Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics plc (Nasdaq: HZNP) reported its Q1 2021 financial results, updating its full-year net sales and adjusted EBITDA guidance post-acquisition of Viela Bio, Inc. on March 15, 2021. Chairman Tim Walbert emphasized the acquisition enhances their biologics pipeline and research capabilities. Despite challenges from TEPEZZA supply disruptions due to COVID-19 vaccine orders, the company is optimistic about resuming supply and leveraging its expanded pipeline for growth. Financial highlights include significant year-over-year changes, reinforcing their growth trajectory.

HemoShear Therapeutics has identified a second drug target for gout in collaboration with Horizon Therapeutics (HZNP). This achievement, which follows the validation of a novel target, has resulted in two milestone payments to HemoShear. The collaboration utilizes the REVEAL-Tx™ platform aimed at developing therapies for gout, a condition affecting over nine million people in the U.S. HemoShear has the potential to earn over $500 million in milestone payments and royalties from successful developments by Horizon.

Horizon Therapeutics presented new data on UPLIZNA (inebilizumab-cdon) at the AAN 2021 meeting, showcasing long-term efficacy and safety from the N-MOmentum trial's open-label phase. UPLIZNA, the first FDA-approved monoclonal antibody for treating NMOSD, demonstrated a sustained reduction in attack risk, with 87.7% of initial UPLIZNA patients remaining attack-free over four years. Additionally, no new safety signals emerged, and treatment was generally well-tolerated. These findings enhance the treatment landscape for NMOSD patients, emphasizing UPLIZNA's long-term benefits.

Horizon Therapeutics plc (Nasdaq: HZNP) has published new pooled data from the TEPEZZA^® clinical trials in The Lancet Diabetes & Endocrinology. The findings indicate that TEPEZZA significantly improves symptoms of Thyroid Eye Disease (TED), including proptosis and diplopia, across various patient subgroups, with most maintaining long-term responses. The study involved 171 participants across two trials, showing high response rates for those treated with TEPEZZA compared to placebo. Safety assessments indicated no new safety concerns, with most adverse events being mild to moderate.

Horizon Therapeutics plc (Nasdaq: HZNP) will announce its Q1 2021 financial results on May 5, 2021. A live webcast is scheduled for 8 a.m. Eastern Time the same day, allowing management to discuss the financial and operational outcomes. Investors can access the webcast via the company’s website, with a replay available two hours post-event. Horizon focuses on developing medicines for rare and autoimmune diseases, applying scientific expertise to deliver impactful therapies.

Horizon Therapeutics plc (Nasdaq: HZNP) announced the results of the RECIPE trial published in Arthritis & Rheumatology, highlighting the efficacy of KRYSTEXXA (pegloticase) combined with mycophenolate mofetil in treating uncontrolled gout. The trial showed that 86% of patients on co-therapy achieved serum uric acid levels of ≤ 6 mg/dL at 12 weeks, compared to 40% on KRYSTEXXA alone. No infusion reactions occurred in the co-therapy group, while adverse events were more prevalent in the placebo group. The study underscores the potential benefit of immunomodulation in enhancing treatment outcomes.

Horizon Therapeutics announced that new data on UPLIZNA (inebilizumab-cdon) will be presented at the American Academy of Neurology’s 73rd Annual Meeting from April 17-22, 2021. UPLIZNA is the first FDA-approved B-cell depleter for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. Presentations include findings on pain reduction and long-term efficacy and safety outcomes from the N-MOmentum trial, alongside patient surveys. The event will also include therapeutic updates related to NMOSD treatment.

Horizon Therapeutics (Nasdaq: HZNP) announced FDA approval for a prior approval supplement (PAS) enabling increased TEPEZZA drug production, addressing supply disruptions that began in December 2020 due to COVID-19 vaccine manufacturing priorities. Patients affected by the disruption can resume treatment starting April. TEPEZZA, the only FDA-approved treatment for Thyroid Eye Disease, is expected to generate over $1.275 billion in net sales for 2021. Horizon anticipates initiating clinical trials in chronic TED and systemic sclerosis mid-2021 and further supply from a second manufacturer by year-end.