Biogen ALS Drug Receives Backing of FDA Panel in 9-0 Vote, FDA Says Tofersen Likely to Predict Benefit
Biogen (BIIB) ALS Drug Receives Backing of FDA Panel in 9-0 Vote, FDA Says Tofersen Likely to Predict Benefit
Strong Buy
or
Biogen News & Analysis
-
-
Analysts positive on Biogen after FDA posts docs ahead of advisory panel for Tofersen
By Davit Kirakosyan FDA posted documents yesterday ahead of the advisory panel for Biogen's (NASDAQ:BIIB) Tofersen for ALS. Needham believes these documents strike a favorable tone and the...
-
Despite Failed Phase 3 Study, FDA Staff Says Biogen's ALS Drug May Have Clinical Benefit
FDA's Peripheral and Central Nervous System Drugs Advisory Committee will virtually meet on Wednesday, March 22, to discuss Biogen Inc's (NASDAQ: BIIB) ALS drug tofersen. FDA staff, citing a...
-
FDA Posts Documents Ahead of Advisory Panel for Biogen's Tofersen for ALS
FDA Posts Documents Ahead of Advisory Panel for Biogen's (BIIB) Tofersen for ALS...
-
Biogen Triumphs In Legal Battle Regarding Tecfidera, Delaying EU Generic Erosion For Another Year
The Court of Justice of the European Union favored Biogen Inc (NASDAQ: BIIB) regarding its appeal of a General Court decision annulling the European Medicines Agency's (EMA) refusal to...
-
Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European...
-
Analyst Says Biogen-Eisai's Alzheimer's Treatment Leqembi Coverage Enables Access To Over $2.5B Market Opportunity
Eisai Co Ltd (OTC: ESALY) and Biogen Inc (NASDAQ: BIIB) said the U.S. Department of Veteran Affairs (VA) would provide coverage of their Alzheimer's treatment Leqembi (lecanemab) to veterans...
-
: Veterans Health to cover Eisai, Biogen’s new Alzheimer’s drug
Eisai Co. Ltd. JP:4523 said Tuesday that the Veterans Health Administration will cover Leqembi, the Alzheimer’s disease treatment it developed with Biogen Inc. BIIB that received an...
-
Eisai, Biogen Alzheimer's Leqembi To Get Some Va Coverage - Bloomberg
Eisai, Biogen (NASDAQ:BIIB) Alzheimer's Leqembi To Get Some Va Coverage - Bloomberg
-
Biogen Announces Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Board of Directors
Biogen Inc. (NASDAQ:BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual...
-
Eisai, Biogen announced FDA accepts sBLA for LEQEMBI
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's supplemental Biologics License Application (sBLA) for...
-
Eisai-Biogen Seek Complete FDA Approval For Its Second Alzheimer's Treatment
The FDA has accepted Eisai Co Ltd (OTC: ESALY) and Biogen Inc's (NASDAQ: BIIB) supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection, supporting...
-
Biogen tops Q4 analyst estimate, guidance mixed
By Senad Karaahmetovic Biogen (NASDAQ:BIIB) reported better-than-expected fourth-quarter results to see its shares trade modestly higher in pre-market Wednesday. The company reported Q4...
-
Airbnb, TripAdvisor, Tesla rise premarket; Barclays, Devon Energy fall
By Peter Nurse Investing.com -- Stocks in focus in premarket trade on Wednesday, February 15th. Please refresh for updates. Airbnb (NASDAQ:ABNB) stock rose 8.4% after the house rental firm...
-
U.S. stock futures drift lower ahead of retail sales, fresh corporate earnings
By Scott Kanowsky Investing.com -- U.S. stock futures pointed broadly lower on Wednesday, as investors looked ahead to fresh retail sales data and a new slate of corporate results. At 07:16...
-
Biogen Tops Q4 EPS by 57c, Offers Guidance
Biogen (NASDAQ:BIIB) reported Q4 EPS of $4.05, $0.57 better than the analyst estimate of $3.48. Revenue for the quarter came in at $2.54 billion versus the consensus estimate of $2.44...
-
Biogen earnings beat by $0.57, revenue topped estimates
Investing.com - Biogen (NASDAQ: BIIB) reported fourth quarter EPS of $4.05, $0.57 better than the analyst estimate of $3.48. Revenue for the quarter came in at $2.54B versus the consensus...
-
Fedspeak, U.S. retail sales, U.K. inflation, Apple stake - what's moving markets
By Peter Nurse Investing.com -- The U.S. consumer price report has caused a rethink of the level at which the Federal Reserve will stop its interest rate hikes, and Wall Street is set to...
-
Dow Jones, Nasdaq, S&P 500 weekly preview: Use Q1 rally to cut stocks exposure
By Senad Karaahmetovic The U.S. equities moved lower last week as investors await tomorrow’s CPI release and continue to digest remarks from Federal Reserve policymakers. The S&P...
-
Flying objects, Adani, EU recession, U.S. CPI, Crude - what's moving markets
By Peter Nurse Investing.com -- The U.S. Air Force continues to shoot down unexplained flying objects over North America, while beleaguered Indian conglomerate Adani plans to reduce capital...
-
Top 5 things to watch in markets in the week ahead
By Noreen Burke Investing.com -- Investors will be closely watching Tuesday's U.S. inflation data for clarity on the Federal Reserve’s rate hike path. Earnings season is winding down...
-
Sage Therapeutics-Biogen Partnered Depression Candidate Under Priority FDA Review, Analyst Says Its 'Incrementally Positive'
The FDA has accepted for review a marketing application seeking approval for Sage Therapeutics Inc (NASDAQ: SAGE) and Biogen Inc's (NASDAQ: BIIB) zuranolone for major depressive disorder...
-
Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and postpartum depression (PPD) Depression is a public...
-
Biogen gains as analysts reflect positively on Leqembi's approval, pricing
By Senad Karaahmetovic On Friday, the United States Food and Drug Administration (FDA) officially approved Leqembi, a new drug developed by Biogen (NASDAQ:BIIB) and Japan-based Eisai...
-
Eisai, Biogen Alzheimer drug granted FDA accelerated approval
By Sam Boughedda On Friday, the U.S. Food and Drug Administration approved lecanemab, the Alzheimer's drug developed by Eisai Co (OTC:ESALY) and Biogen (NASDAQ:BIIB) for patients in the...
-
For Lecanemab, a $25k to $30k annual price 'could still be appropriate' - Wells Fargo
By Sam Boughedda Wells Fargo analysts said in a note on biotechnology stocks on Friday that for Biogen (NASDAQ:BIIB), a $25,000 to $30,000 annual price could still be appropriate for...
-
Analysts impressed by Biogen after full data on Alzheimer's drug Lecanemab
By Senad Karaahmetovic Biogen (NASDAQ:BIIB) yesterday presented detailed results from the Ph3 Clarity AD confirmatory trial. According to the company, Lecanemab "reduced markers of amyloid...
-
Workday, Boeing, Tesla and Airbnb rise premarket; Crowdstrike falls
By Peter Nurse Investing.com -- Stocks in focus in premarket trade on Wednesday, November 30th. Please refresh for updates. Crowdstrike (NASDAQ:CRWD) stock slumped 17% after the...
-
Midday movers: Wynn Resorts, Biogen, Apple and more
By Liz Moyer Investing.com -- Stocks were falling as protests in China over the government's strict COVID-19 lockdown rules sparked fears of a global growth slowdown. Here are the midday...
-
Biogen stock falls on Alzheimer's drug trial death reports
By Sam Boughedda Biogen (NASDAQ:BIIB) shares dipped Monday after a report by Science.org stated that a woman participating in a trial of experimental Alzheimer's treatment lecanemab had...
-
Apple, Chevron, Biogen fall premarket; Univar, Pinduoduo rise
By Peter Nurse Investing.com -- Stocks in focus in premarket trade on Monday, November 28th. Please refresh for updates. Apple (NASDAQ:AAPL) stock fell 1.8% after a report indicated the...
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures), cryptocurrencies, and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn't bear any responsibility for any trading losses you might incur as a result of using this data. Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
