Eisai shares 4523, +9.14% rose sharply Thursday morning after the U.S. Food and Drug Administration’s review memo on Leqembi raised expectations for full approval of the Alzheimer’s drug.
The shares were recently 9.0% higher at 10,465 yen ($74.67) after rising as much as 10% earlier.
The FDA on Wednesday released the briefing document ahead of a public-advisory committee hearing on Friday. The U.S. agency called the meeting to gather advice from outside experts on whether to grant full approval to the drug, which was cleared conditionally in January.
Jefferies analysts said in a research note that they didn’t see the advisory committee as a high-risk event, particularly after viewing the briefing document, which seemed supportive of approval.
The analysts said that while key safety-related topics for discussion included use of the drug in patients that might suffer from a higher risk of side effects, these concerns were well understood by investors, and they didn’t think that these issues would stand in the way of a positive vote.