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