Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics (HZNP) announced positive results from its Phase 2 clinical trial of dazodalibep for treating Sjögren’s syndrome, with the second patient population meeting the primary endpoint. The trial involved 109 patients with moderate-to-severe symptoms, achieving a 1.8-point reduction in ESSPRI scores compared to placebo, indicating significant symptom relief (p=0.0002). This follows positive results from another population in September 2022. Horizon plans to collaborate with the FDA to initiate a Phase 3 program in 2023, aiming to address unmet medical needs in this condition.

Horizon Therapeutics, as of January 11, 2023, reports a total of 228,768,464 ordinary shares with a nominal value of $0.0001 each, plus 40,000 deferred shares of €1.00. They hold 384,366 shares as treasury shares. The company has outstanding options for 4,803,451 ordinary shares and rights for an aggregate of 1,868,932 ordinary shares from restricted and performance stock units. Horizon is committed to developing therapies for rare and autoimmune diseases, with shares traded under the ticker HZNP on Nasdaq.

Horizon Therapeutics plc (NASDAQ: HZNP) has commenced a Phase 2 trial for daxdilimab, a human monoclonal antibody targeting anti-ILT7, to treat moderate-to-severe discoid lupus erythematosus (DLE). This skin condition lacks approved therapies and affects approximately 30,000 patients in the U.S. The trial aims to enroll about 100 participants to assess the drug's efficacy based on the CLASI-A score over 24 weeks. Daxdilimab shows promise by depleting plasmacytoid dendritic cells, a contributor to inflammation in DLE.

Horizon Therapeutics announces that the Brazilian Health Regulatory Agency (ANVISA) has approved UPLIZNA as a monotherapy for treating adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are AQP4-IgG+. This rare autoimmune condition affects approximately 10,000 individuals in Brazil, leading to severe outcomes like paralysis and vision loss. UPLIZNA has demonstrated significant efficacy in clinical trials, showing an 89% attack-free rate in AQP4-IgG+ patients over six months post-treatment. The drug's approval marks a crucial advancement in NMOSD treatment.

Horizon Therapeutics plc (NASDAQ: HZNP) has agreed to a recommended cash offer from Pillartree Limited, a subsidiary of Amgen Inc., valuing the company at approximately $27.8 billion. Each shareholder will receive $116.50 per share, a 47.9% premium over the recent closing price. The acquisition aims to leverage Amgen's expertise in inflammation and nephrology, enhancing Horizon's portfolio of innovative medicines. The deal is expected to be accretive to Amgen's earnings from 2024 and aims to yield significant cost efficiencies and cash flow benefits.

Horizon Therapeutics plc (Nasdaq: HZNP) announced the dosing of the first subject in a Phase 1 clinical trial for HZN-457, a small interfering RNA designed to treat gout by silencing liver xanthine dehydrogenase. This trial aims to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in up to 56 healthy volunteers. Gout affects over 9 million patients in the U.S., with many inadequately treated by current therapies. HZN-457 aims to lower uric acid levels effectively, potentially improving patient outcomes. The development is part of a collaboration with Arrowhead Pharmaceuticals (Nasdaq: ARWR).

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has received a $15 million milestone payment from Horizon Therapeutics (NASDAQ: HZNP) following the enrollment of the first subject in a Phase 1 clinical trial for HZN-457, aimed at treating gout. This candidate, previously known as ARO-XDH, targets liver xanthine dehydrogenase to lower uric acid levels. The study will enroll 56 healthy volunteers to assess safety, tolerability, and pharmacokinetics. The collaboration with Horizon is pivotal in advancing innovative treatments for the over 9 million gout patients in the U.S.