Shares of Cassava Sciences, Inc. (NASDAQ: SAVA) experienced a notable increase on Monday, reflecting investor optimism. The company’s stock closed the trading session at $35.08, marking a significant rise of 20.51% on the US stock charts. This uptick coincides with the company’s forthcoming conference call, scheduled for Thursday, August 8th at 8:30 a.m. Eastern Time, where it will outline recent advancements and provide an update on its progress.
Cassava Extended Clinical Trials Duration
Cassava Sciences has announced that it intends to extend its ongoing clinical programs’ open-label extension studies for a maximum of 36 months further. This change to the trial protocol is intended to enable participants who were part of a previous randomized simufilam study for Alzheimer’s disease to keep taking their medicine.
In clinical trials, the information gap between the end of patient treatment and the submission of trial data to regulatory bodies is intended to be filled by the extended open-label research.
The FDA will not be able to review a new application for a simufilam drug until after the limit of 36 months has passed. Furthermore, Cassava plans to incorporate cognitive and plasma biomarker monitoring in the open-label extension trials to collect additional long-term data on the effects of simufilam treatment.
Approximately 89% of participants from Cassava’s ongoing Phase 3 trials have opted to continue with the open-label treatment of simufilam post-blinded trials. Previously, around 100 patients had completed the open-label Phase 3 extension trial without further treatment options. These patients will now have the option, upon approval of the revised protocol modification, to re-enroll in an open-label extension experiment.
Leadership Changes
Additionally, Cassava nominated Richard (Rick) Barry as the company’s chief executive officer and Executive Chairman of the Board. SAVA is seeking a permanent replacement for its current CEO. Mr. Barry takes over for Remi Barbier, who resigned from the board and the corporation as chairman, president, and CEO. Until September 13, 2024, Mr. Barbier will continue to work for the company in a non-executive role with no obligations.
