Why Clinical Stage Biopharmaceutical Company Anavex Shares Are Tanking Today

Anavex Life Sciences Corp. AVXL shares are trading lower in the premarket session on Tuesday after the company provided an update on Rett Syndrome program.

The company reported topline results from the randomized, double-blind, placebo-controlled, Phase 2/3 EXCELLENCE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 30 mg ANAVEX 2-73 in 92 pediatric patients. The patients were aged between 5 and 17 years.

Rett syndrome is a rare, non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child's life: their ability to speak, walk, eat, and even breathe easily.

Participants were randomized 2:1 (ANAVEX 2-73 [62 patients] to placebo [30 patients]) for 12 weeks, followed by a week 16 safety visit.

After 12 weeks, the study showed improvement on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire (RSBQ). 

The other co-primary endpoint, the Clinical Global Impression – Improvement scale (CGI-I), which represents a less granular assessment by the site investigators using a seven-point scoring, was not met.

A preliminary review of the safety results indicates no new safety signals in the EXCELLENCE study, reinforcing the favorable and manageable safety profile observed with ANAVEX 2-73 to date.

In addition to Rett syndrome, Anavex is evaluating ANAVEX 2-73 in other neurodevelopmental disorders, including Fragile X syndrome, and in neurodegenerative disorders like Parkinson's disease.

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Price Action: AVXL shares are trading lower by 35.1% to $6.04 premarket on the last check Tuesday.