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BIIB Jun 2025 165.000 put
| Previous close | 6.90 |
| Open | 6.90 |
| Bid | 0.15 |
| Ask | 9.20 |
| Strike | 165.00 |
| Expiry date | 2025-06-20 |
| Day's range | 6.90 - 6.90 |
| Contract range | N/A |
| Volume | |
| Open interest | 9 |
- Reuters
UPDATE 1-Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA
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.
GlobeNewswireEisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Under the Fast Track Status
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
- Reuters
Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA
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.
