NEW YORK, Dec. 13, 2024 /PRNewswire/ --Why: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of Cassava Sciences, Inc. (NASDAQ: SAVA) between February 7, 2024 and November 24, 2024, both dates inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than February 10, 2025.So what: If you purchased Cassava securities during the C ...

Cassava Sciences’ (SAVA) stock shed more than 80% of market value on Monday after the company reported that its lead pipeline drug, simufilam, failed to meet the primary endpoints in a late study for Alzheimer’s disease (AD).SAVA releases top-line results from the ReThink-ALZ study, which evaluated simufilam in patients with mild-to-moderate AD. Treatment with the drug failed to achieve a significant reduction in cognitive or functional decline in AD patients when compared to placebo over a 52-week period, ...

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]

Core Viewpoint - Cassava Sciences, Inc. is set to hold a conference call and webcast to discuss developments related to its Alzheimer's disease treatment on November 25, 2024 [1][2]. Company Overview - Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas, focused on detecting and treating neurodegenerative diseases, particularly Alzheimer's disease [3]. - The company owns exclusive, worldwide rights to its investigational product candidates and related technologies, including Simufilam, without royalty obligations to any third party [4]. Product Information - Simufilam is an investigational oral small molecule drug candidate currently being evaluated in two Phase 3 clinical trials for the potential treatment of Alzheimer's disease [4].

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 ...