY AND EFFICACY OF MAAT013 IN RUXOLITINIB-REFRACTORY OR INTOLERANT PAEDIATRIC/ADOLESCENT PARTICIPANTS WITH GASTROINTESTINAL ACUTE GRAFT-VERSUS-HOST DISEASE (EBMT 2026) - P1/2, P3 | "After a 2-day oral vancomycin pre-treatment, patients will receive 3 doses of MaaT013 over 10 days.The primary endpoint, safety and tolerability, includes incidence of (Serious) adverse events (AEs), assessment of all safety parameters (clinical, laboratory) until M6 and, from M6 to M12 incidence of SAEs and AE of special interest. THRASSA"

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics

Clinical Case Highlights: MaaT013 in Real World Practice (EBMT 2026) - "Sponsored by Clinigen."

Clinical • Real-world • Real-world evidence • Graft versus Host Disease

Clinical Evidence Supporting MaaT013 in aGvHD (EBMT 2026) - "Sponsored by Clinigen."

Clinical • Graft versus Host Disease

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 (Businesswire) - "GI-ORR at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients). All-organ ORR at Day 28 occurred in 42/66 patients (64%) and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients). GI-ORR at Day 56 was maintained at 47% (31/ 66 patients) and prevalently consisted of CR (35%, 23/66 patients)....A durable response was observed, with an estimated cumulative incidence of loss of response at 12 months of 20% (95% CI: 9 to 33) for GI. For all-organs, the estimated cumulative incidence of loss of response at 6 months was 26% (95% CI: 14 to 40). Overall survival (OS) at 12 months was 54%."

P3 data • Acute Graft versus Host Disease

MaaT013 is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision expected mid-2026… (Businesswire)

EMA approval • Acute Graft versus Host Disease

MaaT Pharma to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management (Yahoo Finance) - "Oral presentation during Presidential Plenary Session to feature the final results of the ARES pivotal Phase 3 trial evaluating MaaT013 in acute Graft‑versus‑Host Disease (aGvHD) with gastrointestinal involvement...In addition, MaaT Pharma will present three poster communications, featuring: Key results from CHRONOS, a multicenter retrospective cohort study describing real‑world outcomes in third‑line acute gastrointestinal GvHD, and The study designs of two clinical trials (PHOEBUS and THRASSA- pediatric study announced in March 2025) advancing the Company’s therapeutic pipeline."

Clinical data • Trial status • Acute Graft versus Host Disease

This trial, sponsored by Gustave Roussy, is part of MaaT Pharma’s exploratory strategy launched in 2022, which also includes the PICASSO trial, a Phase 2a randomized controlled trial sponsored by AP-HP in Paris evaluating Xervyteg (MaaT013) in combination with ICIs, ipilimumab (Yervoy) and nivolumab (Opdivo) for patients with metastatic melanoma. (Businesswire) - "The Company has been informed by PICASSO's academic sponsor that topline results could not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026."

P2a data • Melanoma

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 (Businesswire) - "GI-ORR at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients); All-organ ORR at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients); GI-ORR at Day 56 was maintained at 47% (31/ 66 patients) and prevalently consisted of CR (35%, 23/66 patients)...Overall survival (OS) at 12 months was 54% (median survival not reached)...The OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond: 68% vs 28% respectively (p <0.0001), indicating a strong association between early GI response and improved survival in refractory GI-aGvHD."

P3 data • Acute Graft versus Host Disease

MaaT013 for ruxolitinib-refractory acute graft-versus-host disease with gastrointestinal involvement: Results from the ARES phase III trial (ASH 2025) - P3 | "The treatment period included apreparatory course of 2-day oral vancomycin [250 mg 4 times a day (D)] followed by rectal administrationof 3 MaaT013 doses (on D1, D5 and D10). Out of 26 fatal AEs, one was deemed related toMaaT013.ConclusionResults from the ARES study demonstrate that MaaT013 induces frequent and deep responsestranslating into prolonged survival and an acceptable safety profile in patients with aGvHD whopreviously failed both systemic steroids and ruxolitinib, a population characterized by poor clinicaloutcomes with limited therapeutic options. These positive primary analysis results support MaaT013 asthe first microbiome-based therapy for the treatment of refractory aGvHD."

P3 data • Acute Graft versus Host Disease • Gastrointestinal Disorder • Graft versus Host Disease • Immunology

A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating the Efficacy and Safety of MaaT033, an Oral, Pooled Microbiome Ecosystem Therapy in Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: The Phoebus Trial (ASH 2023) - P2 | "Exclusion criteria comprise non-myeloablative conditioning regimen, conventional myeloablative conditioning regimen, in-vitro T-cell depletion, alloHCT with cord blood cells, alloHCT from an unrelated donor with ≥ 3/10 HLA-mismatches, use of alemtuzumab, vedolizumab or abatacept for GvHD prophylaxis, history of chronic digestive disease...Exploratory endpoints will describe the impact of MaaT013 on immune recovery, the nutritional status of the patients, and resource utilization...The study is approved in France and Germany; expansion to other countries is planned for 2024. Study start is expected in September 2023."

Clinical • P2b data • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Transplantation

Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease : Results from Early Access Program in Europe (ASH 2024) - P3 | "Interestingly, the response to MaaT013 correlates with increased OS, suggesting a strong favorable benefit-risk profile for MaaT013. A Phase 3 trial is currently ongoing to confirm these results in ruxolitinib-refractory patients (NCT04769895)."

Acute Graft versus Host Disease • Acute Respiratory Distress Syndrome • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Septic Shock

Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease : Results from Early Access Program in Europe (ASH 2023) - P3 | "Interestingly, response of GI-aGvHD correlates with increased overall survival, suggesting a strong favorable benefit-risk profile for MaaT013. A Phase 3 trial is currently ongoing to confirm these results in ruxolitinib-refractory patients (NCT04769895)."

Acute Graft versus Host Disease • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Osteoarthritis • Pediatrics • Rheumatology • Septic Shock

MaaT Pharma Announces Positive Phase 3 Results Evaluating Xervyteg (MaaT013) in Acute Graft-versus-Host Disease Selected for Oral Presentation at ASH Congress 2025 (Businesswire) - "Xervyteg (MaaT013) is currently under regulatory review by the European Medicines Agency (EMA), with a decision anticipated in the second half of 2026...Final results, including 1-year overall survival, are expected by the end of 2025...Efficacy data to be presented at the ASH annual meeting is summarized below...(up to the data cut-off of November 11, 2024): GI-Overall Response Rate at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (25/66 patients, 38%) and very good partial response (VGPR) (13/66 patients, 20%); Overall Response Rate (all organs) at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (24/66 patients, 36%) and VGPR (12/66 patients, 18%)....The estimated OS was 54% with a median follow-up of 140.5 days (median survival not reached)."

EMA approval • P3 data • Acute Graft versus Host Disease

MaaT Pharma Launches a Capital Increase of Approximately €9 Million (Businesswire) - "Preparation of the commercialization of Xervyteg and related regulatory activities in Europe during the second half of 2026, in collaboration with our commercial partner, contingent upon Xervyteg approval (potential marketing authorization (MA) could be delivered around mid-2026). Advancement of MaaT033 clinical development in Europe, currently being evaluated in an ongoing Phase 2b trial, designed to be pivotal, aimed at improving survival in patients undergoing allogeneic hematopoietic stem cell transplantation."

Financing • Acute Graft versus Host Disease • Transplantation

MaaT Pharma Reports Financial Results for the Third Quarter 2025… (Businesswire) - "MaaT Pharma reported revenues from France from its Early Access Program of EUR 1.0 million for the quarter ended September 30, 2025, a 56% increase over the third quarter of 2024. Total revenues for the first nine months of 2025 amounted to EUR 3.4 million compared with EUR 2.3 million for the same period of 2024, a year-over-year increase of 45%1, reflecting the continued demand from the medical community for MaaT Pharma’s drug candidate Xervyteg(MaaT013)."

Commercial • Acute Graft versus Host Disease

Acute Graft-versus-Host Disease (aGvHD) – Xervyteg (MaaT013) (MaaT Pharma Press Release) - "Final results from the pivotal ARES study, including 12-month overall survival data, are expected before the end of 2025 and will be incorporated into the filing dossier. Data are also being submitted in a peer reviewed journal and upcoming scientific congress."

P3 data • Acute Graft versus Host Disease

Xervyteg – Exploratory trials using the MET-N platform (donor derived conducted as Investigator-Sponsored Trials (ISTs) to inform further developments (MaaT Pharma Press Release) - "In March 2024, the Company completed patient recruitment for the Phase 2a randomized clinical trial (NCT04988841)...evaluating Xervyteg in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo), in metastatic melanoma patients....Data readout is expected in H2 2025 as previously announced."

P2a data • Melanoma