According to the Complaint, Anavex investigates, manufactures, and markets pharmaceuticals for central nervous system (CNS) disorders.  The Company’s primary product is blarcamesine (Anavex 2-73).  Blarcamesine aims to modify specific genetic pathways associated with some CNS disorders.  Anavex has sponsored several research studies concerning blarcamesine’s suitability to treat various CNS disorders.  One such disorder Anavex has investigated is Rett syndrome, a neurodevelopmental disorder affecting primarily females.

Prior to the start of the Class Period, Anavex sponsored the Avatar Phase II and III (“Avatar”) clinical trials which investigated blarcamesine’s suitability as a treatment for adults with Rett syndrome.  According to the study protocol it posted on “clinicaltrials.gov” (“ClinicalTrials”), an FDA-sponsored Web site which lists pertinent information about pharmaceutical trial research protocols, Anavex intended to use several “Primary Outcome Measures” and “Secondary Outcome Measures” to evaluate Avatar’s efficacy and overall clinical benefit.  Contrary to the protocol described on ClinicalTrials, when Anavex later reported its trial results, the Company revealed that it used alternative measures to assess the drug’s success.

Notwithstanding the backlash it received from the market and the substantial market capitalization losses, Anavex would proceed to pull the same sleight of hand with its “Excellence” Phase II/Phase III study, which investigated blarcamesine as treatment for pediatric Rett syndrome patients. On January 2, 2024, the Company announced the Excellence study results. The Company used the “MMRM” method – a statistical method not used in the Avatar study – to analyze the data. The Excellence study failed to achieve statistical significance on all but one measure.

On this news, Anavex’s stock price declined by $3.29 per share, or over 35%, to close at $6.05 per share on January 2, 2024.

If you wish to serve as lead plaintiff, you must move the Court no later than May 13, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.

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