Cassava Sciences (FLNA) FDA Approvals $1.29 +0.04 (+3.20%) As of 03:02 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Upcoming FDA Events for Cassava Sciences Cassava Sciences (FLNA) has upcoming FDA regulatory milestones for Simufilam. The table below outlines estimated target dates and event types for these pending regulatory actions. DrugTarget DateAnnouncement SimufilamH1 2026Clinical StudyCassava Sciences, Inc. announced that First clinical study for simufilam in TSC-related epilepsy expected to begin in H1 2026 (August 4, 2025) Cassava Sciences' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Cassava Sciences (FLNA). 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. Publication - January 13,2026Publication Drug: SimufilamAnnounced Date: January 13, 2026Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. announced publication of the article Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease in an upcoming issue of the Journal of Prevention of Alzheimer's Disease (JPAD).AI SummaryCassava Sciences announced publication in the Journal of Prevention of Alzheimer’s Disease of a paper analyzing its two Phase 3 simufilam trials in mild-to-moderate Alzheimer’s: RETHINK‑ALZ (N=804) and REFOCUS‑ALZ (N=1,125). The paper confirms that both trials missed their prespecified co‑primary, secondary, and biomarker endpoints, but reports a favorable safety profile for simufilam. Exploratory and some prespecified secondary analyses suggested possible cognitive benefits for the 100 mg dose in predefined mild patients in REFOCUS at multiple time points, though this result did not replicate in RETHINK. A pooled analysis of mild patients showed early differences, and a post‑hoc analysis using higher plasma p‑tau181 levels showed signals through week 40. An amyloid PET sub‑study found 21% of scanned participants were amyloid‑negative, indicating the plasma p‑tau181 cutoff used for enrollment may have missed non‑AD cases. Cassava has discontinued further Alzheimer’s development and has made the data public on JPAD. The company says the paper can inform future Alzheimer’s research and notes the safety findings support its work in TSC‑related epilepsy. Read AnnouncementClinical Study - August 4,2025Clinical Study Drug: SimufilamAnnounced Date: August 4, 2025Target Action Date: H1 2026Estimated Target Date Range: January 1, 2026 - June 30, 2026Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. announced that First clinical study for simufilam in TSC-related epilepsy expected to begin in H1 2026AI SummaryCassava Sciences, Inc. reported positive results from a lab study of its oral drug, simufilam, in a mouse model of tuberous sclerosis complex (TSC)–related epilepsy. The research was done with the TSC Alliance using Tsc1-knockout mice that naturally develop seizures. Simufilam showed a clear dose-dependent reduction in seizure activity compared to untreated mice. This independent study supports earlier findings in a different animal model and suggests simufilam could be a new, first-in-class therapy for patients whose seizures are not controlled by existing treatments. Results will be shared at an upcoming scientific conference and in a peer-reviewed journal. Cassava plans to start its first clinical trial of simufilam for TSC-related epilepsy in the first half of 2026. The proof-of-concept study will assess safety and initial effectiveness in people with TSC who continue to experience seizures.Read AnnouncementPositive Results - August 4,2025Positive Results Drug: SimufilamAnnounced Date: August 4, 2025Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. today reported positive preclinical results of a study evaluating simufilam in a well-accepted mouse model of tuberous sclerosis complex (TSC)-related epilepsy.AI SummaryCassava Sciences reported positive preclinical results from a study testing simufilam in a mouse model of tuberous sclerosis complex (TSC)-related epilepsy. Simufilam reduced seizure activity in a well-known Tsc1 conditional knockout mouse line in a dose-dependent manner. The study was done with the TSC Alliance. Researchers treated mice with several simufilam doses and compared results to untreated animals. Higher doses led to fewer seizures by study end. This matches earlier work at Yale School of Medicine in another epilepsy model. Cassava will share data at an upcoming conference and in a paper. These results support simufilam as a potential first-in-class treatment for TSC-related epilepsy. Based on these data, Cassava expects to start the first clinical study of simufilam in TSC-related epilepsy in the first half of 2026, offering new hope for patients with treatment-resistant seizures.Read AnnouncementPoster Presentation - June 30,2025Poster Presentation Drug: SimufilamAnnounced Date: June 30, 2025Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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 AnnouncementTop-line results - March 25,2025Top-Line Results Phase 3Drug: SimufilamAnnounced Date: March 25, 2025Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD.AI SummaryCassava 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 AnnouncementProvided Update - January 7,2025Provided Update Drug: SimufilamAnnounced Date: January 7, 2025Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. provided a business update.AI SummaryCassava 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 AnnouncementTop-line results - November 25,2024Top-Line Results Phase 3Drug: SimufilamAnnounced Date: November 25, 2024Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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 AnnouncementClinical Trial - September 24,2024Clinical Trial Phase 3Drug: SimufilamAnnounced Date: September 24, 2024Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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 AnnouncementProvided Update - July 30,2024Provided Update Drug: SimufilamAnnounced Date: July 30, 2024Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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 Has Cassava Sciences received FDA approval? As of now, Cassava Sciences (FLNA) has not received any FDA approvals for its therapy in the last two years. What drugs has Cassava Sciences submitted to the FDA? In the past two years, Cassava Sciences (FLNA) has reported FDA regulatory activity for Simufilam. What is the most recent FDA event for Cassava Sciences? The most recent FDA-related event for Cassava Sciences occurred on January 13, 2026, involving Simufilam. The update was categorized as "Publication," with the company reporting: "Cassava Sciences, Inc. announced publication of the article Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease in an upcoming issue of the Journal of Prevention of Alzheimer's Disease (JPAD)." What conditions do Cassava Sciences' current drugs treat? Currently, Cassava Sciences has one therapy (Simufilam) targeting the following condition: Alzheimer's Disease. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia FDA Events 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 Related Companies Alector FDA Events Minerva Neurosciences FDA Events Coherus Oncology FDA Events Whitehawk Therapeutics FDA Events Entrada Therapeutics FDA Events Tonix Pharmaceuticals FDA Events Foghorn Therapeutics FDA Events Artiva Biotherapeutics FDA Events Voyager Therapeutics FDA Events Inhibikase Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:FLNA last updated on 1/13/2026 by MarketBeat.com Staff. 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Publication - January 13,2026Publication Drug: SimufilamAnnounced Date: January 13, 2026Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. announced publication of the article Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease in an upcoming issue of the Journal of Prevention of Alzheimer's Disease (JPAD).AI SummaryCassava Sciences announced publication in the Journal of Prevention of Alzheimer’s Disease of a paper analyzing its two Phase 3 simufilam trials in mild-to-moderate Alzheimer’s: RETHINK‑ALZ (N=804) and REFOCUS‑ALZ (N=1,125). The paper confirms that both trials missed their prespecified co‑primary, secondary, and biomarker endpoints, but reports a favorable safety profile for simufilam. Exploratory and some prespecified secondary analyses suggested possible cognitive benefits for the 100 mg dose in predefined mild patients in REFOCUS at multiple time points, though this result did not replicate in RETHINK. A pooled analysis of mild patients showed early differences, and a post‑hoc analysis using higher plasma p‑tau181 levels showed signals through week 40. An amyloid PET sub‑study found 21% of scanned participants were amyloid‑negative, indicating the plasma p‑tau181 cutoff used for enrollment may have missed non‑AD cases. Cassava has discontinued further Alzheimer’s development and has made the data public on JPAD. The company says the paper can inform future Alzheimer’s research and notes the safety findings support its work in TSC‑related epilepsy. Read Announcement
Clinical Study - August 4,2025Clinical Study Drug: SimufilamAnnounced Date: August 4, 2025Target Action Date: H1 2026Estimated Target Date Range: January 1, 2026 - June 30, 2026Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. announced that First clinical study for simufilam in TSC-related epilepsy expected to begin in H1 2026AI SummaryCassava Sciences, Inc. reported positive results from a lab study of its oral drug, simufilam, in a mouse model of tuberous sclerosis complex (TSC)–related epilepsy. The research was done with the TSC Alliance using Tsc1-knockout mice that naturally develop seizures. Simufilam showed a clear dose-dependent reduction in seizure activity compared to untreated mice. This independent study supports earlier findings in a different animal model and suggests simufilam could be a new, first-in-class therapy for patients whose seizures are not controlled by existing treatments. Results will be shared at an upcoming scientific conference and in a peer-reviewed journal. Cassava plans to start its first clinical trial of simufilam for TSC-related epilepsy in the first half of 2026. The proof-of-concept study will assess safety and initial effectiveness in people with TSC who continue to experience seizures.Read Announcement
Positive Results - August 4,2025Positive Results Drug: SimufilamAnnounced Date: August 4, 2025Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. today reported positive preclinical results of a study evaluating simufilam in a well-accepted mouse model of tuberous sclerosis complex (TSC)-related epilepsy.AI SummaryCassava Sciences reported positive preclinical results from a study testing simufilam in a mouse model of tuberous sclerosis complex (TSC)-related epilepsy. Simufilam reduced seizure activity in a well-known Tsc1 conditional knockout mouse line in a dose-dependent manner. The study was done with the TSC Alliance. Researchers treated mice with several simufilam doses and compared results to untreated animals. Higher doses led to fewer seizures by study end. This matches earlier work at Yale School of Medicine in another epilepsy model. Cassava will share data at an upcoming conference and in a paper. These results support simufilam as a potential first-in-class treatment for TSC-related epilepsy. Based on these data, Cassava expects to start the first clinical study of simufilam in TSC-related epilepsy in the first half of 2026, offering new hope for patients with treatment-resistant seizures.Read Announcement
Poster Presentation - June 30,2025Poster Presentation Drug: SimufilamAnnounced Date: June 30, 2025Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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
Top-line results - March 25,2025Top-Line Results Phase 3Drug: SimufilamAnnounced Date: March 25, 2025Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD.AI SummaryCassava 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
Provided Update - January 7,2025Provided Update Drug: SimufilamAnnounced Date: January 7, 2025Indication: Alzheimer's DiseaseAnnouncementCassava Sciences, Inc. provided a business update.AI SummaryCassava 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
Top-line results - November 25,2024Top-Line Results Phase 3Drug: SimufilamAnnounced Date: November 25, 2024Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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
Clinical Trial - September 24,2024Clinical Trial Phase 3Drug: SimufilamAnnounced Date: September 24, 2024Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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
Provided Update - July 30,2024Provided Update Drug: SimufilamAnnounced Date: July 30, 2024Indication: Alzheimer's DiseaseAnnouncementCassava 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 SummaryCassava 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
