Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics (Nasdaq: HZNP) announced the presentation of multiple analyses of UPLIZNA, its anti-CD19 B-cell-depleting monoclonal antibody, at the 2023 American Academy of Neurology Annual Meeting in Boston, from April 22-27. UPLIZNA is FDA-approved for treating neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4-immunoglobulin G positive. Key presentations will include an oral session on the relationship between B-cell subsets and NMOSD attacks slated for April 23 at 1:48 p.m. EDT, and key safety and efficacy studies presented in poster sessions on April 27. The data aims to enhance understanding of NMOSD mechanisms and improve patient outcomes.

Horizon Therapeutics today launched the third annual global innovation challenge, The Horizon Prize, in partnership with MIT Solve. This initiative invites global entrepreneurs to propose solutions to enhance the rare disease community. A winner will receive $150,000 in funding. The challenge focuses on reducing environmental impacts in rare disease healthcare, tackling inefficiencies in diagnostics, clinical trials, and waste management. The submission deadline is June 23, 2023. Previous winners, like EB Research Partnership, have leveraged the prize to enhance patient connectivity. Tim Walbert, CEO of Horizon, emphasizes the importance of innovative solutions to improve quality of life for rare disease patients.

Horizon Therapeutics plc has announced that the Irish High Court will hear the proposed acquisition by Pillartree Limited, a subsidiary of Amgen, on May 22, 2023. This acquisition involves the complete buyout of Horizon's ordinary share capital under the Irish Companies Act. Shareholders must inform Horizon's solicitors by May 15, 2023 if they wish to attend the Court Hearing, indicating their stance on the application. The completion of the transaction is also pending review by the United States Federal Trade Commission and is expected to finalize in the first half of 2023, contingent upon regulatory approvals. Horizon will notify the Court if the hearing needs to be postponed due to unmet conditions.

Horizon Therapeutics plc has received FDA approval for an updated indication for TEPEZZA, the first and only treatment for Thyroid Eye Disease (TED). This update allows for treatment regardless of TED activity or duration, broadening access for patients. Positive results from a Phase 4 clinical trial indicated statistically significant reduction in proptosis among patients with a diagnosis of TED between 2 to 10 years. The trial showed no new safety concerns. The update aims to facilitate quicker access to therapy for eligible patients.

TEPEZZA is crucial as TED can lead to severe complications, including vision loss. Horizon plans to present the trial data at future medical congresses and seeks publication in a peer-reviewed journal.

Horizon Therapeutics plc (NASDAQ: HZNP) will release its first-quarter 2023 financial results on May 3, 2023, before the U.S. markets open. Due to the ongoing acquisition by Amgen, no conference call will be held to discuss these results. The earnings press release will be available on the company's Investor Relations page.

Horizon focuses on developing medicines for rare, autoimmune, and severe inflammatory diseases. The company emphasizes the importance of science and compassion in transforming patient lives. For further details on their mission and pipeline, visit their website.

Horizon Therapeutics (NASDAQ: HZNP) announced positive results from a Phase 4 clinical trial for TEPEZZA, aimed at treating adults with chronic Thyroid Eye Disease (TED) and low disease activity. The trial demonstrated a statistically significant reduction in proptosis: a mean decrease of 2.41 mm for TEPEZZA patients versus 0.92 mm for placebo (p=0.0004) at Week 24. Additionally, 62% of TEPEZZA patients achieved a clinically meaningful improvement in proptosis (≥2 mm) compared to 25% for placebo (p=0.0134). The results support TEPEZZA's efficacy across a diverse patient population, regardless of disease duration (mean of 5.2 years). There were no new safety signals observed, reinforcing TEPEZZA’s well-established safety profile. Horizon plans to discuss these findings with the FDA for potential regulatory steps.