公司临床项目相关 - 公司的RETHINK - ALZ 52周3期试验预计在2024年底前公布主要数据 REFOCUS - ALZ预计2025年年中公布主要数据[1][9] - 公司3期项目包含两个全球性研究 目标人群为轻度至中度阿尔茨海默病患者 且生物标志物阳性并符合其他入选标准[2][3] - 3期试验中的RETHINK - ALZ研究药物为100mg片剂 每日两次 对比安慰剂持续52周 REFOCUS - ALZ研究两种剂量50mg和100mg片剂 每日两次 对比安慰剂持续76周 临床站点分布在美国加拿大等多地[4] - 两个3期研究已全部招募患者 RETHINK - ALZ约800名患者 REFOCUS - ALZ约1100名患者 约90%患者来自美国和加拿大 总体退出率RETHINK - ALZ为21% REFOCUS - ALZ为25%[5] - RETHINK - ALZ的LPLV几周前已发生 约635名患者完成 REFOCUS - ALZ至今超550名患者完成 共超1185名完成者[6] - DSMB由独立专家组成 2024年9月会议后建议两项3期研究按计划继续 与之前会议建议一致[7] - 3期研究的共同主要疗效结果为ADAS - Cog12和ADCS - ADL[8] - 所有3期项目疗效数据仍处于盲态 无疗效结果的中期分析计划[9] - 约88%完成3期研究的患者选择进入开放标签扩展研究 至今超1040名患者进入该研究 研究将持续36个月或直到simufilam的新药申请被FDA审查[10] 公司财务相关 - 2024年9月30日 公司现金及现金等价物为1.49亿美元 无债务[11] - 2024年第三季度净亏损2790万美元 每股0.58美元 相比2023年同期净亏损2570万美元 每股0.61美元[11] - 2024年前9个月运营净现金使用5570万美元 2024年下半年运营净现金使用预计4000 - 5000万美元 公司预计2024年底现金及现金等价物在1.17 - 1.27亿美元[11] - 2024年第三季度研发费用1770万美元 相比2023年同期2360万美元有所下降 主要因为3期临床项目患者筛选和招募完成[11] - 2024年第三季度一般和管理费用1290万美元 相比2023年同期430万美元显著增加 主要由于法律相关费用增加等[11] 公司其他相关 - 公司是位于德克萨斯州奥斯汀的临床阶段生物技术公司 使命是检测和治疗神经退行性疾病如阿尔茨海默病[12] - simufilam是一种在研口服小分子候选药物 正在进行两项3期临床试验 公司拥有其全球独家权利[13] - 公司将进行网络直播 时间为11月7日上午8:30[12]

AUSTIN, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, announced today that it will hold a conference call on Thursday, November 7th at 8:30 a.m. Eastern Time.   Event details:  Date:Thursday, November 7thTime:8:30 a.m. Eastern TimeAudio Webcast:https://www.CassavaSciences.com/company-presentationsOrAudio Webcast:https://edge.media-server.com/mmc/p/tzb9j3sy   A replay of the audio webcast will also be ava ...

Cassava Sciences Today SAVA Cassava Sciences $26.52 -0.21 (-0.79%) 52-Week Range $8.79 ▼ $42.20 Price Target $111.50 Add to Watchlist Cassava Sciences Inc. NASDAQ: SAVA is a biotech developing treatments for Alzheimer's disease. The company has a lot of controversy over its lead drug, simufilam, which attempts to go further than alleviate symptoms but actually modify the underlying biology of the disease. While the concept sounds fascinating, the problems for the medical sector company lie in the credibilit ...

Cassava Sciences (SAVA) has agreed to pay a $40 million fine to settle charges from the U.S. Securities and Exchange Commission (SEC) over allegedly misleading statements about the results of its 2020 mid-stage study of simufilam for Alzheimer's disease. Despite settling, the company did not admit to or deny the SEC's allegations. The SEC also brought charges against two former senior executives, including founder and ex-CEO Remi Barbier and former senior vice president of Neuroscience, Dr. Lindsay Burns. T ...

Without admitting wrongdoing, the company put a regulatory controversy to rest, but this was expensive. Cassava Sciences (SAVA -10.62%) ended the week with a piece of dispiriting news. It's going to reach deep into its coffers to settle charges brought by the most important financial-markets regulator governing its affairs. Many investors had enough of the company and sold off its stock to the point where it lost nearly 11% of its value across the Friday trading session. That was a far steeper fall than the ...

Alzheimer's drug developer Cassava Sciences Inc SAVA, its founder Remi Barbier, and former Senior VP of Neuroscience Lindsay Burns have agreed to pay over $40 million to resolve SEC charges over misleading statements related to a Phase 2 trial of the company's controversial Alzheimer's drug, simufilam. The SEC also charged Hoau-Yan Wang, a consultant and co-developer of the drug, with manipulating trial results. The SEC's investigation found that in September 2020, Cassava disclosed manipulated data from th ...

AUSTIN, Texas, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. ("Cassava" or the "Company") (Nasdaq: SAVA), a biotechnology company focused on Alzheimer's disease, today announced that it has reached a settlement with the U.S. Securities and Exchange Commission ("SEC") of negligence-based disclosure charges that resolve a previously-disclosed SEC investigation into statements made by the Company pertaining to the results of its 2020 Phase 2b clinical trial of simufilam and related matters. Two for ...

Washington, D.C.--(Newsfile Corp. - September 26, 2024) - The Securities and Exchange Commission today announced Cassava Sciences, Inc., its founder and former CEO, Remi Barbier, and its former Senior Vice President of Neuroscience, Dr. Lindsay Burns, will pay more than $40 million to settle charges related to misleading statements made in September 2020 about the results of a Phase 2 clinical trial for the company's purported therapeutic for the treatment of Alzheimer's disease. In a related order, the SEC ...

An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. AUSTIN, Texas, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer's disease, today announced the completion ...

Cassava Sciences Today SAVA Cassava Sciences $21.85 -4.17 (-16.03%) 52-Week Range $8.79 ▼ $42.20 Price Target $119.00 Add to Watchlist Cassava Sciences NASDAQ: SAVA has become a hot topic among traders and active market participants thanks to its recent surge in volatility, liquidity, and overall market performance. Over the past month, shares have climbed 133% and are now more than 190% above their 52-week low. With its recent spike and increasing volatility and popularity in the headlines, the question ar ...