Pegloticase

Amgen Reports Strong Global Demand in Q1 2025, Bolstering Long-Term Growth Outlook

20 days ago

• Amgen announced positive first quarter 2025 financial results, citing strong global demand across its product portfolio and successful new product launches. • Chairman and CEO Bob Bradway expressed confidence in Amgen's long-term growth prospects, supported by recent successful Phase 3 clinical trial results for several products. • The biotechnology company, which employs over 28,000 people globally, continues to focus on its mission of harnessing biology and technology to combat serious diseases.

Amgen's Uplizna Shows Sustained Efficacy in Myasthenia Gravis Patients Through One Year

2 months ago

• Amgen's Uplizna demonstrated durable efficacy in patients with acetylcholine receptor antibody-positive generalized myasthenia gravis, with 72.3% of treated patients showing significant improvement in daily living activities versus 45.2% on placebo at 52 weeks. • The anti-CD19 antibody therapy maintained its efficacy with an infrequent dosing schedule of just two doses per year following an initial loading dose, potentially offering a competitive advantage over current treatments requiring more frequent administration. • Regulatory filing for Uplizna in generalized myasthenia gravis is anticipated in the first half of 2025, with the FDA having already granted the therapy Orphan Drug Designation for this indication.

Amgen Charts Growth Strategy Amid Patent Cliff: Biosimilars and Therapeutic Innovation Take Center Stage

3 months ago

• Amgen reports strong 2024 performance with $33.4 billion revenue, but faces patent expiration challenges for blockbusters Otezla and Enbrel, driving strategic pivot towards biosimilars and portfolio diversification. • Company targets $4 billion in biosimilar sales by 2030, launching Wezlana and Pavblu, while advancing development in four key therapeutic areas: oncology, general medicine, inflammation, and rare disease. • Strategic initiatives include expansion of BiTE platform in oncology, development of obesity drug MariTide, and international market penetration for rare disease treatments following Horizon Therapeutics acquisition.

Protalix's PRX-115 Shows Promise in Phase I Gout Trial with Extended Dosing Potential

4 months ago

Protalix BioTherapeutics has completed a Phase I trial for PRX-115, demonstrating positive safety profile and prolonged urate-lowering effects in gout patients. The study results suggest potential advantages over current treatments, including reduced infusion frequency compared to existing therapies like Krystexxa.

Protalix's PRX-115 Demonstrates Promising Results in Phase I Gout Trial

6 months ago

• Protalix Biotherapeutics' PRX-115 shows dose-dependent reduction in plasma urate levels in Phase I trial for severe gout. • The Phase I trial demonstrated that PRX-115 was well-tolerated, with most adverse events being mild and resolving completely. • PRX-115 exhibited prolonged presence in plasma, up to 12 weeks, suggesting potential for less frequent dosing compared to existing treatments. • Protalix is planning a Phase II trial for PRX-115, with the trial design expected in the coming quarters and a launch anticipated in the second half of 2025.

Amgen Presents Positive Data for UPLIZNA in IgG4-Related Disease and KRYSTEXXA in Uncontrolled Gout at ACR 2024

6 months ago

• UPLIZNA demonstrated an 87% reduction in IgG4-RD flare risk compared to placebo in the Phase 3 MITIGATE study, with significant improvements in remission rates. • The MITIGATE study also showed that 89.7% of UPLIZNA-treated patients required no glucocorticoid treatment for disease control during the placebo-controlled period. • AGILE trial data support shortening KRYSTEXXA infusion time to 60 minutes when co-administered with methotrexate for uncontrolled gout, maintaining similar efficacy and safety. • 67.2% of participants receiving a 60-minute infusion of KRYSTEXXA with methotrexate achieved a urate level of <6mg/dL for ≥80% of the time during Month 6.

Amgen Presents Positive Data for UPLIZNA in IgG4-Related Disease and KRYSTEXXA Infusion Time Reduction

6 months ago

• UPLIZNA demonstrated an 87% reduction in IgG4-RD flare risk compared to placebo in the Phase 3 MITIGATE study, showcasing its potential as a novel treatment. • A significant 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, complete remission at Week 52 versus 22.4% on placebo. • AGILE trial data support the safety and efficacy of shortening KRYSTEXXA infusion time to 60 minutes when co-administered with methotrexate for uncontrolled gout. • 67.2% of patients receiving shorter KRYSTEXXA infusions with methotrexate achieved target urate levels, suggesting improved patient convenience.

Amgen's Q3 2024 Revenue Jumps 23% Fueled by Rare Disease Portfolio

7 months ago

• Amgen reported an impressive 23% revenue increase in Q3 2024, reaching $8.5 billion, driven by strong product sales, particularly in its rare disease portfolio. • The rare disease portfolio, boosted by the Horizon Therapeutics acquisition, saw a 21% year-over-year growth, with key drugs like Tepezza, Krystexxa, and Uplizna contributing significantly. • Despite success in rare diseases, Amgen discontinued the Phase II study of fipaxalparant for idiopathic pulmonary fibrosis after it failed to meet primary or secondary endpoints. • Amgen anticipates Phase II data for MariTide in overweight/obese adults with or without T2D in late 2024 and is planning a broad Phase III program in obesity and related conditions.

Drug Development Updates