Cassava Sciences Receives FDA's Special Protocol Assessment For Alzheimer's Trials

Cassava Sciences Inc SAVA announced an agreement with the FDA under a Special Protocol Assessment (SPA) for both of its pivotal Phase 3 trials for oral simufilam in treating Alzheimer's disease.
The SPA document indicates that the regulator has reviewed and agreed to the critical design features of the trial protocols, the company said.
Cassava also reaffirmed its previously issued guidance to start the trials in Fall 2021.
"I believe these SPAs mark a meaningful and encouraging milestone for Cassava Sciences," CEO Remi Barbier noted.
"The SPAs underscore our alignment with FDA on key scientific, clinical, and regulatory requirements of our Phase 3 program of simufilam in Alzheimer's disease."
Also See: Cassava Sciences presented Phase 2 data for simufilam from an interim analysis of an open-label trial in patients with mild-to-moderate Alzheimer's.
Related content: Benzinga's Full FDA Calendar
Price Action: SAVA shares are up 1.66% at $117.53 during the market session on the last check Tuesday.