Replies to post #494882 on Anavex Life Sciences Corp (AVXL)

[boi568]

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.

[sumbuysumsell]

So maybe yesterdays action was some whale that had the privilege of an early look at the minutes who wanted to get out for abit (or go short) once they saw no action taken this month for AVXL.

[kund]

EMA rejected another sigm1-receptor based miracle drug. Anavex arrogant buffoon actually believes he can run a tiny trial with just three patients and still get the drug approved. He might be shitting in his pant now—no surprise the banana-obsessed bonny model is posting pictures of bigger bananas, hinting she’s on the hunt for a bigger, wealthier sugar daddy.

[ExtremelyBullishZig]

Why apologize to the bears? Doesn't look like Anavex was recommended for approval.