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On December 2, 2022, AVXL announced positive topline results from its Phase 2b/3 ANAVEX®2-73-AD-004 clinical trial of oral ANAVEX®2-73 (blarcamesine) for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD). ANAVEX®2-73 met the primary endpoints ADAS-Cog1 and ADCS-ADL2 and key secondary endpoint CDR-SB3 with statistically significant results. An analyst questioned the Company’s claim noting “there are several key factors that point us to believe the data is provocative, but not yet compelling, given the choice of statistical analyses and other trial design/conduct ‘complexifiers’.” Additionally, a biotech journalist commented on AVXL’s findings stating “[w]hat sets Anavex apart from all the other biotechs on my radar screen is its habit of shifting the goalposts on clinical trials…Anavex announced “positive” outcomes from studies of its drug called blarcamesine — except the results were derived from efficacy endpoints that were not part of the original study designs.”
Following this news, AVXL’s stock price fell by $2.47 per share, or approximately 20% to close at $9.58.
Further on January 3, 2024, AVXL announced that results from its Phase 2/3 EXCELLENCE clinical trial for its candidate ANAVEX®2-73 in pediatric patients with Rett syndrome failed to show statistical significance towards its primary endpoints. Biotech analysts commented that “the negative study outcome was never in doubt…Anavex is a serial dissembler of clinical trial results.”
Following this news, AVXL’s stock price fell by $3.26 per share, or approximately 35%.