sur MAAT PHARMA (isin : FR0012634822)
MaaT Pharma: unfavorable vote by the CHMP for MaaT013
MaaT Pharma announced that a negative voting trend was observed during the oral hearing of the Committee for Medicinal Products for Human Use (CHMP) regarding the application for conditional marketing authorization of MaaT013 (Xervyteg®) in Europe. This decision follows the meeting of September 14, 2026, and precedes the formal opinion of the CHMP, expected on September 18, 2026.
The main obstacle for MaaT013 appears to be the lack of a randomized controlled trial, a crucial point for the CHMP regarding the assessment of clinical benefits and safety. MaaT Pharma has expressed its disappointment with this negative trend but remains committed to exploring all options to make this treatment available.
The company plans to provide updates after the formal notice is adopted. The implications of this decision will also be studied to determine possible next steps.
R. E.
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