LYON, France, June 26, 2026, 14:01 CEST
- Xervyteg was among three drugs to get a negative opinion from EMA’s human medicines committee in June. Six new medicines picked up positive opinions.
- MaaT is seeking a re-examination and a Scientific Advisory Group hearing ahead of the CHMP meeting set for Sept. 14-17.
- MaaT shares changed hands at 2.60 euros on Friday, falling 3.9%. The stock has dropped roughly 46% this year.
MaaT Pharma (EPA:MAAT) plans to ask for a re-examination of Xervyteg after European regulators rejected the drug. The French biotech’s lead asset will face another look in September, a move that could decide both the drug’s future and the company’s balance sheet.
Xervyteg, also known as MaaT013, got a negative opinion from the European Medicines Agency’s CHMP at its meeting from June 22-25. The therapy is a pooled allogeneic faecal microbiota treatment for adult patients with acute graft-versus-host disease, a serious transplant complication.
What stands out for investors isn’t only the rejection but the mix. In June, CHMP put out three negative opinions on new medicines and six positive ones. For 2026 so far, the panel has given 42 positive and six negative opinions on new medicines.
MaaT said CHMP stuck to its concern that it could not attribute the ARES data package effect and safety profile solely to MaaT013, since the data came mainly from a single-arm study and patients got other medicines along with it. MaaT said it will ask for a re-examination with a new rapporteur and co-rapporteur, and also will go to a Scientific Advisory Group in hematology. A second opinion could come about 60 days after the request gets validated, during the Sept. 14-17 CHMP meeting.
MaaT’s case now hinges more on attribution than on response rates. In the ARES trial, 41 out of 66 patients, or 62%, showed a gastrointestinal response at Day 28. All-organ response was seen in 42 of 66, or 64%. One-year overall survival in ARES was 54%. The CHRONOS real-world study, which used third-line best available treatments excluding microbiome therapy, had a 37% gastrointestinal response at Day 28 and 29% 12-month overall survival, according to MaaT.
Florent Malard, hematology professor at Saint-Antoine Hospital and Sorbonne University, said in March that ARES response rates and survival numbers “strongly suggest” there’s a clinical benefit. But the CHMP opinion shows the committee wanted more than just a comparison. MaaT Pharma
The stock was down 3.88% at 2.60 euros in Euronext Paris trade at 07:43 EDT. Shares have fallen 45.95% this year. Market cap sat at about 50.97 million euros.
MaaT reported 18.1 million euros in cash and cash equivalents at March 31, not including a 6 million euro tranche from the European Investment Bank that came in April. The company said in May that the extra funds would extend its cash runway through November 2026. CFO Eric Soyer said MaaT had kept “financial discipline” and pushed its runway into November. Euronext Live
Tight timeline here. If CHMP reviews in September, it fits within the current runway. But a second negative opinion or any delays would push the financing issue right up against the clinical decision.
Chief Executive Hervé Affagard said after CHMP pointed to a negative trend in May that MaaT still “strongly believe[s]” in MaaT013’s registration chance and is “fully committed” to the re-examination. MaaT Pharma
MaaT said Friday its early access program will keep running during the re-examination. The program covers 13 countries and has reached over 300 patients since 2019. First-quarter revenue from the program was 0.8 million euros, with like-for-like MaaT013 revenue rising 19% from a year ago.
