Biogen

Eisai and Biogen announce completion of BLA submission to FDA for LEQEMBI autoinjector for Alzheimer's disease, based on Clarity AD data. LEQEMBI, indicated for early AD, aims to maintain effective drug concentrations and reduce hospital visits. Eisai leads global development and regulatory submissions, with co-commercialization by Eisai and Biogen.

Eisai completes rolling BLA submission to FDA for Leqembi subcutaneous autoinjector for weekly maintenance dosing in Alzheimer's disease patients.

Roche's trontinemab, an anti-Alzheimer's antibody, easily crosses the blood-brain barrier, clearing amyloid plaque faster and with fewer side effects. Phase 3 trials are planned for 2024, with results expected by 2028.

Morgan Stanley downgraded Biogen (NASDAQ:BIIB) from Overweight to Equal Weight, cutting the price target from $285 to $204 due to the underwhelming launch of Alzheimer's drug Leqembi. The firm reduced its 2033 revenue estimate for Leqembi from $5.6 billion to $2.4 billion, citing initial reimbursement and logistical issues, a negative CHMP opinion, and competition from Eli Lilly's Kisunla. Despite potential upside from ongoing trials and market expansion, Morgan Stanley sees limited upside for Biogen over the next 12 months.

AbbVie, a pharmaceutical firm with strong immunology and oncology portfolios, is compared against key competitors in the Biotechnology industry. Analysis reveals AbbVie's PE ratio is low, suggesting potential undervaluation, while its high PB ratio indicates overvaluation based on book value. A low PS ratio implies undervaluation based on sales. AbbVie's high ROE, EBITDA, and gross profit highlight strong profitability and operational efficiency, but low revenue growth indicates challenges in market expansion.

Eisai and Biogen presented lecanemab-irmb findings at CTAD, showing benefits of continued treatment for early Alzheimer's disease, including reduced disease progression and improved cognitive function. No new safety issues were reported, and a new method to quantify protofibrils in cerebrospinal fluid was developed, suggesting protofibrils' role in neurodegeneration. Long-term U.S. clinical studies indicated patient satisfaction with lecanemab, and the AHEAD 3-45 study, focusing on preclinical AD, completed enrollment in October 2024. Professor Lars Lannfelt received the CTAD Lifetime Achievement Award for his contributions to AD research.

Big Pharma companies like Pfizer, Johnson & Johnson, Biogen, and Novartis are focusing on new products to drive future growth amid patent cliffs and market challenges. Pfizer's Prevnar 20 holds strong market share despite competition, while J&J's Tremfya gains traction as Stelara faces biosimilar competition. Biogen's Leqembi struggles with uptake due to infrastructure challenges, and Novartis relies on new oncology drugs to offset patent expirations and price negotiations.

FDA's regulatory changes benefit cell and gene therapy companies; Tharimmune's TH-104 receives positive EMA feedback; Lexeo's LX-1001 shows interim positive results in Alzheimer's; Biogen and Neomorph partner for $1.45B in molecular glue degraders; Synox extends series B by $17M for emactuzumab; Shionogi's ensitrelvir reduces COVID-19 risk post-exposure.

Eisai and Biogen present lecanemab findings at CTAD, showing benefits of continued treatment in early Alzheimer's disease, including reduced disease progression and improved patient satisfaction. A new testing method highlights the link between protofibrils and neurodegenerative biomarkers, suggesting protofibrils' role in AD neurodegeneration. The AHEAD study uses blood biomarkers to predict brain amyloid accumulation in preclinical AD, improving screening eligibility.