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Biogen(BIIB) - 2024 Q2 - Quarterly Results
2024-08-01 10:55
Press Release Cambridge, Mass. – Aug. 1, 2024 Biogen reports strong second quarter 2024 results and raises full year 2024 financial guidance; Second quarter 2024 total revenue of $2.5 billion, GAAP diluted EPS of $4.00 and Non-GAAP diluted EPS of $5.28 Second quarter total revenue was flat at actual currency and up 1% at constant currency, with GAAP diluted EPS decline of 2% and Non-GAAP diluted EPS increase of 31% year-over-year • Core pharmaceutical revenue (product revenue + LEQEMBI) up 5% at actual curr ...
Alcyone Therapeutics Announces Continued Enrollment Approval from FDA of the PIERRE Pivotal IDE Clinical Study of the ThecaFlex DRx™ System for Administration of nusinersen
Prnewswire· 2024-07-31 13:00
Alcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF). The first stage of the pivotal IDE PIERRE trial has been completed. 10 spinal muscular atrophy (SMA) patients have undergone ThecaFlex implantation and have received nusinersen through the device. No device-related adverse events, including infections, were observed in the 30 days after implantation. FDA has agreed to an additional 80-SMA patient ...
Watch These 5 Biotech Stocks for Q2 Earnings: Beat or Miss?
ZACKS· 2024-07-30 18:35
The second-quarter 2024 reporting cycle of the Medical sector will gain further traction this week. The sector mainly comprises pharma/biotech and medical device companies.The earnings season for the sector kicked off earlier this month, when bellwether Johnson & Johnson reported strong second-quarter results, beating on both counts. Swiss pharma giant Novartis AG also reported better-than-expected quarterly results. Last week, biotech giant Bristol-Myers also beat on its sales and earnings.Per the Earnings ...
Countdown to Biogen (BIIB) Q2 Earnings: A Look at Estimates Beyond Revenue and EPS
ZACKS· 2024-07-30 14:21
Wall Street analysts forecast that Biogen Inc. (BIIB) will report quarterly earnings of $4 per share in its upcoming release, pointing to a year-over-year decline of 0.5%. It is anticipated that revenues will amount to $2.38 billion, exhibiting a decline of 3.1% compared to the year-ago quarter.The consensus EPS estimate for the quarter has been revised 0.3% lower over the last 30 days to the current level. This reflects how the analysts covering the stock have collectively reevaluated their initial estimat ...
Biogen, Beckman Coulter and Fujirebio to Collaborate on Blood-Based Biomarkers and Test for Tau Pathology in Alzheimer's Disease
Newsfilter· 2024-07-30 11:30
The collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brainThese tools have the potential to be used to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer's disease CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to potentially identify ...
Biogen, Beckman Coulter and Fujirebio to Collaborate on Blood-Based Biomarkers and Test for Tau Pathology in Alzheimer's Disease
GlobeNewswire News Room· 2024-07-30 11:30
The collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brainThese tools have the potential to be used to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer’s disease CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to potentially identif ...
What Awaits Biogen (BIIB) in Q2 Earnings Post Leqembi Setback?
ZACKS· 2024-07-29 15:35
Biogen (BIIB) , due to report second-quarter 2024 results on Aug 1, suffered a setback recently. Biogen and its Japanese partner Eisai on Friday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a negative opinion regarding marketing approval for their anti-amyloid beta therapy, Leqembi (lecanemab) for early Alzheimer’s disease in Europe. The CHMP’s negative opinion was reportedly due to a brain swelling side effect called amyloid-related im ...
Europe Just Turned Down Biogen's Alzheimer's Drug. Is the Stock One to Avoid, or a Bad News Buy?
The Motley Fool· 2024-07-29 09:30
Biogen stock has slipped 18% so far this year.Biogen (BIIB -7.15%) built itself into a multiple sclerosis (MS) treatment giant over the years -- but as older blockbusters lost exclusivity, growth stalled. And last year, annual revenue dropped more than 45% to $9.8 billion from its peak back in 2019. Though Biogen launched a new MS drug back in 2019, called Vumerity, it's failed to replicate the growth and revenue levels of its predecessor.To boost growth, Biogen turned to other areas, and has placed a parti ...
European drug regulator rejects Alzheimer's treatment Leqembi from Biogen, Eisai
CNBC· 2024-07-26 12:42
European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai, creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. The European Commission, the EU's executive body, has a final say in Leqembi's approval. But it almost always follows the drug regulator's recommendations. In a statement, Eisai said it is "extremely disappointed" by the regulator's negative recommendation. The company added that it will seek a re-examinatio ...
Update on Regulatory Review of Lecanemab for Early Alzheimer's Disease in the European Union
Newsfilter· 2024-07-26 11:20
TOKYO and CAMBRIDGE, Mass., July 26, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monocl ...