Raymond James raised its price target for Alpha Cognition (TSXV:ACOG) to $3.50 (Canadian) from $2.50 and maintained its “outperform” rating after the FDA accepted Alpha’s IND application to proceed into a pivotal clinical trial with its lead candidate, Alpha-1062.
Alpha’s lead asset, Alpha-1062, is a novel, patented pro-drug of galantamine: a widely-used, FDA-approved treatment for patients with mild-to-moderate Alzheimer’s disease.
According to analyst Rahul Sarugaser, Ph.D., the pivotal trial expects to enroll 80 patients in a cross-over study, with the first patient enrolled in early-to-mid October, followed by four weeks for the cross-over treatment.
Dr. Sarugaser estimates Alpha could conclude the trial by the end of November or early December, presenting topline data before end of 2021. “The quality of this data will be critical to our estimate of Alpha-1062’s likelihood of FDA approval,” he added.
In addition, he expects the company to submit its NDA to the FDA in July or August 2022.