Biogen Inc. - BIIB STOCK NEWS

Talkiatry, a leading provider of in-network psychiatric care, has announced a new pathway for postpartum depression (PPD) support. This initiative aims to improve access to care for women experiencing postpartum mental health challenges through virtual appointments with board-certified psychiatrists. The company has launched new educational resources to help women identify PPD symptoms and schedule virtual consultations if needed.

Approximately one in eight new mothers in the United States report experiencing PPD symptoms. Despite its prevalence, access to timely care remains challenging due to a shortage of psychiatrists and long wait times. Talkiatry's telehealth alternative, developed in partnership with Biogen Inc. (Nasdaq: BIIB), aims to address these gaps in maternal mental healthcare.

The new PPD page on Talkiatry's website offers educational information, an online assessment tool, and a scheduling system for appointments with psychiatrists. Talkiatry provides virtual psychiatry and therapy covered by over 60 health insurance plans across 43 states, with new patients seen within days of making an appointment.

Biogen Inc. (Nasdaq: BIIB) has announced positive results from Parts B and C of the Phase 2/3 DEVOTE study, evaluating a higher dose regimen of nusinersen in spinal muscular atrophy (SMA). The study showed benefits in both previously treated and treatment-naïve individuals with infantile-onset or later-onset SMA.

Key findings include:

• The higher dose regimen (50/28 mg) led to significant improvements in motor function compared to a matched sham group
• More rapid reduction in neurofilament light chain (NfL), indicating faster slowing of neurodegeneration
• 67.8% reduction in the risk of death or permanent ventilation compared to sham
• Improvements in motor function for participants transitioning from the approved 12 mg regimen to the higher dose
• Safety profile similar to the approved 12 mg regimen

Biogen plans to submit regulatory applications globally for approval of the nusinersen higher dose regimen.

UCB and Biogen (NASDAQ: BIIB) announced positive topline results from the Phase 3 PHOENYCS GO study of dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, for moderate-to-severe systemic lupus erythematosus (SLE). The study met its primary endpoint, demonstrating greater improvement in disease activity compared to placebo after 48 weeks. Key secondary endpoints measuring disease activity and flares also showed clinical improvements.

Based on these results, UCB and Biogen are initiating a second Phase 3 trial, PHOENYCS FLY, in 2024. The companies aim to address the substantial unmet medical need for SLE patients, particularly women who are disproportionately affected. The safety profile of dapirolizumab pegol was generally consistent with previous studies and expectations for SLE patients receiving an immunomodulator.

Biogen Inc. (Nasdaq: BIIB) has announced the appointment of two new independent directors to its Board. Dr. Lloyd Minor, Dean of Stanford University School of Medicine, will join on October 1, 2024, and Prof Sir Menelas Pangalos, former Executive VP of Biopharmaceuticals R&D at AstraZeneca, will join on January 1, 2025.

These appointments bring significant scientific expertise and experience in medicine research and development to Biogen's Board. Dr. Minor has played a key role in Stanford Medicine's strategy and leadership, while Prof Sir Pangalos has a strong track record in biopharmaceutical R&D transformation.

The Board expects these new directors to contribute fresh perspectives and deep scientific knowledge to bolster Biogen's portfolio and drive long-term, sustainable growth.

Biogen Inc. (Nasdaq: BIIB) has announced positive topline results from the Phase 2/3 DEVOTE study evaluating a higher dose regimen of nusinersen for treating spinal muscular atrophy (SMA). The study met its primary endpoint, showing statistically significant improvement in motor function compared to a matched sham control group. The new regimen comprises a more rapid loading schedule and a higher maintenance dose than the approved SPINRAZA regimen.

Key findings include:

• Significant improvement in CHOP-INTEND scores at six months
• Faster reduction in neurofilament levels, indicating slower neurodegeneration
• Generally well-tolerated safety profile
• Positive trends across secondary endpoints and key biomarkers

Biogen plans to submit for regulatory approval of this investigational higher dose regimen, aiming to address the ongoing unmet needs in SMA treatment.

Leqembi® (lecanemab) has received Marketing Authorization from the MHRA in Great Britain for treating mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers. This makes Great Britain the first European country to authorize this treatment targeting an underlying cause of AD.

The approval is based on Phase 3 Clarity AD clinical trial data, which showed statistically significant results in primary and key secondary endpoints. Lecanemab selectively binds to and clears toxic Aβ protofibrils from the brain. Common side effects include infusion-related reactions and ARIA.

Eisai and Biogen will co-promote Leqembi in Great Britain, with Eisai as the Marketing Authorization holder. They are working with health authorities to make the medicine available to eligible patients as soon as possible.

Alcyone Therapeutics has received FDA approval to continue enrollment in the PIERRE pivotal IDE clinical study for the ThecaFlex DRx™ System. This implantable device is being investigated for routine subcutaneous administration of nusinersen to treat spinal muscular atrophy (SMA). The first stage, involving 10 SMA patients, has been completed with no device-related adverse events. The FDA has approved enrollment of an additional 80 SMA patients across 30 centers in the U.S. and Europe.

Key observations include:

• Implantation duration: 1-2 hours
• Hospital discharge: Within 24 hours
• Infusion procedure: Less than 30 minutes
• Actual nusinersen infusion: Less than 10 minutes

The ThecaFlex system aims to provide a less invasive, more accessible alternative to repeat lumbar puncture for SMA patients receiving SPINRAZA® (nusinersen) therapy.

Eisai and Biogen presented new clinical data for LEQEMBI® (lecanemab-irmb) at AAIC 2024, showing continued benefits for early Alzheimer's disease patients after three years of treatment. Key findings include:

- 51% of patients with no/low tau showed improved cognition and function over 3 years

- Lecanemab's dual action on protofibrils and plaques slows tau spread across all brain regions

- Three years of treatment reduced clinical decline by -0.95 on CDR-SB scale

- Safety profile remained consistent with no new concerns over 3 years

- Biomarker data suggests AD continues progressing after plaque clearance, supporting continued treatment

The results indicate lecanemab provides ongoing clinically meaningful benefits for early AD patients through its unique dual mechanism targeting toxic protofibrils and plaques.

Biogen (BIIB), Beckman Coulter, and Fujirebio have announced a collaboration to develop blood-based biomarkers and tests for tau pathology in Alzheimer's disease (AD). The partnership aims to create accessible, minimally invasive tools to stratify patients and monitor treatment response for future therapies targeting tau pathology in AD.

The collaboration will leverage Biogen's expertise in biomarker research and clinical study data, while Fujirebio and Beckman Coulter will handle diagnostic development, manufacturing, and commercialization. These tau-specific blood-based biomarkers could provide critical insights into AD's pathological processes and potentially accelerate the development of new therapies.