Day: June 9, 2024

FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

Written by Customer Service on . Posted in Public Companies.

TOKYO and CAMBRIDGE, Mass., June 09, 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 the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD). As part of the proposed monthly IV maintenance regimen, the patients who have completed the...

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REPEAT – EnviroGold Global Closes First Tranche of Private Placement

REPEAT – EnviroGold Global Closes First Tranche of Private Placement

Written by Customer Service on . Posted in Public Companies.

TORONTO, June 09, 2024 (GLOBE NEWSWIRE) — EnviroGold Global Limited (CSE: NVRO | OTCQB: ESGLF | FSE: YGK) (“EnviroGold,” or the “Company”), a technology company enabling the global mining industry to monetize valuable metals contained in mine waste and tailings, reduce environmental liabilities and improve social and environmental outcomes, is pleased to announce that it has closed the first tranche of the previously announced non-brokered private placement and issued 14,600,000 units (the “Units”) at a price of $0.05 per Unit for aggregate proceeds of C$730,000 (the “Financing”). Each Unit consists of one common share (each a “Common Share”) and one warrant (each a “Warrant”) exercisable to acquire one additional Common Share at a price of $0.08 until April 30, 2026. The Company anticipates closing a second tranche of the Financing...

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