FDA Events for Cassava Sciences (SAVA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cassava Sciences (SAVA).
Over the past two years, Cassava Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Simufilam. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Simufilam - FDA Regulatory Timeline and Events
Simufilam is a drug developed by Cassava Sciences for the following indication: Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Simufilam
- Announced Date:
- June 30, 2025
- Indication:
- Alzheimer's Disease
Announcement
Cassava Sciences, Inc. announced that the Company presented a poster at the TSC International Research Conference (TSC 2025) held June 26-28, 2025 in Bethesda, MD.
AI Summary
Cassava Sciences, Inc. presented a research poster at the TSC International Research Conference (TSC 2025) held from June 26-28, 2025 in Bethesda, MD. The poster highlighted two key findings: preclinical data showing that simufilam reduced seizure frequency by 60% in a mouse model of focal onset seizures, and favorable safety data from two Phase 3 studies in nearly 2,000 Alzheimer’s patients. The preclinical results demonstrated that simufilam alleviated neuronal abnormalities in mice, supporting its potential as a treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy. These findings offer encouraging evidence as the company plans to commence human clinical studies in H1 2026 to further evaluate simufilam’s effectiveness and safety in patients with TSC-related epilepsy.
Read Announcement- Drug:
- Simufilam
- Announced Date:
- March 25, 2025
- Indication:
- Alzheimer's Disease
Announcement
Cassava Sciences, Inc. today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD.
AI Summary
Cassava Sciences, Inc. announced topline results from its Phase 3 REFOCUS-ALZ study, which assessed the investigational drug simufilam in patients with mild-to-moderate Alzheimer’s disease. The study enrolled 1,125 patients and aimed to measure changes in cognition and function over 76 weeks compared to a placebo. However, the results did not show a significant reduction in cognitive or functional decline for patients treated with simufilam, as the co-primary endpoints were not met. Despite the lack of efficacy, simufilam maintained an overall favorable safety profile throughout the study.
Following these clear results, Cassava Sciences announced that it will discontinue its Alzheimer’s disease development program for simufilam by the end of Q2 2025. The company remains committed to developing treatments for central nervous system disorders and will continue managing its strategic investments carefully.
Read Announcement- Drug:
- Simufilam
- Announced Date:
- January 7, 2025
- Indication:
- Alzheimer's Disease
Announcement
Cassava Sciences, Inc. provided a business update.
AI Summary
Cassava Sciences, Inc. provided a business update outlining several key changes. The company announced that it will discontinue its Phase 3 REFOCUS-ALZ trial and the associated Open Label Extension study. The topline results from REFOCUS-ALZ, which include both a complete 52-week dataset and a large portion of 76-week data, are expected to be released late in the first quarter or early in the second quarter of 2025.
Additionally, Cassava Sciences is implementing further cost-cutting measures, including reducing its workforce by 10 employees—about 33% of its staff—in the first quarter of 2025. The company is also halting planned biomarker analyses from previous Phase 2 studies. It reported unaudited cash and cash equivalents of approximately $128.6 million as of December 31, 2024.
Read Announcement- Drug:
- Simufilam
- Announced Date:
- November 25, 2024
- Indication:
- Alzheimer's Disease
Announcement
Cassava Sciences, Inc. announced that the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints.
AI Summary
Cassava Sciences announced that the topline results from its Phase 3 ReThink-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease did not meet the pre-specified co-primary endpoints, secondary endpoints, or exploratory biomarker measures. The study aimed to show improvements in cognition and daily function using tests like the ADAS-COG12 and ADCS-ADL scales, but the changes observed were not statistically significant compared to the placebo. Despite these findings, simufilam maintained an overall favorable safety profile for the patients.
The company plans to present additional data at an upcoming medical meeting and will host a webcast to discuss the results. Cassava Sciences acknowledged the disappointment for patients and families, while emphasizing their commitment to further analyzing the data to aid ongoing Alzheimer’s research and planning future steps in their clinical program.
Read Announcement- Drug:
- Simufilam
- Announced Date:
- September 24, 2024
- Indication:
- Alzheimer's Disease
Announcement
Cassava Sciences, Inc announced the completion of a third interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer's disease.
AI Summary
Cassava Sciences, Inc. recently announced the successful completion of the third interim safety review of its Alzheimer's drug candidate, simufilam, in ongoing Phase 3 clinical trials. An independent Data and Safety Monitoring Board (DSMB) conducted the review and recommended that both Phase 3 trials continue without any modifications. This review focused solely on patient safety, confirming that the treatment did not raise any new safety concerns as the trials progress.
The company plans to share top-line data, including safety, efficacy, and biomarker results, from a 12-month Phase 3 study by the end of 2024. Simufilam, a novel small molecule designed to target filamin A, is being evaluated in patients with mild-to-moderate Alzheimer’s disease. The continued trial progress bolsters hope for an effective treatment option for Alzheimer’s patients in the future.
Read Announcement- Drug:
- Simufilam
- Announced Date:
- July 30, 2024
- Indication:
- Alzheimer's Disease
Announcement
Cassava Sciences, Inc announced that the Company will extend by up to an additional 36 months each of the open-label extension trials in its ongoing Phase 2 and Phase 3 clinical programs.
AI Summary
Cassava Sciences, Inc. recently announced that each open-label extension trial in its ongoing Phase 2 and Phase 3 clinical programs will be extended by up to an additional 36 months. This extension allows patients who have participated in previous randomized simufilam trials for Alzheimer’s disease to continue receiving treatment if they choose. The extended trial period serves as a bridge between the end of the randomized trials and the FDA’s review of a new drug application for simufilam. Additionally, the company plans to include cognition and plasma biomarker monitoring in the trials. This extra monitoring aims to collect more long-term data on simufilam’s potential benefits for Alzheimer’s patients. Cassava Sciences emphasized that this decision reflects their commitment to patient care and responding to clinical research site requests, ensuring continued access to treatment while gathering important insights on the therapy’s effectiveness.
Read Announcement
Cassava Sciences FDA Events - Frequently Asked Questions
As of now, Cassava Sciences (SAVA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cassava Sciences (SAVA) has reported FDA regulatory activity for Simufilam.
The most recent FDA-related event for Cassava Sciences occurred on June 30, 2025, involving Simufilam. The update was categorized as "Poster Presentation," with the company reporting: "Cassava Sciences, Inc. announced that the Company presented a poster at the TSC International Research Conference (TSC 2025) held June 26-28, 2025 in Bethesda, MD."
Currently, Cassava Sciences has one therapy (Simufilam) targeting the following condition: Alzheimer's Disease.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SAVA) was last updated on 7/9/2025 by MarketBeat.com Staff
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