FDA Approval for VUMERITY issued to BIOGEN INC
$BIIB
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 1/7/2026 | $185.00 | Neutral | UBS |
| 12/10/2025 | $143.00 | Hold → Reduce | HSBC Securities |
| 11/6/2025 | $202.00 | Hold → Buy | Stifel |
| 9/25/2025 | $190.00 | Buy | Jefferies |
| 7/21/2025 | $142.00 | Hold | Truist |
| 4/28/2025 | $118.00 | Buy → Hold | HSBC Securities |
| 4/4/2025 | Buy → Hold | Argus | |
| 2/11/2025 | $160.00 | Mkt Perform | Bernstein |
Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activityLitifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurementFDA Breakthrough Therapy Designation is granted to expedite the development and review of drugs for serious diseases CAMBRIDGE, Mass., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) – announced today that the U.S. Food and D
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease FDA action date set for May 24, 2026 TOKYO and CAMBRIDGE, Mass., Jan. 25, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen"), Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ", Biogen", ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's Supplemental Biologics License A
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease FDA action date set for May 24, 2026 TOKYO and CAMBRIDGE, Mass., Jan. 25, 2026 (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 U.S. Food and Drug Administration (FDA) has accepted for review Eisai's Supplemental Biologics License Application (sBLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinject
SCHEDULE 13G/A - BIOGEN INC. (0000875045) (Subject)
SCHEDULE 13G - BIOGEN INC. (0000875045) (Subject)
10-Q - BIOGEN INC. (0000875045) (Filer)
Submission status for BIOGEN INC's drug VUMERITY (ORIG-1) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 09/12/2024. Application Category: NDA, Application Number: 761347, Application Classification: Type 3 - New Dosage Form
Submission status for BIOGEN INC's drug VUMERITY (SUPPL-17) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 09/11/2024. Application Category: NDA, Application Number: 211855, Application Classification: Manufacturing (CMC)
Submission status for BIOGEN INC's drug VUMERITY (SUPPL-15) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 03/22/2024. Application Category: NDA, Application Number: 211855, Application Classification: Labeling
UBS resumed coverage of Biogen with a rating of Neutral and set a new price target of $185.00
HSBC Securities downgraded Biogen from Hold to Reduce and set a new price target of $143.00
Stifel upgraded Biogen from Hold to Buy and set a new price target of $202.00
4 - BIOGEN INC. (0000875045) (Issuer)
4 - BIOGEN INC. (0000875045) (Issuer)
4 - BIOGEN INC. (0000875045) (Issuer)
4 - BIOGEN INC. (0000875045) (Issuer)
4 - BIOGEN INC. (0000875045) (Issuer)
In the news release, Global Leaders Jesús Mantas and Wes Bricker Join NACD Board of Directors, issued 10-Oct-2025 by National Association of Corporate Directors over PR Newswire, we are advised by the company that the third paragraph, the end of the last line, should read "IBM Business Transformation Services" instead of "IBM Consulting Business Transformation Services" as originally issued inadvertently. The complete, corrected release follows: Global Leaders Jesús Mantas and Wes Bricker Join NACD Board of Directors Seasoned executives bring deep expertise in innovation, governance, and business to strengthen NACD's leadership board excellence WASHINGTON, Oct. 10, 2025 /PRNewswire/ -- Th
Seasoned executives bring deep expertise in innovation, governance, and business to strengthen NACD's leadership board excellence WASHINGTON, Oct. 10, 2025 /PRNewswire/ -- The National Association of Corporate Directors® (NACD®) today announced the appointment of Jesús Mantas, recently retired Global Leader of IBM Business Consulting, and Wes Bricker, Global Assurance Leader at PwC, to its board of directors, effective immediately. The appointments bring to NACD a wealth of experience spanning technology, innovation, assurance, governance and capital markets — further strengthening the association's ability to guide directors as they navigate today's rapidly evolving business landscape. Mant
BOSTON, June 03, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (NASDAQ:TRDA) today announced the appointment of Maha Radhakrishnan, M.D., to its Board of Directors. "We are pleased to have Dr. Radhakrishnan join the Board at this time of tremendous clinical momentum at Entrada, led by the continued advancement of our Duchenne muscular dystrophy franchise. Dr. Radhakrishnan's deep and meaningful experience in global drug development will be invaluable as we quickly advance our novel Duchenne programs into multiple patient-focused clinical trials throughout this year," said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. "I'm honored to join the Board of Entrada
NEW YORK, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Nasdaq (NASDAQ:NDAQ) today announced the results of the annual reconstitution of the Nasdaq-100 Index® (NDX®), which will become effective prior to market open on Monday, December 22, 2025. The following six companies will be added to the Index: Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), Ferrovial SE (NASDAQ:FER), Insmed Incorporated (NASDAQ:INSM), Monolithic Power Systems, Inc. (NASDAQ:MPWR), Seagate Technology Holdings plc (NASDAQ:STX), Western Digital Corp. (NASDAQ:WDC). The Nasdaq-100 Index is a globally recognized index that tracks the performance of 100 of the largest non-financial companies listed on the Nasdaq Stock Market® encompassi
CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) has completed the acquisition of Alcyone Therapeutics, a clinical-stage biotechnology company known for its innovative CNS therapy delivery solutions, such as the ThecaFlex DRx™ drug delivery system. ThecaFlex DRx™ is an investigational implantable device designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of medicines, which could ease both patient experience and accessibility for a broader population of people living with neurologic disorders. ThecaFlex DRx™ has been in development since 2019, with the PIERRE and PIERRE-PK clinical studies for nusinersen curren
Dapirolizumab pegol (DZP) Phase 3 study presentations in SLE to show efficacy results across multiple clinical endpoints, including low disease activity/remission, flares, fatigue, joint pain and quality of lifePresentation of preclinical study of DZP showing minimal to no human placental transfer CAMBRIDGE, Mass., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced upcoming presentations from studies evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, in systemic lupus erythematosus (SLE) to be presented at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) in Chicago, Illinois. The presentations will show effi
SC 13G/A - BIOGEN INC. (0000875045) (Subject)
SC 13G/A - BIOGEN INC. (0000875045) (Subject)
SC 13G - BIOGEN INC. (0000875045) (Subject)