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Cassava Sciences Announces Positive End-of-Phase 2 Meeting with FDA and Outlines Pivotal Phase 3 Program for Simufilam in Alzheimer s Disease

Published: Feb 22, 2021 AUSTIN, Texas, Feb. 22, 2021 (GLOBE NEWSWIRE) Cassava Sciences Inc., (Nasdaq: SAVA), a biotechnology company developing product candidates for Alzheimer’s disease, today announced the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Official EOP2 meeting minutes indicate FDA and Cassava Sciences agree on key elements of a pivotal Phase 3 clinical program in support of a New Drug Application (NDA) filing for simufilam in Alzheimer’s disease. Agreements reached during the EOP2 meeting show a clear path forward for advancing simufilam into Phase 3 studies in the second half of 2021.

Biohaven Provides Update On Phase 2/3 Trial And Alzheimer s Disease Program

Lilly s Donanemab Slows Clinical Decline of Alzheimer s Disease in Positive Phase 2 Trial

Lilly’s Donanemab Slows Clinical Decline of Alzheimer’s Disease in Positive Phase 2 Trial Lilly’s Donanemab Slows Clinical Decline of Alzheimer’s Disease in Positive Phase 2 Trial   BASINGSTOKE, January 12, 2021 – Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease compared to placebo in results from Eli Lilly and Company’s Phase 2 TRAILBLAZER-ALZ study. Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer s Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures in Alzheimer’s disease. Donanemab also

Lilly s Donanemab Slows Clinical Decline of Alzheimer s Disease in Positive Phase 2 Trial

advise column - You Docs

YOU DOCS Bounty of hope: Updates on aging, heart health and Alzheimer s Just in time for a holiday bonus, we are delighted to bring you a bouquet of breakthroughs. They re our New Year present of hope, shining a light on how medical science will continue to deliver life-changing improvements to your quality of life in the year ahead. Biological aging reversed! A three-month study has found that if folks 64 and older inhale pure oxygen through a mask while in a hyperbaric chamber for 90 minutes, five days a week, they lengthen their telomeres by an astounding 20 percent. That makes the telomeres - the ends of chromosomes that protect them from deterioration or fusion with neighboring genes - as long as they were when the study participants were 25 years younger. 

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