Previous close | 29.00 |
Open | 35.26 |
Bid | 36.40 |
Ask | 40.00 |
Strike | 210.00 |
Expiry date | 2024-10-18 |
Day's range | 35.26 - 35.26 |
Contract range | N/A |
Volume | |
Open interest | 166 |
Eisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing application of a subcutaneous form of their Alzheimer's disease drug Leqembi. The companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of Leqembi to be given as an under-the-skin injection. Under a rolling submission the regulator assesses the data as and when it becomes available, and the process continues until there is enough data for a formal marketing application.
TOKYO and CAMBRIDGE, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dos
Eisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing application of a subcutaneous form of their Alzheimer's disease drug Leqembi. The companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of Leqembi to be given as an under-the-skin injection. Eisai in April delayed filing for marketing approval of the subcutaneous form of Leqembi, as the FDA had requested for additional three-month immunogenicity data.