Cassava Sciences, Inc.
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1998-01-01
- Employees
- 29
- Market Cap
- -
Cassava Sciences Announces Workforce Reduction and Provides Update on Alzheimer's Program
• Cassava Sciences is reducing its workforce by approximately 33% as part of cost-saving measures following Phase 3 trial results.
• Topline data from the REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer's is expected in late Q1 or early Q2 2025.
• The company's cash and cash equivalents were approximately $128.6 million as of December 31, 2024, before cost curtailment.
• Cassava Sciences remains dedicated to developing novel medicines for central nervous system disorders despite recent setbacks.
Cassava Sciences Faces Class Action Lawsuit After Simufilam Fails Phase 3 Trial
• A class action lawsuit has been filed against Cassava Sciences, alleging securities fraud related to its Alzheimer's drug candidate, simufilam.
• The lawsuit follows the release of topline results from the Phase 3 ReThink-ALZ study, where simufilam failed to meet its primary and secondary endpoints.
• Cassava's stock price plummeted by approximately 83.76% after the announcement of the trial results, leading to significant investor losses.
• Investors who suffered losses between February 7, 2024, and November 24, 2024, are encouraged to join the class action suit to seek potential recovery.
Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development
• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases.
• Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact.
• MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned.
• The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.
Cassava Sciences' Simufilam Maintains Safety Profile in Phase 3 Alzheimer's Trials
• An independent Data and Safety Monitoring Board (DSMB) has endorsed the continuation of Cassava Sciences' Phase 3 trials for simufilam in Alzheimer's disease.
• The DSMB's recommendation is based on an interim safety review, with no modifications suggested for the ongoing clinical trials.
• Top-line results from the first Phase 3 trial, involving 804 patients over 52 weeks, are anticipated by the end of 2024.
• Simufilam, a small molecule drug, targets filamin A and has shown no association with treatment-emergent ARIA in interim MRI data.
Alzheimer's Disease and Gene Therapy Clinical Trials Show Promise with Novel Approaches
• Over 120 Alzheimer's Disease treatment therapies are under development globally, targeting various mechanisms of action and routes of administration.
• Gene therapy is emerging as a potential treatment strategy, with over 300 gene therapy drugs in the pipeline for various diseases, including neurological disorders.
• Several companies are advancing Alzheimer's therapies through clinical trials, including Phase 3 studies for small molecule candidates and Phase 1 trials for novel muscarinic agonists.
• Recent FDA approval of Leqembi marks a significant milestone, highlighting the potential of amyloid beta-directed antibodies in treating Alzheimer's disease.
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