BRUSSELS, Belgium and CAMBRIDGE, Mass., Nov. 19, 2024 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC.

TOKYO and CAMBRIDGE, Mass., Nov. 14, 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 a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.2  

-New testing method highlights link between protofibrils and biomarkers for neurodegeneration--Patient and caregiver perspectives on five-year treatment with lecanemab -- Utilization of blood biomarkers to predict brain amyloid accumulation in AHEAD study of preclinical AD-

NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Biogen Inc. (NASDAQ: BIIB) on behalf of long-term stockholders following a class action complaint that was filed against Biogen on May 22, 2024 with a Class Period from February 3, 2022 to February 13, 2024. Our investigation concerns whether the board of directors of Biogen have breached their fiduciary duties to the company. 

CAMBRIDGE, Mass. and SAN DIEGO, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Neomorph Inc. announced a research collaboration to discover and develop molecular glue degraders for priority targets in Alzheimer’s, rare neurological, and immunological diseases.

CAMBRIDGE, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has appointed Daniel Quirk, M.D., M.P.H., M.B.A. as Chief Medical Officer and Head of Medical Affairs, effective October 28, 2024. Dr. Quirk will report to Priya Singhal, M.D., M.P.H., Head of Development at Biogen.

Robin Kramer, Chief Accounting Officer, to Succeed Him

CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – today presented complete results from the Phase 2 IGNAZ study evaluating felzartamab, an investigational anti-CD38 monoclonal antibody, in people living with IgA nephropathy (IgAN). The results showed substantial reductions in proteinuria, stabilization of kidney function, and sustained treatment effect more than 18 months after the last dose of felzartamab. The complete results were shared during an oral presentation at Kidney Week 2024, the American Society of Nephrology’s annual meeting, in San Diego, California.

CAMBRIDGE, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced upcoming data presentations and programming at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference, taking place October 29 - November 1, in Madrid, Spain. The presentations will include updates on new scientific findings from Biogen’s Alzheimer’s portfolio, highlighting data on different aspects of treatment and data examining preclinical Alzheimer’s disease and race.

CAMBRIDGE, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the company will present a variety of new data from its felzartamab clinical development program at Kidney Week 2024, the American Society of Nephrology’s (ASN) annual meeting, taking place October 23-27 in San Diego, California. Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated diseases.

Micron, Biogen, and Regeneron are three stocks that appear oversold and could present substantial buying opportunities for investors seeking recovery plays.

CAMBRIDGE, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – Biogen announced today that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. The FDA grants BTD to drug candidates for serious or life-threatening conditions and that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides additional opportunities to engage the FDA and to support the drug development program through Fast Track designation features.

CAMBRIDGE, Mass., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced detailed results from Part B and Part C of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of an investigational higher dose regimen of nusinersen in spinal muscular atrophy (SMA), showing benefits in both individuals previously treated and treatment-naïve to nusinersen with infantile-onset or later-onset SMA. The investigational, higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen (SPINRAZA®). Data to be presented during the World Muscle Society (WMS) 2024 Congress (Oct. 8-12, 2024 in Prague) highlight the potential of this investigational higher dose regimen to help address remaining unmet need in SMA.

BRUSSELS and CAMBRIDGE, Mass., Sept. 24, 2024 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe systemic lupus erythematosus (SLE). Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks versus placebo in addition to SOC. Clinical improvements were observed among key secondary endpoints measuring disease activity and flares.

Dr. Lloyd Minor and Prof Sir Menelas Pangalos bring significant scientific expertise and considerable experience in medicine research and development

CAMBRIDGE, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced positive, topline data from the pivotal cohort (Part B) of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of a higher dose regimen of nusinersen in treatment-naïve, symptomatic infants with spinal muscular atrophy (SMA). The investigational higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and a higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen (SPINRAZA). The study met its primary endpoint at six months, achieving a statistically significant improvement in motor function in infants who received the higher dose regimen as compared to a prespecified matched sham (untreated) control group from the ENDEAR study.

In a groundbreaking study, Chinese scientists have revealed that classical music could be a powerful tool in the fight against treatment-resistant depression, a condition that affects nearly 50% of patients with major depressive disorder (MDD). Published in Cell Reports, the research demonstrates that music can synchronize neural circuits in the brain, leading to significant antidepressant … Continue reading "New Study Reveals How Classical Music Could Revolutionize Depression Care"

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51% of No Tau / Low Tau Patients Showed Improved Cognition and Function Over Three Years; Only Lecanemab Has Clinical Data in No Tau / Low Tau Patient Group

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 and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and potentially commercialize new tests for tau pathology in Alzheimer’s disease (AD). The development of tau-specific blood-based biomarkers that can measure a patient’s tau burden could provide critical insights into the underlying pathological processes of AD and may help advance the development of a new generation of therapies impacting tau pathology.

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) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).1

NEW YORK, July 25, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Biogen Inc. (NASDAQ: BIIB) on behalf of long-term stockholders following a class action complaint that was filed against Biogen on May 22, 2024 with a Class Period from February 3, 2022 to February 13, 2024. Our investigation concerns whether the board of directors of Biogen have breached their fiduciary duties to the company.

Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ: BIIB) announced topline results from the Phase 2 KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET). The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint, The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) total score, in participants with ET. In addition, there were no statistically significant differences demonstrated for any dose of SAGE-324 versus placebo in the change from baseline to Day 91 on the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily Living (ADL) Composite Score. Given these results, Sage and Biogen will close the ongoing open label safety study of SAGE-324 in ET and do not plan to conduct further clinical development of SAGE-324 in ET. The companies are evaluating next steps, if any, for other potential indications.

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.

The Law Offices of Frank R. Cruz reminds investors of the upcoming July 22, 2024 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB) securities between February 3, 2022 and February 13, 2024, inclusive (the “Class Period”).