Workflow
Biogen(BIIB)
icon
Search documents
Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS
Newsfilter· 2024-05-30 20:51
SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS estimated to affect less than 1,000 people in Europe1QALSODY is Biogen's third rare disease therapy to be approved in the EU, demonstrating the company's commitment to addressing diseases with a high unmet needWith QALSODY, Biogen has helped advance neurofilament as a tool to optimize clinical trial design in ALS, offering the potential to expedite further breakthroughs in the field CAMBRIDGE, Mass., May 30, 2024 (GLOBE NEWSWIRE) ...
Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS
GlobeNewswire News Room· 2024-05-30 20:51
SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS estimated to affect less than 1,000 people in Europe1QALSODY is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment to addressing diseases with a high unmet needWith QALSODY, Biogen has helped advance neurofilament as a tool to optimize clinical trial design in ALS, offering the potential to expedite further breakthroughs in the field CAMBRIDGE, Mass., May 30, 2024 (GLOBE NEWSWIRE) ...
Jeito Capital announces the acquisition by Merck & Co (NYSE: MRK) of its portfolio company EyeBio for a potential value of $3 billion
Newsfilter· 2024-05-29 11:02
Jeito Capital announces the acquisition by Merck & Co (NYSE:MRK)of its portfolio company EyeBio for a potential value of $3 billion This acquisition reflects the significant clinical progress achieved with Restoret™, EyeBio's novel late-phase candidate for diabetic macular edema, as well as a preclinical pipeline targeting retinal diseases - Restoret anticipated to enter pivotal study for diabetic macular edema in the second half of 2024 The acquisition by Merck & Co (NYSE:MRK), a global biopharmaceutical c ...
Why Is Biogen (BIIB) Up 7.7% Since Last Earnings Report?
zacks.com· 2024-05-24 16:39
Earnings Performance - Biogen reported Q1 2024 adjusted EPS of $3.67, beating the Zacks Consensus Estimate of $3.45, representing an 8% YoY increase driven by cost savings and margin improvements [2] - Total revenues were $2.29 billion, down 7% YoY on both reported and constant-currency basis, missing the Zacks Consensus Estimate of $2.32 billion [2] - Product sales declined 3% YoY to $1.71 billion, with anti-CD20 therapeutic programs revenues down 1% to $394.0 million [2] Key Product Performance - MS revenues declined 4% YoY to $1.08 billion due to generic competition for Tecfidera and rising competitive pressure [4] - Tecfidera sales declined 7.4% to $254.3 million but beat estimates, with EU market protection extended until February 2025 [4] - Vumerity sales increased 18% to $127.5 million, while Tysabri sales declined 9% to $431.3 million [5] - Spinraza sales declined 23% to $341.3 million, with U.S. sales up 1% but ex-U.S. sales down 35% [7] - Skyclarys generated $78.0 million in sales, with 1,100 patients on therapy in the U.S. and 300 in Europe [8] New Product Launches - Leqembi sales nearly tripled sequentially to $19 million in Q1 2024, with patient numbers increasing 2.5 times since 2023-end [3] - Biogen plans to expand its U.S. salesforce by 30% to promote Leqembi as patient volume accelerates [3] - Qalsody recorded $4.6 million in sales, showing encouraging uptake for ALS treatment [8] Cost Management - R&D expenses declined 22% YoY to $447 million, while adjusted SG&A expenses declined 6% to $569 million [10] - Collaboration profit-sharing was a net expense of $66 million, including $61 million related to biosimilar collaboration with Samsung Bioepis [10] Financial Position - No shares were repurchased in Q1 2024, with $2.1 billion remaining under the $5 billion share buyback plan authorized in October 2020 [11] 2024 Guidance - Total revenues expected to decline by low-to mid-single-digit percentage in 2024 [12] - Core pharmaceutical revenues expected to be flat in 2024, with MS revenue declines offset by new product growth [13] - Adjusted EPS expected in the range of $15.00 to $16.00, implying ~5% growth at midpoint [13] - Combined R&D and SG&A expenses expected to be ~$4.3 billion in 2024 [13] - Operating income expected to grow at low-double-digit percentage, with operating margin increasing by mid-single-digit percentage points [13]
BIIB INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Biogen Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit!
prnewswire.com· 2024-05-24 03:28
NEW YORK, May 23, 2024 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Biogen Inc. ("Biogen Inc." or "the Company") (NASDAQ: BIIB) and certain of its officers.Class Definition:This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Biogen Inc. securi ...
SHAREHOLDER ACTION ALERT: The Schall Law Firm Encourages Investors in Biogen Inc. with Losses to Contact the Firm
prnewswire.com· 2024-05-23 22:52
LOS ANGELES, May 23, 2024 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Biogen Inc. ("Biogen" or "the Company") (NASDAQ: BIIB) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between February 3, 2022 and February 13, 2024, inclusive (the "Class Period"), are en ...
Biogen (BIIB) to Buy HI-Bio to Expand Rare Disease Pipeline
zacks.com· 2024-05-23 15:11
Biogen (BIIB) entered into a definitive agreement to acquire private biotech, HI-Bio, for a $1.15 billion upfront payment.The acquisition will expand Biogen’s rare disease pipeline by adding Hi-Bio’s lead candidate, felzartamab, a promising late-stage ready asset with potential application across a range of rare immune-mediated diseases. Felzartamab, a fully human anti-CD38 monoclonal antibody, has demonstrated an impact on key biomarkers and clinical endpoints in three renal diseases.Felzartamab is being d ...
Biogen Buys Biotech Firm HI-Bio to Boost Its Immunology Portfolio
investopedia.com· 2024-05-23 00:00
Key TakeawaysBiogen has agreed to pay at least $1.15 billion for biotech firm Human Immunology Biosciences (HI-Bio) as it moves to increase its immunology portfolio.The deal includes the possibility of an additional $650 million in milestone payments. HI-Bio's lead asset treats rare kidney diseases. Biogen (BIIB) announced Wednesday it had purchased privately-held Human Immunology Biosciences (HI-Bio) for at least $1.15 billion to expand its reach into immunology medicines.  The company said that the $1.15 ...
Pomerantz Law Firm Announces the Filing of a Class Action Against Biogen Inc. and Certain Officers - BIIB
prnewswire.com· 2024-05-22 23:30
NEW YORK, May 22, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Biogen Inc. ("Biogen" or the"Company") (NASDAQ: BIIB) and certain officers. The class action, filed in the United States District Court for the District of Colorado, and docketed under 24-cv-01444, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Biogen securities between February 3, 2022 and February 13, 2024, both dates i ...
Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences
Newsfilter· 2024-05-22 11:30
Transaction to include felzartamab, a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseasesFelzartamab is an investigational anti-CD38 monoclonal antibody that, through its cell depletion approach, has demonstrated clinical proof of concept in rare immune-mediated indications, with plans to advance to Phase 3Proposed acquisition builds on Biogen capabilities in immunology with plans to combine Human Immunology Biosciences expertise ...