Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics announced second-quarter 2022 results, reporting net sales of $876.4 million, a 5% increase year-over-year. The orphan segment grew 13% to $841.3 million. However, net income fell to $61.0 million from $158.1 million, a 61% decline. The company revised its full-year 2022 guidance for net sales down to $3.53-$3.60 billion due to anticipated high-teens growth for TEPEZZA, down from mid-30s. Positive FDA approval was granted for KRYSTEXXA's expanded label, potentially increasing patient access.

Horizon Therapeutics has been recognized by Seramount as one of the Best Companies for Multicultural Women, highlighting efforts in equitable hiring and promotion practices. CEO Tim Walbert emphasized the company's commitment to diversity and allyship. Additionally, Horizon has ranked No. 16 on Fortune's 2022 Best Workplaces for Millennials list for the third consecutive year. These achievements reflect Horizon's ongoing commitment to fostering an inclusive work environment that supports all employees, particularly women and multicultural individuals.

Horizon Therapeutics plc (NASDAQ: HZNP) has announced the selection of 30 global patient advocacy organizations to receive the inaugural #RAREis Global Advocate Grant. Each organization will receive a one-time grant of $5,000 to support rare disease communities. Over 120 applications were submitted from 12 countries, addressing nearly 100 rare diseases. The grant aims to enhance education, accessibility, and support for patients and caregivers facing rare diseases, impacting over 400 million people worldwide.

Horizon Therapeutics (NASDAQ: HZNP) is launching an awareness campaign for Graves' Disease Awareness Month in July. The initiative features advocates Wanda Durant and Gail Devers, aiming to educate those with Graves' disease about the risk of Thyroid Eye Disease (TED), a related autoimmune condition that can lead to vision loss. Approximately 50% of Graves' patients may develop TED, which requires specialized treatment. The campaign includes podcasts, educational videos, and social media outreach to empower patients to recognize symptoms and seek timely care.

Horizon Therapeutics has announced the FDA’s approval of a supplemental Biologics License Application (sBLA) to expand the labeling of KRYSTEXXA (pegloticase) to include its co-administration with methotrexate for treating patients with uncontrolled gout. This approval is based on the MIRROR randomized controlled trial, which demonstrated a more than 30% increase in efficacy and a reduction in infusion reactions from 31% to 4%. The incorporation of methotrexate is expected to enhance treatment response and compliance, addressing a significant patient need.

Horizon Therapeutics plc (Nasdaq: HZNP) will release its Q2 2022 financial results on August 3, 2022, at 8 a.m. Eastern Time. A live webcast will follow, allowing management to present an overview of the company's financial and operational performance. Investors are encouraged to join the webcast via Horizon's investor relations website, with a replay available two hours post-event. Horizon is focused on developing and commercializing medicines for rare and autoimmune diseases, highlighting their commitment to impactful therapies.

Horizon Therapeutics presents new findings from the N-MOmentum Phase 3 trial of UPLIZNA at the European Academy of Neurology Congress, demonstrating its efficacy in reducing NMOSD attacks. UPLIZNA is the first targeted therapy for anti-AQP4-IgG+ adults with NMOSD, receiving EC approval on April 25, 2022. Results show that EU participants treated with UPLIZNA had 12.5% attack rates compared to 30% in placebo, while non-EU rates were 10.7% vs 45.2%. Hospitalizations were also lower in UPLIZNA recipients, indicating its potential as a vital treatment option for this severe autoimmune disease.

Horizon Therapeutics plc (Nasdaq: HZNP) has submitted a regulatory filing for UPLIZNA to the Brazil National Health Surveillance Agency (ANVISA) for treating adult patients with anti-AQP4-IgG+ neuromyelitis optica spectrum disorder (NMOSD). This filing signifies a commitment to expand treatment options for NMOSD, affecting around 10,000 patients in Brazil. UPLIZNA previously demonstrated significant efficacy in reducing NMOSD attacks during the N-MOmentum Phase 3 trial, showing an 89% attack-free rate within six months post-treatment. The therapy has already received approvals in the U.S., Japan, and Europe.