Biogen

The EMA’s CHMP now recommends Leqembi for Alzheimer’s patients with mild cognitive impairment or mild dementia, provided they carry one or no copies of the ApoE4 gene variant, due to lower ARIA risk. The EMA is expected to decide on Leqembi’s marketing authorisation in January 2025.

Eli Lilly’s ceperognastat, an O-GlcNAcase inhibitor, showed mixed results in a Phase 2 trial for Alzheimer’s, reducing brain atrophy and tau accumulation but causing faster cognitive decline and adverse events, suggesting potential off-target effects.

Eisai and partners win EU regulator's backing for Alzheimer's drug Leqembi, reversing a previous negative opinion. The drug should be limited to patients with one or no ApoE4 gene variant, linked to higher Alzheimer's risk. Leqembi has already been approved in Japan, China, and the US, with Europe potentially accounting for up to 30% of its worldwide peak sales.

EU drugs regulator recommends approval of Leqembi, an Alzheimer's drug by Eisai and Biogen, for patients with one or no ApoE4 gene variant. If accepted by the European Commission, it could become the first approved Alzheimer's treatment in the EU, with member states deciding on pricing and reimbursement.

The FDA has approved icobrain aria, the first AI software to detect, measure, and grade amyloid-related imaging abnormalities (ARIA) in Alzheimer's disease patients on anti-amyloid treatments. The software, trained on thousands of MRI scans, generates a quantitative report with severity scores, aiding radiologists in managing ARIA to enhance patient safety. Validation studies showed significant improvements in ARIA detection with the software's assistance, potentially bridging the gap between expert and non-expert readers.

IgA nephropathy affects 25-50 per million annually, with 20–40% progressing to end-stage kidney disease. Diagnosed cases in the US are expected to reach 135,000 by 2030. Treatments include ACE inhibitors, ARBs, corticosteroids, and immunosuppressants. FDA-approved treatments are TARPEYO, FILSPARI, and FABHALTA. The IgA nephropathy market is projected to reach ~USD 4.1 billion by 2034, driven by novel therapies like Novartis’ Atrasentan, Otsuka/Visterra’s Sibeprenlimab, Vertex/Alpine’s Povetacicept, and others.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

Third Rock Ventures leads $101M funding for Trace Neuroscience, aiming to treat ALS by replacing broken genetic machinery. Trace focuses on TDP-43, a molecule essential for RNA processing, which, when dysfunctional, impairs protein production linked to nerve-destroying disorders. The startup uses antisense therapy to correct UNC13A instructions, with a drug program targeting ALS and potentially other neurodegenerative diseases, set to enter human testing in 2026.

Eisai reports 3% Q2 FY2024 revenue growth to JPY 385 billion, driven by a 5% increase in the pharmaceutical segment, led by Lenvima, Dayvigo, and LEQEMBI. Despite a decline in operating profit due to increased SG&A expenses, the company maintains its full-year forecast and announces an interim dividend of JPY 80 per share. LEQEMBI's U.S. launch contributes JPY 16.3 billion in H1 sales, with 10,000 patients ready for treatment, though 6,000 face infusion delays. Eisai focuses on expanding infusion capacity and improving amyloid beta testing efficiency to enhance patient access and future profitability.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.