The market is sinking in a furious mood caused by the failure to figure out the pathway of criteria, which is currently controlling the stocks’ volatile performances. Today we are posting good news coming from a few biotech companies with solid fundamentals. Unfortunately, all of these firms are tumbling instead of soaring, or at least performing positively. Look for them under Impacting News.
Cassava Sciences (SAVA) announced the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for simufilam, its drug candidate for Alzheimer’s disease.
The official EOP2 meeting minutes indicate that the FDA and Cassava Sciences have agreed on key elements of a pivotal Phase 3 clinical program in support of a New Drug Application (NDA) filing for simufilam in Alzheimer’s disease.
The agreements reached during the meeting have demonstrated a clear path forward for advancing simufilam into Phase 3 studies in the second half of 2021. The meeting discussion was supported by years of scientific and clinical data, including positive results from a previously completed Phase 2 clinical program with simufilam in Alzheimer’s disease.