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. (NASDAQ: SAVA) is a clinical-stage biotechnology company based in Austin, Texas that reports extensively on its efforts to develop simufilam, a proprietary, investigational oral small molecule for central nervous system (CNS) disorders. Recent news emphasizes a strategic shift toward tuberous sclerosis complex (TSC)-related epilepsy, following the discontinuation of its Alzheimer’s disease program after two Phase 3 trials did not meet their pre-specified endpoints.
News updates for SAVA commonly cover preclinical and clinical development milestones. Cassava has announced preclinical studies in mouse models of TSC-related epilepsy and focal cortical malformations, reporting that simufilam reduced seizure activity and alleviated neuronal abnormalities. The company also highlights presentations at scientific meetings, such as the TSC International Research Conference, where it shared data on seizure reduction and human safety findings from prior Alzheimer’s Phase 3 studies.
Regulatory and corporate developments are another key theme in Cassava’s news flow. Items include disclosures about the FDA placing the proposed proof-of-concept trial of simufilam in TSC-related epilepsy on full clinical hold pending additional data and protocol changes, as well as updates on the timing implications for clinical trial initiation. Investors also see announcements about leadership appointments in neuroscience and clinical development, board changes, participation in investor conferences, and financial results with commentary on cash resources and expense management.
Litigation and legal matters feature in Cassava’s news as well. The company has reported a binding term sheet to settle a consolidated securities class action for $31.25 million, subject to court approval, and has discussed related loss contingencies in its financial communications. For anyone tracking SAVA, this news page provides ongoing coverage of scientific publications, regulatory interactions, corporate governance changes, and financial and legal updates related to Cassava’s CNS drug development programs.
Cassava (NASDAQ: SAVA) announced publication of a peer-reviewed JPAD article reporting detailed results from the Phase 3 RETHINK-ALZ (N=804) and REFOCUS-ALZ (N=1,125) trials of simufilam in mild-to-moderate Alzheimer’s disease, dated January 13, 2026. The paper confirms the studies did not meet prespecified co-primary, secondary, or exploratory biomarker endpoints, but reports a favorable safety profile and exploratory/post-hoc signals in predefined mild subgroups and pooled analyses at weeks 4–52 (nominal p-values reported). The company has discontinued development and plans no further investment in the Alzheimer’s program.
Cassava Sciences (NASDAQ: SAVA) announced a definitive agreement to settle the consolidated securities class action (In re Cassava Sciences, No. 1:21-cv-00751-DAE) for $31.25 million, resolving claims tied to purchases or option trades between September 14, 2020 and October 12, 2023 (with exclusions).
The settlement provides a complete release of the defined plaintiff class, is not an admission of fault, and remains subject to court approval and potential consolidation of later-filed related suits. Cassava previously recorded a $31.25 million loss contingency in Q2 2025 for this matter. Management said the resolution allows focus on advancing simufilam for TSC-related epilepsy.
Cassava Sciences (NASDAQ: SAVA) reported Q3 2025 results and a business update on Nov 12, 2025. The company had $106.1M cash at Sept 30, 2025 and estimates year-end 2025 cash of $92–$96M, after incremental Q4 cash use of $10–$14M. Net loss narrowed to $10.8M ($0.22/share) in Q3 2025 from $27.9M a year earlier. R&D expense fell 78% to $4.0M as the Alzheimer’s program was phased out. Cassava plans a proof-of-concept study of simufilam for TSC-related epilepsy in H1 2026, citing positive preclinical results and recent hires including a part-time CMO and a new independent director.
Cassava Sciences (NASDAQ: SAVA) appointed Dawn C. Bir to its Board of Directors effective Oct. 22, 2025.
Ms. Bir is a seasoned biopharmaceutical executive with prior leadership and board roles at Geron (GERN), Soleno Therapeutics (SLNO), Reata (acquired by Biogen), Pharmacyclics (acquired by AbbVie), Genentech, McKesson, and Bristol-Myers Squibb. Management says the appointment strengthens strategic and commercial expertise as Cassava plans to initiate its first clinical study of simufilam in TSC-related epilepsy in the first half of 2026.
Cassava Sciences (NASDAQ: SAVA), a biotechnology company specializing in novel treatments for central nervous system (CNS) disorders, has announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference.
The company's President and CEO, Rick Barry, will deliver a corporate presentation on Monday, September 8, 2025, at 5 PM ET in New York City. The presentation will be available via webcast, with a replay accessible on Cassava's investor website for approximately 90 days after the event.
Cassava Sciences (NASDAQ: SAVA) reported Q2 2025 financial results and provided significant business updates. The company recorded a net loss of $44.2 million, compared to net income of $6.2 million in Q2 2024, primarily due to a $31.25 million loss contingency for securities litigation settlement.
Key developments include advancing simufilam for TSC-related epilepsy treatment, with promising preclinical results showing a 60% reduction in seizure frequency in mouse models. The company plans to initiate a proof-of-concept study in H1 2026. Cassava strengthened its leadership team with experienced neuroscience professionals, including Dr. Joseph Hulihan as CMO.
Financial position remains solid with $112.4 million in cash as of June 30, 2025, with projected year-end cash between $61-65 million. R&D expenses decreased 66% to $5.1 million due to the completion of the Alzheimer's disease program.
Cassava Sciences (NASDAQ: SAVA) has appointed Dr. Joseph Hulihan as Chief Medical Officer (CMO). Dr. Hulihan, who will dedicate approximately half of his professional time to Cassava, brings over 25 years of industry experience specializing in epilepsy and neurological disorders therapeutics development.
Dr. Hulihan will advise on the clinical development of simufilam, Cassava's investigational treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy. The company plans to initiate a proof-of-concept clinical study in H1 2026. Previously, he served as CMO at Marinus Pharmaceuticals and held senior positions at Johnson & Johnson, contributing to over 25 late-stage neurology clinical trials and authoring more than 70 published papers.
Cassava Sciences (NASDAQ: SAVA) has reported positive preclinical results for simufilam in treating tuberous sclerosis complex (TSC)-related epilepsy. The study, conducted with the TSC Alliance, demonstrated that simufilam showed beneficial effects on seizure activity with a positive dose response in a Tsc1-knockout mouse model.
The research validates previous findings published in Science Translational Medicine and supports simufilam's potential as a first-in-class treatment for TSC-related epilepsy. The study showed statistically significant correlation between simufilam dose and reduced seizure numbers. The company plans to initiate a proof-of-concept clinical study in H1 2026.
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.
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