Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics (Nasdaq: HZNP) has made a significant five-year founding gift to the University of Notre Dame to establish the Patient Advocacy Initiative within the College of Science. This initiative aims to enhance training for students interested in advocating for patients with rare diseases. The funding will support curriculum development, experiential learning, and an annual patient advocacy summit. With over 7,000 known rare diseases affecting 400 million people globally, this program seeks to empower future leaders in patient advocacy.

Horizon Therapeutics (NASDAQ: HZNP) published data from the MIRROR clinical trial, demonstrating a significant efficacy increase of over 30 percentage points in response rates for patients receiving KRYSTEXXA (pegloticase) with methotrexate. In Month 6, 71% of patients achieved the primary efficacy endpoint compared to 39% with placebo. Infusion reactions dropped from 31% to 4%. The data is timely following the FDA's expanded labeling approval on July 7, 2022, which enhances treatment options for patients with uncontrolled gout. These findings aim to advance patient care significantly.

Horizon Therapeutics plc (NASDAQ: HZNP) collaborates with the International Agency for the Prevention of Blindness (IAPB) to promote World Sight Day. The initiative encourages five million people to pledge for vision screenings by October 13, 2022, under the theme #LoveYourEyes. Events will be held across the U.S. to offer free vision screenings and education, highlighting that over 7 million Americans suffer uncorrectable vision loss. The campaign aims to improve access to eye care and raise awareness about its importance.

Horizon Therapeutics announced positive results from its Phase 2 trial of dazodalibep for treating Sjögren’s syndrome, meeting the primary endpoint with a 6.3-point reduction in ESSDAI scores versus 4.1 points for placebo (p=0.017). The company plans to collaborate with the FDA to initiate a Phase 3 program in 2023. There were also numerical improvements in key secondary outcomes, and dazodalibep was well tolerated. Horizon's ongoing efforts target unmet needs in this autoimmune disease, impacting a significant patient population.

Horizon Therapeutics plc (Nasdaq: HZNP) announced a share repurchase program, authorizing the buyback of up to $500 million of its ordinary shares. This decision reflects the company's confidence in its strategy and commitment to enhancing shareholder value. As of June 30, 2022, Horizon had $1.89 billion in cash and cash equivalents, ensuring sufficient funding for the repurchase. The timing and amounts of shares repurchased will depend on market conditions and alternative investment opportunities.

Horizon Therapeutics has submitted a planning application to expand its manufacturing facility in Waterford, Ireland, adding approximately 320,000 square feet to its current 44,000-square-foot drug product facility. This expansion aims to create around 350 jobs over time and enhance Horizons' drug substance biologics capabilities. Horizon is collaborating with the Health Products Regulatory Authority and the U.S. Food and Drug Administration for licensure of sterile fill-finish manufacturing, with the first medicine expected to be approved from the existing facility in 2023.

Horizon Therapeutics plc (Nasdaq: HZNP) will participate in the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 2:05 p.m. ET in New York, NY. The event will be webcast live, accessible via Horizon's website, and a replay will be available for one year post-event. Horizon is dedicated to developing therapies for rare, autoimmune, and severe inflammatory diseases, aiming to transform patient lives through scientific innovation and compassion. For more information, visit their website.