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2023-05-01 08:47:05 ET After three straight sessions of gains, Biogen ( NASDAQ: BIIB ) shares continued to rise in the pre-market Monday as Guggenheim upgraded the biotech citing full FDA approval for its Alzheimer's therapy Leqembi developed with Eisai ( OTCPK:ESALF )( OTCPK:...
2023-04-26 11:32:44 ET Eli Lilly ( NYSE: LLY ) is expected to report its Q1 2023 results before the opening bell on Thursday for a market on the lookout for updates on its pipeline led by Alzheimer’s candidate donanemab and weight loss agent tirzepatide. Amid waning deman...
2023-04-25 08:01:00 ET Biogen ( NASDAQ: BIIB ) stock is trading in the red premarket Tuesday after the company said it is discontinuing certain drug programs amid reporting its Q1 results, which beat estimates. Biogen said it will terminate its involvement in developing BI...
2023-04-06 12:35:54 ET FDA’s accelerated drug approval program came under scrutiny on Thursday after the agency withdrew its approval for Makena, a drug first cleared the regulatory hurdle more than a decade ago to prevent preterm birth in women. The FDA approved Makena in 2011 u...
2023-04-03 07:05:32 ET The U.S. National Institute on Aging (NIA) is funding an up to $300M project to create a research database for Alzheimer's disease (AD) which can track Americans' health for many years and help researchers to get insights on AD, Reuters reported. The NIA plan...
2023-03-14 05:42:41 ET Medivir ( OTC:MVRBF ) said the first patient with liver cancer started treatment with its drug fostroxacitabine bralpamide (fostrox) in combination with Eisai's ( OTCPK:ESALF ) ( OTCPK:ESAIY ) Lenvima in phase 2a trial. In the Swedish c...
2023-03-06 04:34:16 ET The U.S. Food and Drug Administration (FDA) granted priority review to Biogen's ( NASDAQ: BIIB ) application seeking traditional approval of Alzheimer's disease (AD) therapy Leqembi (lecanemab) from its current status of accelerated approval. ...
Reata Pharmaceuticals ( NASDAQ: RETA ) lost ~32% on Monday to reach the lowest level in over four months as a key FDA official leaves the agency while the company awaits the U.S. approval for its Friedreich's ataxia ((F.A.)) therapy, omaveloxolone. Earlier in the day, multiple new...
Summary Growth in Japan markets the standout for the period, with growth across all core segments. Leqembi gaining substantial traction in regulatory approvals in key global markets. Hence therein lies a strong investment opportunity with ESALF for those seeking exposure to breakthr...
The U.S. CEO of Eisai ( OTCPK:ESALY ) said that the U.S. FDA could grant full approval of its Alzheimer's treatment Leqembi (lecanemab) as soon as July. Speaking with CNBC, Ivan Cheung said, "We’re literally talking about maybe like five months away, so we are moving with urgency d...
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"LEQEMBI" Lecanemab) Approved for the Treatment of Alzheimer's Disease in Israel TOKYO and CAMBRIDGE, Mass., July 12, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMB...
"LEQEMBI" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Hong Kong TOKYO and CAMBRIDGE, Mass., July 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Department of Health in HongKong has approved humanized anti-soluble aggregated ...
Eisai Announces Move to Solo Development and Commercialization of Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate (ADC) TOKYO, July 2, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has agreed to end its global strategic collaboration with Bristol Myers Squi...