Welcome to our dedicated page for Cassava Sciences news (Ticker: SAVA), a resource for investors and traders seeking the latest updates and insights on Cassava Sciences stock.
Cassava Sciences, Inc. (SAVA) is a clinical-stage biotechnology company pioneering Alzheimer's disease research through therapeutic candidate simufilam and diagnostic tool SavaDx. This page aggregates official press releases, regulatory updates, and material event announcements directly from the company and verified sources.
Investors and researchers will find timely updates on Phase 3 clinical trial progress, FDA communications, intellectual property developments, and peer-reviewed study publications. Our curated feed ensures access to SAVA's critical milestones in drug development and diagnostic innovation without promotional commentary.
Key content categories include clinical trial results, partnership announcements with research institutions, financial disclosures related to R&D funding, and scientific presentations at major medical conferences. All materials are organized chronologically to track the company's evolving research narrative.
Bookmark this page for streamlined monitoring of Cassava Sciences' advancements in Alzheimer's therapeutics. For comprehensive analysis, cross-reference updates with SEC filings and scientific publications linked in source materials.
Cassava Sciences (NASDAQ: SAVA) presented promising preclinical data for simufilam in treating Tuberous Sclerosis Complex (TSC)-related epilepsy at the TSC International Research Conference. The research demonstrated that simufilam reduced seizure frequency by 60% compared to vehicle in a mouse model of focal onset seizures.
Key findings from the preclinical studies conducted at Yale School of Medicine showed statistically significant seizure reduction (p<0.0001) and improved seizure freedom rates (11/32 simufilam-treated mice vs 3/29 vehicle-treated mice, p=0.0343). The effective dose was 20 mg/kg/day, with no adverse effects observed at doses up to 50 mg/kg/day in rats and 1250 mg/kg/day in mice.
Additionally, the company presented favorable human safety data from two Phase 3 studies involving 1,929 patients with mild-to-moderate Alzheimer's disease. The safety profile showed only mild, non-serious adverse events typically unrelated to simufilam, with no serious adverse events assessed as study-drug related. Cassava plans to initiate human clinical studies for TSC-related epilepsy in H1 2026.
Cassava Sciences (NASDAQ: SAVA) has appointed Dr. Angélique Bordey as Senior Vice President of Neuroscience to lead the company's research and development efforts. Dr. Bordey, who currently serves as Vice Chair of the Department of Neurosurgery at Yale School of Medicine, will maintain her academic position part-time while focusing on evaluating simufilam as a potential treatment for TSC-related epilepsy and other pipeline indications.
Dr. Bordey's research, published in prestigious journals, was fundamental to Cassava's recently granted patent for using simufilam to treat TSC-related epilepsy. The company has secured a license agreement with Yale University for this patent. Her expertise in neuroscience and leadership in the TSC community is expected to advance Cassava's preclinical program and facilitate study collaborations.
Cassava Sciences (NASDAQ: SAVA) announced key leadership changes in its clinical development team. Dr. James W. Kupiec, Chief Medical Officer, will retire effective May 9, 2025, after completing the company's Alzheimer's disease clinical trial program. Dr. Jack Moore has been appointed as Senior Vice President of Clinical Development, effective April 28, 2025.
Dr. Moore will focus on advancing the clinical evaluation of simufilam for new potential indications, including tuberous sclerosis complex (TSC)-related epilepsy. He brings extensive experience in medical affairs and clinical development from leading global pharmaceutical companies, particularly in CNS disorders.
Cassava Sciences (NASDAQ: SAVA) announced that its Phase 3 REFOCUS-ALZ study of simufilam for mild-to-moderate Alzheimer's disease failed to meet its primary endpoints. The trial, involving 1,125 patients, showed no significant reduction in cognitive or functional decline compared to placebo over 76 weeks.
The study was discontinued on November 25, 2024, following similar negative results from another Phase 3 trial, RETHINK-ALZ. While simufilam demonstrated a favorable safety profile, Cassava will completely discontinue its Alzheimer's disease development program by Q2 2025.
The company plans to redirect efforts toward evaluating simufilam for TSC-related epilepsy in preclinical studies. As of December 31, 2024, Cassava maintains a strong financial position with approximately $128.6 million in cash and cash equivalents.
Cassava Sciences (NASDAQ: SAVA) reported its 2024 financial results, highlighting key developments in its clinical programs. The company expects top-line data from REFOCUS-ALZ, its second Phase 3 study of simufilam in Alzheimer's disease, in late Q1/early Q2 2025. This follows the November 2024 RETHINK-ALZ study, which failed to meet its co-primary endpoints, leading to the discontinuation of all Alzheimer's disease clinical studies.
The company ended 2024 with $128.6 million in cash and no debt. Net loss decreased to $24.3 million ($0.53 per share) in 2024 from $97.2 million in 2023. R&D expenses decreased to $69.6 million from $89.4 million, while G&A expenses increased to $71.8 million from $16.5 million, primarily due to a $40 million SEC settlement.
Cassava has entered a new licensing agreement with Yale University to explore simufilam's potential in treating tuberous sclerosis complex (TSC)-related seizures. The company projects $16-20 million in net cash use for H1 2025.
Cassava Sciences (NASDAQ: SAVA) has secured a license agreement with Yale University for intellectual property rights, including an exclusive license to a US method of treatment patent for simufilam as a potential treatment for seizures related to rare neurodevelopmental disorders, particularly tuberous sclerosis complex (TSC).
The licensed patent stems from research led by Dr. Angélique Bordey at Yale, published in Science Translational Medicine in 2020. The study demonstrated that simufilam, Cassava's proprietary small molecule drug candidate targeting filamin A, showed promising results in reducing TSC-related seizure frequency in animal models.
The company plans to conduct preclinical studies in collaboration with the TSC Alliance to evaluate simufilam's potential as a treatment for TSC-related seizures and determine future development steps.
Cassava Sciences (NASDAQ: SAVA) has announced significant updates following its Phase 3 RETHINK-ALZ study's failure to meet primary endpoints in November 2024. The company is proceeding with the discontinuation of both the Phase 3 REFOCUS-ALZ and Open Label Extension studies, with topline results expected in late Q1/early Q2 2025.
As part of strategic cost-cutting measures, Cassava is implementing a 33% workforce reduction, affecting 10 employees in Q1 2025. The company is also halting planned biomarker analysis of additional plasma samples from prior Phase 2 studies. The workforce reduction will incur approximately $0.4 million in one-time costs.
The company reports unaudited cash and cash equivalents of $128.6 million as of December 31, 2024.
Cassava Sciences announced that its Phase 3 ReThink-ALZ study of simufilam for mild-to-moderate Alzheimer's disease failed to meet its co-primary, secondary, and exploratory biomarker endpoints. The study evaluated changes in cognition and function over 52 weeks using ADAS-COG12 and ADCS-ADL scales. Due to these disappointing results, the company is discontinuing its second Phase 3 trial, ReFocus-ALZ, and the Open Label Extension study. Simufilam maintained a favorable safety profile throughout the trial. The company reported approximately $149.0 million in cash and cash equivalents as of Q3 2024.
Cassava Sciences (NASDAQ: SAVA) announced it will host a corporate update via conference call and webcast on Monday, November 25th at 8:00 AM ET. The biotechnology company, which focuses on developing novel Alzheimer's disease treatments, will make the webcast available through their website, with a replay accessible for 90 days following the event on the Company Presentations page.
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