Core Viewpoint - Cassava Sciences' stock experienced a significant decline after the company announced that its Phase 3 trial results for Simufilam, a treatment for Alzheimer's disease, did not meet primary endpoints, leading to a drop of over 80% in share price [2][8][16]. Company Update - Cassava Sciences reported that the topline results from the ReThink-ALZ study indicated that Simufilam did not show a significant reduction in cognitive or functional decline compared to placebo in patients with mild-to-moderate Alzheimer's disease [2][3]. - The CEO of Cassava Sciences, Rick Barry, described the trial results as "disappointing for patients and their families" [4]. Market Reaction - Following the announcement, shares of Cassava Sciences fell by 84.6%, trading at $4.06, marking a new 52-week low, with the previous trading range being $8.79 to $42.20 [16]. - Martin Shkreli, a notable figure in the pharmaceutical industry, had predicted the stock's decline and suggested that the stock could trade near its cash value levels of $2 to $3 per share [11][12]. Predictions and Commentary - Shkreli expressed confidence that the failure to meet the primary endpoint would make the stock an "easy short" and criticized the speculative nature of some investors in Cassava Sciences [10][11]. - Citron Research supported Shkreli's prediction, highlighting the challenges of shorting stocks like Cassava Sciences, which they described as having been a "clear fraud for years" [15].

Core Insights - Cassava Sciences shares are experiencing a significant decline, dropping 80% in premarket trading after the failure of its experimental drug Simufilam in a late-stage trial for Alzheimer's disease [2][7] - The drug did not demonstrate a significant reduction in cognitive or functional decline in patients with mild-to-moderate Alzheimer's, which is the most common cause of dementia [2][4] - The company plans to discontinue another late-stage study and an open-label study of Simufilam following the trial's failure [5] Company Actions - CEO Rick Barry expressed disappointment regarding the trial results, highlighting the impact on patients and families seeking new treatment options [3] - The company had previously agreed to a $40 million settlement with the SEC over allegations of manipulating clinical trial data related to Simufilam [6] Market Impact - The sharp decline in share price has reduced the year-to-date gain for Cassava Sciences to approximately 18% [7]

Core Viewpoint - Cassava Sciences Inc. experienced a significant decline in stock price following the release of disappointing topline data from the Phase 3 ReThink-ALZ study of simufilam for mild-to-moderate Alzheimer's disease [1][8]. Study Results - The Phase 3 ReThink-ALZ trial did not meet the pre-specified co-primary, secondary, and exploratory biomarker endpoints, which included changes in cognition and function assessed by ADAS-COG12 and ADCS-ADL scales [2]. - Despite the disappointing results, simufilam maintained an overall favorable safety profile [3]. Impact on Future Trials - The failed results from the ReThink-ALZ trial have led the company to discontinue its second Phase 3 trial, ReFocus-ALZ, as well as the Open Label Extension study [4]. Data Review and Future Plans - The complete 52-week dataset, along with a significant portion of the 76-week data, will be reviewed, and the company plans to share detailed results at a future medical meeting [5]. Regulatory Issues - Cassava Sciences has faced scrutiny for allegedly fabricating data from simufilam drug trials, resulting in a settlement of over $40 million with the SEC regarding misleading statements related to a Phase 2 trial [6]. - The SEC's investigation revealed that manipulated data was disclosed in September 2020, falsely indicating significant improvements in Alzheimer's biomarkers [7].

Core Insights - Simufilam did not demonstrate a significant reduction in cognitive or functional decline compared to placebo in patients with mild-to-moderate Alzheimer's disease in the ReThink-ALZ Phase 3 study [1][2] - The company plans to present the data at an upcoming medical meeting and will hold a webcast to discuss the results [1][7] - The overall safety profile of Simufilam remains favorable despite the study results [1][4] Study Details - The ReThink-ALZ trial involved 804 participants with mild or moderate Alzheimer's disease, randomized to receive either Simufilam 100 mg or a placebo for 52 weeks [8] - Co-primary endpoints included changes in cognition and function assessed by ADAS-COG12 and ADCS-ADL scales, with no statistical significance observed [3][9] - The loss of cognition in the placebo group was less pronounced than in previous studies, prompting further investigation [2] Safety and Demographics - The safety data indicated that 71.2% of Simufilam participants experienced any adverse event, compared to 67.6% in the placebo group [5][6] - The demographic data showed a mean age of 73.7 years for the Simufilam group and 74.3 years for the placebo group, with a balanced gender distribution [5][6] Future Plans - The company has decided to discontinue the ReFocus-ALZ trial and the Open Label Extension study due to the results of the ReThink-ALZ study [2] - Detailed analyses of both studies will be reported in the future [2][7] - Cassava Sciences remains focused on enhancing shareholder value and is well-capitalized with approximately $149 million in cash as of the end of Q3 2024 [7]

AUSTIN, Texas, Nov. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on developing a novel treatment for Alzheimer’s disease, today announced it will hold a conference call and webcast on Monday, November 25th at 8:00 a.m. Eastern Time.    Event Details:    Date: Monday, November 25th Time: 8:00 a.m. Eastern Time Webcast: https://lifescievents.com/event/cassava/    A replay of the audio webcast will also be available on the Company Pres ...

Ms. Nassif brings an extensive track record of successfully developing commercial strategies for multiple FDA-approved drugs Appointment initiates Cassava’s commercial readiness strategy as the Company prepares for first Phase 3 topline data readout before year end 2024 AUSTIN, Texas, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on developing a novel treatment for Alzheimer’s disease, today announced the appointment of Freda Nassif a ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Cassava Sciences, Inc. (SAVA) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Cassava Sciences, Inc. is one of 1024 companies in the Medical group. The M ...

Cassava Sciences, Inc. (SAVA) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Indivi ...

The inflammatory mediator peroxynitrite, when generated in excess, may damage cells by oxidizing and nitrating cellular components. Defense against this reactive species may be at the level of prevention of the formation of peroxynitrite, at the level of interception, or at the levelRetired history instructor. Alzheimer's disease researcher for the past two decades.My goal is to give investors solid advice based on the mechanisms of action of Alzheimer's drugs. This advice is informed by a background in bio ...

Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value SAVA Nasdaq Capital Market Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period fro ...