AVXL News & Events

Anavex provided a regulatory update. Following the withdrawal of the application for the marketing authorization of blarcamesine in the EU, Anavex will continue to gather additional data and conduct further analyses to advance the development program in early Alzheimer's disease. The dialogue continues with the EMA to address the points raised by the Committee for Medicinal Products for Human Use. As part of the company's ongoing interactions with the FDA, Anavex has submitted additional data to the regulatory agency with the objective of reaching alignment on the Alzheimer's disease development program for blarcamesine in the U.S. Anavex is also advancing regulatory engagement with EU authorities for blarcamesine in Parkinson's disease and rare neurological conditions, including Rett syndrome, underscoring the breadth of the Company's clinical development portfolio. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

Stock futures are moving higher this morning. Markets are shifting toward a more conditional relief trade, but energy prices are still dictating direction. The move is tied directly to a sharp pullback in crude oil, which dropped more than 4%-5% overnight on renewed hopes for a potential ceasefire framework between the U.S. and Iran. After several sessions where rising energy prices pressured equities and pushed yields higher, the reversal is easing inflation expectations at the margin. As a result, markets are beginning to reprice the path of interest rates slightly lower, which is providing near-term support for equities and risk assets.However, the improvement in sentiment is based on tentative headlines, not confirmed changes in supply dynamics or a finalized agreement. Iran has pushed back on reports of negotiations, and oil has already shown a tendency to rebound quickly when optimism fades. Rising Treasury yields and ongoing geopolitical uncertainty continue to cap upside, particularly for rate-sensitive sectors like technology.In pre-market trading, S&P 500 futures rose 0.67%, Nasdaq futures rose 0.83% and Dow futures rose 0.68%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Armup 10% after reporting the company expects its own chips business to generate about $15B in annual sales in five years.Terns Pharmaceuticalsup 5% after entering into a definitive agreement under which Merck, through a subsidiary, will acquire Terns for $53.00 per share in cashSturm Rugerup 3% after Beretta Holding announced plans to launch a tender offer for up to 20.05% of Sturm Ruger shares at $44.80 per shareHIGHER AFTER REPORT OF ACCELERATED SPACEX IPO TIMELINE -EchoStarup 5%Rocket Labup 3%FireFly Aerospaceup 3%AST SpaceMobileup 2%Planet Labsup 2%UP AFTER EARNINGS -Brazeup 27%Chewyup 10%DOWN AFTER EARNINGS -KB Homedown 3%PDD Holdingsdown 2%Winnebagoup 1%LOWER -Anavexdown 32% after withdrawing its application for the marketing authorization of blarcamesine in the EU as an add-on therapy for the treatment of early Alzheimer's disease in adults, which had been under review by the European Medicines AgencyOn Holdingdown 4% after reporting Martin Hoffmann will step down as CEO

Anavex announced that it has withdrawn its application for the marketing authorization of blarcamesine in the EU as an add-on therapy for the treatment of early Alzheimer's disease in adults, which had been under review by the European Medicines Agency, or EMA. The decision to withdraw the application follows feedback from the EMA's Committee for Medicinal Products for Human Use, or CHMP, indicating that it would not be in a position to issue a positive opinion for the application at this time. The company remains committed to the ongoing clinical development of blarcamesine and to advancing potential therapeutic options addressing the significant unmet medical needs of patients living with early Alzheimer's disease, also motivated by the strong support received by Alzheimer's disease patients and organizations, including Alzheimer Europe. Anavex had submitted the application following encouragement by the SME Office of the EMA in October 2023 when the EMA representatives encouraged Anavex "to immediately begin preparing" for the application and that the "next step for Anavex in terms of interactions with EMA would be to apply for a marketing authorization application." Anavex now has to take note of the differing assessment of the CHMP at the EMA and will consider the constructive feedback received from the CHMP and focus on gathering additional data and conducting further analyses to address the points raised by the CHMP.

Anavex announced new data of blarcamesine was presented at the AD/PD 2026 Conference, drawing from the ANAVEX2-73-AD-004 Phase IIb/III clinical program and its long-term open-label extension, ANAVEX2-73-AD-EP-004. Data from the ANAVEX2-73-AD-004 study also show that patients with wild-type SIGMAR1 and COL24A1 genes, the ABCLEAR32 population, may experience substantially greater clinical and structural benefit from blarcamesine. This reinforces Anavex's precision medicine strategy, leveraging genomic and biomarker-based indicators to optimize therapeutic efficacy. A dedicated analysis of MRI biomarkers demonstrated a highly consistent correlation between slowing of atrophy and improvements across primary and secondary clinical endpoints, including: cognition, activities of daily living, global clinical cognitive and functional outcome. In the genetically defined ABCLEAR32 precision medicine population, the correlation strength improved markedly, with R increasing by 78% for ADAS-Cog13-firmly within the "very suggestive" range for clinical relevance.