Raymond James upgraded Alpha Cognition (CSE:ACOG) to “outperform” from “market perform” and raised its price target to C$2 from C$1 with the company’s PDUFA date less than 2 weeks away (July 27th). The stock closed at 76 cents on July 12.
ACOG’s NDA is currently under review with the FDA. Given ALPHA-1062’s regulatory path hinges on safety and bioequivalence with galantamine (an approved and commonly-prescribed generic), “we see this as a relatively low-risk regulatory process—particularly given ALPHA-1062’s pivotal (505(b)(2)) bioequivalence study yielded a clean (positive) read-out in Jun. 2022 — in an area of significant unmet need,” writes analyst Rahul Sarugaser.
“Should ALPHA-1062 be approved, it would make the drug only the 9th ever to receive approval for AD, and only the 2nd drug approved this decade (aduhelm notwithstanding, which was approved but failed to garner reimbursement), following BIIB’s lecanemab, which is expected to hit multi-blockbuster status,” said Dr. Sarugaser.
In addition, he said if approved, ALPHA-1062, which is symptom-modifying, could be used in concert with lecanemab, which is disease-modifying, “suggesting that ALPHA-1062 could ride the coattails of lecanamab’s anticipated success.”
