ESALF News and Press, Eisai Co Ltd From 01/29/21

Today, Biogen ([[BIIB]] +10.1%) and Eisai's ([[ESALF]]) announced that FDA has extended the review period for aducanumab by three months, sending the Biogen shares 10% higher in premarket trading.In a note to clients, the analysts at Stifel comment that with the extension of the review period...

The FDA has extended the review period by three months for Biogen (BIIB) and Eisai's (ESALF) Biologics License Application ((BLA)) for aducanumab, an investigational treatment for Alzheimer’s disease.The updated PDUFA action date is June 7, 2021. Biogen submitted a response to an infor...

Merck (MRK) and Eisai (ESALF) have announced data demonstrating positive top-line results from Phase 3 KEYNOTE-775/Study 309, evaluating Merck's Keytruda plus Eisai's Lenvima in patients with advanced endometrial cancer following at least one prior platinum-based regimen.The study met it...

Biogen (BIIB) has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare ((MHLW)) for aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease. The Japanese regulatory authority will review the application through the standard rev...

Merck (MRK) and Eisai (ESALF) announce new investigational data demonstrating positive top-line results from the Phase 3 KEYNOTE-581/CLEAR trial (Study 307).In the trial, the combinations of Merck's Keytruda plus Eisai's Lenvima and Lenvima plus everolimus were evaluated versus Sunitinib...

Eisai Co., Ltd. (ESALF) Q2 2021 Earnings Conference Call November 5, 2020 02:00 AM ET Company Participants Ryohei Yanagi - Chief Financial Officer Ivan Cheung - Senior VP & President of Neurology Business Group Terushige Iike - Senior VP & President of Oncology Business Group Takashi ...

The following slide deck was published by Eisai Co., Ltd. in conjunction with their 2021 Q2 earnings call. For further details see: Eisai Co., Ltd. 2021 Q2 - Results - Earnings Call Presentation

Japan's Ministry of Health, Labor and Welfare has approve Gilead's (GILD) Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of rheumatoid arthritis ((RA)) who did not respond to conventional therapies.Gilead will hold the mark...

Sell-side analysts are generally bullish on an FDA nod on Biogen's ( BIIB +8.8% ) Alzheimer's disease (AD) med aducanumab. This morning, the company announced that the agency accepted its marketing application under Priority Review status with a March 7, 2021 action date. More news on:...

Eisai Co Ltd (ESALF) Q1 2021 Earnings Conference Call August 03, 2020 03:00 AM ET Company Participants Ryohei Yanagi - Chief Financial Officer Ivan Cheung - Senior VP & President of Neurology Business Group Terushige Iike - Senior VP & President of Oncology Business Gro...