Cassava Sciences To Start Two Pivotal Trials With Simufilam In Alzheimer's

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Cassava Sciences To Start Two Pivotal Trials With Simufilam In Alzheimer's

Benzinga2021-02-23

Cassava Sciences Inc (NASDAQ: SAVA) completes an End-of-Phase 2 (EOP2) meeting with the FDA for its lead candidate, simufilam, in Alzheimer's disease. The FDA and Cassava Sciences agree on key ...

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The FDA and Cassava Sciences agree on key ...</p>\n\n<a href=\"https://finance.yahoo.com/news/cassava-sciences-start-two-pivotal-171916454.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SAVA","symbol_name":"Cassava Sciences Inc","start_time":0,"source_url":"https://finance.yahoo.com/news/cassava-sciences-start-two-pivotal-171916454.html","article_id":"2113047128","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2113047128","pubTimestamp":1614014356,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Cassava Sciences Inc (NASDAQ: SAVA) completes an End-of-Phase 2 (EOP2) meeting with the FDA for its ","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"SAVA":"Cassava Sciences Inc"},"translate_title":"Cassava Sciences将启动西木菲仑治疗阿尔茨海默病的两项关键试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SAVA":0.9},"content_text":"Cassava Sciences Inc (NASDAQ: SAVA) completes an End-of-Phase 2 (EOP2) meeting with the FDA for its lead candidate, simufilam, in Alzheimer's disease. The FDA and Cassava Sciences agree on key elements of a pivotal Phase 3 program for simufilam, which would include two double-blind, randomized, placebo-controlled studies.\nFirst Phase 3 study will enroll approximately 1,000 subjects with mild-to-moderate Alzheimer's disease that will be treated for 18 months. Co-primary efficacy endpoints are a cognitive scale and a functional scale. Secondary efficacy endpoint combines cognitive and functional scores. The study will start in Q3 2021.\nSecond Phase 3 study in 600 mild-to-moderate Alzheimer's disease patients, who will be treated for 9 to 12 months. Primary and secondary efficacy endpoints remain the same as the first Phase 3 trial. It will start in Q4 of 2021. \nAs previously announced, the company plans to initiate a six-month Cognition Maintenance Study in Q2 2021 in patients who have completed at least one year of open-label treatment with simufilam.\nThe study will compare simufilam's effects on cognition and dementia-related in subjects who continue with drug treatment versus those who discontinue drug treatment. \nAlso, earlier this month, SAVA raised 0 million to fund the development of simufilam.\nPrice Action: SAVA gained 6.69% at $59.49 on the last check Monday.\n\nSee more from Benzinga\n\nClick here for options trades from Benzinga\nCassava Sciences Seeks 0M From Equity Offering At 15% Discount To Fund Development Of Lead Candidate\n\n© 2021 Benzinga.com. Benzinga does not provide investment advice. 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