The interesting outcome this month was a rejection of a conditional marketing authorization for pridopidine, an S1R agonist intended for use in Huntington's Disease.
CHMP explained that the drug was rejected for lack of efficacy.
According to an April 2025 narrative overview of its trial results by a physician at rethinkingclinicaltrials.org, this was a Phase 2 platform trial (multiple drug versions tested) with a 3:1 ratio of treated to placebo patients. Per the writeup, "While Pridopidine was safe and well tolerated, there was no overall effect on the primary endpoint. However, potentially meaningful signals were seen suggesting efficacy in secondary endpoints."
The company apparently believed its Phase 2 results in the secondary endpoints were promising enough to justify an MAA under a conditional application, which has now failed.
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