Free Trial

Cassava Sciences (SAVA) FDA Events

Cassava Sciences logo
$2.19 +0.11 (+5.29%)
Closing price 04:00 PM Eastern
Extended Trading
$2.18 -0.01 (-0.46%)
As of 07:56 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
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.

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

  • 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
From Our Partners