Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics announced that the FDA granted priority review for a supplemental Biologics License Application (sBLA) to expand KRYSTEXXA label to include its use with methotrexate for chronic gout treatment.

This decision is based on the MIRROR trial, revealing that 71% of patients receiving the combination achieved a complete response in uric acid levels.

The Prescription Drug User Fee Act (PDUFA) date is set for July 7, 2022.

Horizon Therapeutics reported a robust financial performance for Q4 2021, with net sales reaching $1.01 billion, a 36% increase year-over-year. The company recorded GAAP net income of $173.2 million and an adjusted EBITDA of $416 million. For the full year, net sales totaled $3.23 billion, up 47%, driven by strong demand for TEPEZZA and KRYSTEXXA, with respective net sales growth of 103% and 39%. Looking ahead, Horizon anticipates 2022 net sales between $3.9 billion and $4.0 billion, reflecting 22% growth at the midpoint.

Horizon Therapeutics plc has launched the #RAREis Representation program, aiming to enhance equity in the rare disease community. The program features a new website section for community feedback on issues affecting rare disease equity, which will inform future initiatives. A webcast conversation on these topics will occur on February 28. As part of its ongoing commitment, Horizon will also engage through global Rare Disease Day efforts to raise awareness. The initiative addresses the challenges faced by approximately 400 million individuals affected by rare diseases worldwide.

Horizon Therapeutics plc (HZNP) has initiated the first patient enrollment in its Phase 3 clinical trial, OPTIC-J, in Japan to evaluate teprotumumab (TEPEZZA) for treating active Thyroid Eye Disease (TED). This trial, based on prior successful studies, aims to assess the drug's efficacy, safety, and tolerability in approximately 50 participants over 24 weeks. TEPEZZA, the first FDA-approved therapy for TED in the U.S., addresses critical symptoms like proptosis and diplopia. The initiative responds to the significant medical need in Japan, where effective treatment options are limited.

Horizon Therapeutics plc (Nasdaq: HZNP) will present at the Cowen and Company 42nd Annual Health Care Conference on March 8, 2022, at 11:10 a.m. ET. The presentation will be available via a live webcast on Horizon's website, with a replay accessible afterward. Horizon focuses on developing therapies for rare, autoimmune, and severe inflammatory diseases. For more information, visit www.horizontherapeutics.com.

Horizon Therapeutics has appointed Sean Clayton as executive vice president and general counsel, effective February 28. Clayton, currently a partner at Cooley LLP, has over a decade of experience with Horizon, advising on corporate and transactional matters, including the company's IPO in 2011. His extensive knowledge of the biotechnology sector and Horizon's strategy is expected to support the company's growth. Horizon aims to develop impactful therapies for rare and autoimmune diseases, aligning with its mission to combine science and compassion.

Horizon Therapeutics (HZNP) announced new analysis results showing that treatment with UPLIZNA effectively reduces the severity of acute attacks in patients with neuromyelitis optica spectrum disorder (NMOSD). During the N-MOmentum Phase 2/3 trial, 89% of patients treated with UPLIZNA remained attack-free, compared to 58% in the placebo group. The analysis also highlighted a correlation between attack severity and disease biomarkers, providing insight into UPLIZNA's clinical impact. These findings were presented at the NANOS 2022 meeting in Austin, Texas.