Immuvera Therapeutics receives EMA Limited Market Authorisation and advances to registration study
Immuvera Therapeutics today announces that the European Medicines Agency (EMA) has granted a Limited Market Authorisation (LMA) for our lead veterinary medicine—an important milestone for animals with high unmet medical need.
Written by
Immuvera
Insight
Sep 26, 2025
1-2 min read
What this means
The LMA pathway enables earlier availability in veterinary limited markets while maintaining rigorous safety and quality standards, including ongoing pharmacovigilance and evidence generation.
Next step: randomized registration study
We will conduct and finalize a randomized clinical study in dogs as quickly as possible to support a subsequent full market approval.
Design & endpoints: The study is structured as a registration (pivotal) trial with median overall survival (mOS) and quality of life (QoL) as key endpoints.
Geographies: Multicentre execution across Spain, Portugal, Italy, and Germany.
Commitment: Speed with scientific rigor, close collaboration with investigators and regulators, and continuous post-authorisation monitoring.
“Securing LMA is a major step for Immuvera—and our commitment now is to deliver the randomized registration study with urgency and rigor so we can progress toward full approval.”
— Jørund Sollid, CEO, Immuvera Therapeutics
