$BIIB News

Last published 3d ago

3d agoBIIBACR 2026: Dapirolizumab Pegol Associated with Greater Treatment Response Rates Versus Placebo in SLE Using Novel Treatment Response MeasureGlobeNewswireDapirolizumab pegol (DZP) associated with higher response rates using the novel Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE): A...
3d agoBIIBACR 2026: Dapirolizumab Pegol Associated with Greater Treatment Response Rates Versus Placebo in SLE Using Novel Treatment Response MeasureGlobeNewswireDapirolizumab pegol (DZP) associated with higher response rates using the novel Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE): A post-hoc analysis applying TRM-SLE to the DZP Phase 3 PHOENYCS GO
1w agoSTOK BIIBStoke Therapeutics Announces Third Quarter 2026 Financial Results and Provides Business UpdatesBusiness Wire–Phase 3 EMPEROR study of zorevunersen, an investigational medicine for Dravet syndrome: ~110 patients through Week 28 primary endpoint, ~20 patients through Week 52 and all continuing into open-label treatment period;
1w agoBIIBBiogen to Present New Data Across Alzheimer's Disease Portfolio at CTAD 2026GlobeNewswireDiranersen late-breaking symposium will feature 96-week long-term extension data and additional 76-week biomarker and clinical data from the Phase 2 CELIA study in early Alzheimer's diseaseLecanemab presentations
2w agoBIIBBIOGEN INC. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
2w agoSTOK BIIBStoke Therapeutics to Host Webcast and Conference Call to Discuss Third Quarter 2026 Business and Financial UpdatesBusiness WireStoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in
3w agoBIIBBiogen to Present New Data Across Nephrology Portfolio, Including Long-term EMPAVELI® (pegcetacoplan) Phase 3 Results, at American Society of Nephrology (ASN) Kidney WeekGlobeNewswireTwo oral presentations to highlight new 76-week data showing sustained proteinuria reduction and continued eGFR stabilization with a consistent long-term safety profileAdditional presentations to highlight nephrologist
1mo agoSTOK BIIBStoke Therapeutics Announces Completion of Successful Meeting with the FDA to Align on Planned U.S. NDA for Zorevunersen, an Investigational Medicine for the Treatment of Dravet SyndromeBusiness Wire– Analysis of the Phase 3 EMPEROR key secondary endpoint of changes in cognition and behavior will be performed using a multicomponent assessment of four Vineland-3 subdomains – – Phase 3 readout anticipated in the
1mo agoSTOK BIIBStoke Therapeutics Appoints Bo Cumbo to its Board of Directors, Enhancing Commercial Expertise as the Company Advances Zorevunersen Development Toward Potential FDA Approval and CommercializationBusiness Wire–Mr. Cumbo brings deep experience commercializing new medicines for people with rare genetic diseases– –Company announces retirement of Director Edward Kaye, M.D., from the Board– Stoke Therapeutics, Inc.
1mo agoBIIBPhase 3 Pediatric EMPAVELI Data Published in Clinical Journal of the American Society of Nephrology Show Reduction in Proteinuria and Stabilized Kidney Function in Adolescents with C3G or Primary IC-MPGNGlobeNewswireEMPAVELI-treated adolescents achieved a 75% relative reduction in proteinuria within 6 months versus placebo EMPAVELI is the only approved treatment for adolescents with C3G and primary IC-MPGN, based on VALIANT
1mo agoBIIBLEQEMBI® Pen (Subcutaneous Formulation of LEQEMBI®) Approved in Japan for the Treatment of Early Alzheimer’s DiseaseGlobeNewswireTOKYO and CAMBRIDGE, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB), announced today that "LEQEMBI® Pen", the subcutaneous (SC) formulation of the anti-amyloid beta
2mo agoQNTM SNY RHHBY BIIB+1A Micro-Cap Biotech Just Cleared a Milestone Most Never ReachGlobeNewswireAUSTIN, Texas, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis ("MS") drugs on the market today can slow the disease down, but none of them stop it, and none of them give
2mo agoBIIB STOKStoke Therapeutics and Biogen Present Long-Term Clinical Data that Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)GlobeNewswire–4-year data from the Phase 1/2a open-label extension (OLE) studies showed substantial and durable reductions in seizures and continuing improvements in cognition and behavior in patients treated with zorevunersen on
2mo agoSTOK BIIBStoke Therapeutics and Biogen Present Long-Term Clinical Data that Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)Business Wire–4-year data from the Phase 1/2a open-label extension (OLE) studies showed substantial and durable reductions in seizures and continuing improvements in cognition and behavior in patients treated with zorevunersen on
2mo agoBIIBLEQEMBI® (lecanemab) Subcutaneous Formulation as an Initiation Treatment for Early Alzheimer’s Disease Approved in ChinaGlobeNewswireTOKYO and CAMBRIDGE, Mass., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) announced today that the National Medical Products Administration (NMPA) of China has approved the
2mo agoSTOK BIIBStoke Therapeutics to Present at the Cantor Global Healthcare ConferenceBusiness WireStoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in
2mo agoSTOK BIIBStoke Therapeutics and Biogen Announce Presentations of Clinical Data from Studies of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)Business Wire–4-year data from the Phase 1/2a open-label extension (OLE) studies support the potential disease-modifying effects of zorevunersen– –Improvements in cognition and behavior sustained through 4 years, in addition to
2mo agoBIIB STOKStoke Therapeutics and Biogen Announce Presentations of Clinical Data from Studies of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)GlobeNewswire–4-year data from the Phase 1/2a open-label extension (OLE) studies support the potential disease-modifying effects of zorevunersen– –Improvements in cognition and behavior sustained through 4 years, in addition to
2mo agoBIIBCanada’s Drug Agency Issues Final Positive Recommendation Supporting Public Reimbursement of LEQEMBI® (lecanemab) for Early Alzheimer’s DiseaseGlobeNewswireTOKYO and CAMBRIDGE, Mass., Aug. 31, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB), announced today that Canada’s Drug Agency (CDA-AMC) has issued a final recommendation supporting public
2mo agoBIIBLEQEMBI IQLIK® (lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer’s DiseaseGlobeNewswireTOKYO and CAMBRIDGE, Mass., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB), announced today that once weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) is now
2mo agoBIIBLEQEMBI IQLIK®(lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer's DiseasePR NewswireEisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that once weekly lecanemab‑irmb subcutaneous injection (brand name: LEQEMBI IQLIK®)...
3mo agoBIIBBiogen Completes Acquisition of RayThera Inc.GlobeNewswireCAMBRIDGE, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced the completion of the acquisition of RayThera Inc., a privately held biotechnology company focused on discovering and
3mo agoSTOK BIIBStoke Therapeutics to Present at the Canaccord Genuity 46th Annual Growth ConferenceBusiness WireStoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in
3mo agoSTOK BIIBStoke Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business UpdatesBusiness Wire– Phase 3 EMPEROR study of zorevunersen in Dravet syndrome: Enrollment of 162 patients complete with data readout anticipated in Q3 2027 – – Pre-NDA meeting with FDA scheduled for H2 2026; rolling U.S. NDA submission
3mo agoSTOK BIIBStoke Therapeutics to Host Webcast and Conference Call to Discuss Second Quarter 2026 Business and Financial UpdatesBusiness WireStoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in
3mo agoBIIBSynapticure Launches Groundbreaking Ataxia Care Program, Expanding Access to Specialized Neurology NationwidePR NewswireSynapticure, a leading virtual care company dedicated to improving access and outcomes for patients and caregivers living with neurodegenerative...
3mo agoBIIBBiogen Appoints Michael J. Parini as Chief Legal OfficerGlobeNewswireCAMBRIDGE, Mass., July 15, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced the appointment of Michael J. Parini as Chief Legal Officer, effective August 3, 2026. Parini will serve as a member of
4mo agoBIIBLEQEMBI® Real-World LEADER Study Presented at AAIC® 2026 Finds Over 75% of Early Alzheimer’s Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of TreatmentGlobeNewswireTOKYO and CAMBRIDGE, Mass., July 14, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) announced today that results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study
4mo agoBIIBLEQEMBI® Real-World LEADER Study Presented at AAIC® 2026 Finds Over 75% of Early Alzheimer's Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of TreatmentPR NewswireEisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study ...
4mo agoBIIBBiogen Presents Phase 2 CELIA Data at AAIC Demonstrating Meaningful Clinical Outcomes and Robust Tau Reduction with Diranersen in Early Alzheimer’s DiseaseGlobeNewswireClinical outcomes: Diranersen demonstrated efficacy across all studied doses at 18 months, with consistent results across multiple prespecified clinical endpoints; the 60 mg dose showed the strongest response with
4mo agoBIIBFDA Approves LEQEMBI IQLIK® (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer’s DiseaseGlobeNewswireLEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance (approved in the U.S.) U.S. launch of LEQEMBI IQLIK as an initiation dose planned for late
4mo agoBIIBFDA Approves LEQEMBI IQLIK® (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer's DiseasePR NewswireEisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics...
4mo agoSTOK BIIBStoke Therapeutics Appoints Thomas McCauley, Ph.D., as Chief Scientific OfficerBusiness Wire–Dr. McCauley brings more than 25 years of experience building high-performing R&D organizations and translating early scientific discoveries into new medicines for people with severe diseases– Stoke
4mo agoBIIBLEQEMBI® Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer’s Disease Presented at the Alzheimer’s Association International Conference® (AAIC®) 2026GlobeNewswireTOKYO and CAMBRIDGE, Mass., July 12, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) announced today that new data presented at the Alzheimer’s Association International Conference® (AAIC®) 2026
4mo agoBIIBLEQEMBI® Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer's Disease Presented at the Alzheimer's Association International Conference® (AAIC®) 2026PR NewswireEisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that new data presented at the Alzheimer's Association International Conference®...
4mo agoSTOK BIIBStoke Therapeutics Announces Completion of Enrollment of 162 Patients Into the Phase 3 EMPEROR Study of Zorevunersen, an Investigational Medicine for the Treatment of Dravet SyndromeBusiness Wire—Company plans to initiate a rolling U.S. NDA submission to the FDA in the first quarter of 2027— —Phase 3 data readout anticipated in the third quarter of 2027 to complete the rolling U.S. NDA submission in the
4mo agoBIIBBiogen to Highlight Breadth of Alzheimer’s Disease Portfolio at AAIC 2026, Including Phase 2 CELIA Data for DiranersenGlobeNewswireDiranersen presentation will feature Phase 2 CELIA data in early Alzheimer’s disease, including clinical, biomarker and safety results for Biogen’s investigational tau-targeting ASO, following topline results announced
4mo agoNTHI LLY BIIB BBIOInternational Regulatory Pathways Have Supported Drug Development Across Biotech and PharmaGlobeNewswireDENVER, June 22, 2026 (GLOBE NEWSWIRE) -- (247marketnews.com) -- NeOnc Technologies Holdings (NASDAQ:NTHI) remains an early-stage biotechnology company, but the recent Abu Dhabi IND authorization for NEO212 highlights
4mo agoQNTM SNY RHHBY BIIB+1Novel Patented Myelin Drug-Discovery Strategy Targets Massive Unmet Need in Multiple SclerosisGlobeNewswireAUSTIN, Texas, June 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis ("MS") robs people of control over their own bodies — slowly, relentlessly and without a cure. More than 2.9
4mo agoBIIBBiogen Expands Immunology Pipeline with Agreement to Acquire RayThera Inc.GlobeNewswireCAMBRIDGE, Mass. and SAN DIEGO, June 17, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and RayThera Inc., a private biotechnology company focused on discovering and developing small molecule therapies in
5mo agoBIIBBiogen's Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular AtrophyGlobeNewswireDesignation is supported by an exploratory analysis from the Phase 1b study showing that some children with SMA previously treated with gene therapy who had suboptimal clinical status experienced slowing of
5mo agoBIIBEULAR 2026: Dapirolizumab Pegol Shows Potential to Reduce Flare Rates and Maintain Disease Control in Systemic Lupus ErythematosusGlobeNewswireSteroid use reduction and disease control: In additional results from the Phase 3 PHOENYCS GO study, dapirolizumab pegol (DZP) plus standard of care was associated with sustained disease control at lower glucocorticoid
5mo agoBIIBBiogen Announces Upcoming Kidney Presentations at European Renal Association and American Transplant CongressesGlobeNewswireData presentations across multiple kidney diseases illustrate the breadth of Biogen's nephrology portfolio with EMPAVELI® (pegcetacoplan) and felzartamab, an investigational anti-CD38 monoclonal antibody.
5mo agoBIIBUCB and Biogen Announce Publication in The Lancet of Positive Dapirolizumab Pegol (DZP) Phase 3 Study Results in Systemic Lupus ErythematosusGlobeNewswirePublication adds to previously reported findings from Phase 3 PHOENYCS GO study, demonstrating statistically significant improvement in disease activity at Week 48 with dapirolizumab pegol plus standard of care versus
5mo agoBIIB STOKStoke Therapeutics to Present at Upcoming Investor Conferences in JuneBusiness WireStoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine and has a lead investigational medicine, zorevunersen, in
5mo agoBIIB DNLIBiogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson's DiseaseGlobeNewswireThe Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122
6mo agoBIIB LLYBiogen advances Alzheimer's drug to late-stage trial despite disappointing dataCNBCBiogen said signals sugget the treatment decreases levels of tau and slows cognitive decline, particularly at the lowest dose.
6mo agoAPLS BIIBBiogen Completes Acquisition of Apellis PharmaceuticalsGlobeNewswireCAMBRIDGE, Mass., May 14, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced the successful completion of the acquisition of Apellis Pharmaceuticals, Inc. (NASDAQ:APLS). Apellis, a leader in advancing
6mo agoBIIBTopline Results from Phase 2 CELIA Study of Diranersen (BIIB080): First Study to Show Reduction in Tau Pathology and Cognitive Benefit in Patients with Early Alzheimer's DiseaseGlobeNewswireRobust reductions in tau pathology were observed across all studied doses, with results generally consistent with those observed in the Phase 1b study1Pre-specified analyses of cognitive endpoints demonstrated slowing of
6mo agoBIIBUpdate on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's DiseaseGlobeNewswireTOKYO and CAMBRIDGE, Mass., May 08, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months