Previous close | 5.34 |
Open | 2.70 |
Bid | 0.00 |
Ask | 10.00 |
Strike | 135.00 |
Expiry date | 2025-06-20 |
Day's range | 2.70 - 5.34 |
Contract range | N/A |
Volume | |
Open interest | 8 |
Biogen (BIIB) and Eisai start the rolling submission of a biologics license application to the FDA for Leqembi subcutaneous autoinjector as a weekly maintenance dosing regimen for early Alzheimer's disease.
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