NASDAQ:HZNP

Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Daxdilimab for the Treatment of Systemic Lupus Erythematosus (SLE) Did Not Meet Primary Endpoint

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星期五, 七月 21, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, OGC, Baseline, Patient, SLE, Medical imaging

BICLA is a composite measure indicating low SLE disease activity.

Key Points: 
  • BICLA is a composite measure indicating low SLE disease activity.
  • “While we are disappointed that the trial did not meet its primary endpoint, we will continue to work with investigators to assess these data to determine next steps for our SLE clinical program,” said Elizabeth H.Z.
  • Thompson, Ph.D., executive vice president, research and development, Horizon.
  • “I would like to thank the patients and investigators for their participation in the trial.”

Horizon Therapeutics plc to Release Second-Quarter 2023 Financial Results on Aug. 8, 2023

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星期一, 七月 17, 2023
Biotechnology, Health, Science, Pharmaceutical, Research, Amgen, Acquisition, Pharmaceutical industry, Cryptocurrency

Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it will release its second-quarter 2023 financial results on Tuesday, Aug. 8, 2023, prior to the open of the U.S. financial markets.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it will release its second-quarter 2023 financial results on Tuesday, Aug. 8, 2023, prior to the open of the U.S. financial markets.
  • With the pending acquisition by Amgen Inc. and applicable securities laws, Horizon will not be hosting a conference call to discuss its financial results.
  • The earnings press release will be publicly available on the Investor Relations page of its website at https://ir.horizontherapeutics.com .

Long-Term Data From the MIRROR Randomized Controlled Trial of KRYSTEXXA® (pegloticase) Injection With Methotrexate Published in ACR Open Rheumatology

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星期四, 七月 6, 2023
Biotechnology, FDA, Health, General Health, Pharmaceutical, Other Science, Medical Devices, Research, Hospitals, Science, Clinical Trials, Birmingham, Birmingham School of Law, Methotrexate, Randomized controlled trial, University, Rheumatology, Patient, Month, MIRROR, American College of Rheumatology, Pharmaceutical industry

Horizon Therapeutics plc (Nasdaq: HZNP) today announced the publication of the long-term data from the MIRROR randomized controlled clinical trial of KRYSTEXXA® (pegloticase) injection with methotrexate, a commonly used immunomodulator, in ACR Open Rheumatology [ https://doi.org/10.1002/acr2.11578 ].

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced the publication of the long-term data from the MIRROR randomized controlled clinical trial of KRYSTEXXA® (pegloticase) injection with methotrexate, a commonly used immunomodulator, in ACR Open Rheumatology [ https://doi.org/10.1002/acr2.11578 ].
  • “Encouragingly, urate-lowering efficacy with the co-therapy approach was sustained over time with continued treatment in most patients.
  • The improvement in both groups was clinically meaningful (meaningful clinically important difference [MCID]: −0.22) but was not significantly different between groups (difference: −0.04 [−0.21, 0.13], p=0.6287).
  • Patients with questions can speak to a Gout Nurse Advocate at 833-469-4688.

New Analysis of MRI Findings Shows UPLIZNA® (inebilizumab-cdon) Reduced the Formation of Subclinical Spinal Cord Lesions in People With Neuromyelitis Optica Spectrum Disorder (NMOSD)

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星期五, 六月 30, 2023
Research, Radiology, Pharmaceutical, Optical, Medical Devices, Clinical Trials, Science, Biotechnology, Neurology, FDA, Other Science, Health, EAN, OLP, Civil service commission, ANVISA, Spinal cord, RCP, European Academy of Neurology, Prognosis, NMOSD, MRI, Congress, European Academy of Allergy and Clinical Immunology, European Commission, Patient, Physician, Optic nerve, Brazilian Health Regulatory Agency, Horizon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Pharmaceutical industry, Medical imaging

This analysis is being presented at the 9th Congress of the European Academy of Neurology (EAN), July 1-4 in Budapest.

Key Points: 
  • This analysis is being presented at the 9th Congress of the European Academy of Neurology (EAN), July 1-4 in Budapest.
  • Results from this post-hoc analysis demonstrate that UPLIZNA effectively reduced the formation of subclinical MRI lesions, while also showing an association between subclinical spinal cord lesions and future attacks.
  • Subsequent MRI findings showed that the formation of these lesions decreased as treatment with UPLIZNA continued.
  • Interestingly, these findings showed that subclinical lesions were associated with domain-specific attacks in the following year.

TEPEZZA® (teprotumumab) Approved in Brazil for the Treatment of Active Thyroid Eye Disease (TED)

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星期一, 六月 26, 2023
Science, Biotechnology, Research, Pharmaceutical, Optical, Health, FDA, Clinical Trials, Exophthalmos, ANVISA, OPTIC, Diplopia, Medicine, Patient, Autoimmune disease, CAS, Brazilian Health Regulatory Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, TED

Horizon Therapeutics plc (Nasdaq: HZNP) today announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED.
  • TEPEZZA is the first and only medicine approved for active TED in Brazil, filling a significant unmet need for those who are living with this progressive autoimmune disease that can threaten vision.
  • The first trial in Japan (OPTIC-J) is evaluating TEPEZZA for the treatment of TED patients with disease duration of nine months or less and high clinical activity score (CAS), which is a measure of disease activity.
  • The second is evaluating TEPEZZA for the treatment of adults with disease duration of two to ten years and low CAS.

Horizon Therapeutics plc Announces Positive Topline Data from Phase 3 Clinical Trial (OPTIC-J) in Japan Evaluating TEPEZZA® (teprotumumab-trbw) for the Treatment of Active Thyroid Eye Disease (TED)

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星期四, 六月 22, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Biotechnology, Exophthalmos, Steroid, CAS, Cover My Eyes (Pain and Heaven), Diplopia, Patient, Red, Week, Graves' ophthalmopathy, Disease, TED, Pharmaceutical industry

Horizon Therapeutics plc (Nasdaq: HZNP) today announced positive topline results from its randomized, double-masked, placebo-controlled Phase 3 clinical trial evaluating TEPEZZA for the treatment of TED in Japanese patients with higher levels of disease activity, as measured by clinical activity score (CAS).

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced positive topline results from its randomized, double-masked, placebo-controlled Phase 3 clinical trial evaluating TEPEZZA for the treatment of TED in Japanese patients with higher levels of disease activity, as measured by clinical activity score (CAS).
  • At Week 24, 89% of patients treated with TEPEZZA had a clinically meaningful improvement in proptosis (≥2 mm) compared with placebo (11%) (p
  • Additional data from the trial will be presented at a medical congress and published in a peer-reviewed medical journal.
  • The trial methodology is based on the OPTIC Phase 3 trial conducted in the United States and Europe.

New Data from TEPEZZA® (teprotumumab-trbw) Clinical Trials and Real-World Analyses Shed Light on Link Between Thyroid Autoimmunity and Hearing Risks

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星期六, 六月 17, 2023
Pharmaceutical, Optical, Health, Clinical Trials, ENDO, Endocrine Practice, P81, University, Prevalence, AE, Emeritus, TJ Smith Stakes, Graves' ophthalmopathy, Week, Tinnitus, FACP, Aes, AACE, Huber loss, Human, Medicine, Research, Science, Visual Science, Incidence, Teprotumumab, Data, Patient, Risk, Michigan Medicine, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, TED, Pharmaceutical industry, Ophthalmology

Decreased hearing, particularly at high frequencies, has been observed in people with Graves’ disease, but specific prevalence data among the population with TED is limited.

Key Points: 
  • Decreased hearing, particularly at high frequencies, has been observed in people with Graves’ disease, but specific prevalence data among the population with TED is limited.
  • An analysis presented at ENDO ( P81, TJ Smith ) assessed data on hearing-related medical claims among people with Graves’ disease, TED and those who received TEPEZZA treatment.
  • In clinical trials, hearing-related AEs with insulin-like growth factor-I receptor inhibitors have been reported.
  • We will continue to advance the science of Thyroid Eye Disease with the patient voice at the forefront of all we do.”

Additional Data from Phase 4 TEPEZZA® (teprotumumab-trbw) Clinical Trial Presented at the Endocrine Society Annual Meeting Reinforces Efficacy in People with Thyroid Eye Disease (TED) Regardless of Disease Activity or Duration

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星期六, 六月 17, 2023
Pharmaceutical, Optical, Health, Clinical Trials, ENDO, Exophthalmos, Orbital, Graves' ophthalmopathy, Week, OD, Diplopia, Medicine, Research, MS, Patient, CAS, Diagnosis, Cedars-Sinai Medical Center, The Rheumatoid Arthritis Quality of Life Questionnaire, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SD, Food, Safety, Disease, TED, Pharmaceutical industry

The oral presentation at the Endocrine Society Annual Meeting (ENDO 2023) supports the efficacy and safety of TEPEZZA in TED patients regardless of disease activity or duration.

Key Points: 
  • The oral presentation at the Endocrine Society Annual Meeting (ENDO 2023) supports the efficacy and safety of TEPEZZA in TED patients regardless of disease activity or duration.
  • “Thyroid Eye Disease is a heterogenous disease, and its impact is not always immediately visible, affecting patients both physically in day-to-day activities, and mentally due to the emotional distress that accompanies the disease.
  • The mean duration of disease for TEPEZZA and placebo patients was 5.1 years (SD 1.88) and 5.4 years (SD 1.61), respectively.
  • The mean CAS for TEPEZZA and placebo patients was 0.3 (SD 0.47) and 0.5 (SD 0.51), respectively.

Horizon Therapeutics plc (“Horizon”) Rule 2.12 Announcement

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星期二, 六月 13, 2023
Pharmaceutical, Professional Services, Health, Finance, International Securities Identification Number, Treasury, Holding company, Security (finance)

In accordance with Rule 2.12 of the Irish Takeover Panel Act, 1997, Takeover Rules, 2022 (the “Irish Takeover Rules”), Horizon confirms that, as of the close of business on June 9, 2023, Horizon’s issued ordinary share capital is comprised of 228,928,661 ordinary shares, nominal value $0.0001 per share (the “Ordinary Shares”) and 40,000 deferred ordinary shares of €1.00 each.

Key Points: 
  • In accordance with Rule 2.12 of the Irish Takeover Panel Act, 1997, Takeover Rules, 2022 (the “Irish Takeover Rules”), Horizon confirms that, as of the close of business on June 9, 2023, Horizon’s issued ordinary share capital is comprised of 228,928,661 ordinary shares, nominal value $0.0001 per share (the “Ordinary Shares”) and 40,000 deferred ordinary shares of €1.00 each.
  • The Company has 384,366 Ordinary Shares which are held as treasury shares.
  • The Ordinary Shares are admitted to trading on the Nasdaq Global Select Market under the ticker symbol “HZNP”.
  • The International Securities Identification Number for these securities is IE00BQPVQZ61.

UPLIZNA® (inebilizumab-cdon) Pivotal Trial Publication Integrating MRI and Biomarker Evaluation Shows Accuracy and Uniformity of Attack Diagnoses for Neuromyelitis Optica Spectrum Disorder (NMOSD)

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星期一, 六月 12, 2023
Other Health, Research, General Health, Pharmaceutical, Optical, Genetics, Clinical Trials, Science, Biotechnology, Neurology, FDA, Health, Optic neuritis, Multiple Sclerosis Journal, Myelitis, Central nervous system, Attack, University, Glial fibrillary acidic protein, Serum, AC, Multiple sclerosis, University of Virginia School of Medicine, MRI, Virginia School for Girls, Risk, Neuromyelitis optica spectrum disorder, Neuro, Horizon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Pharmaceutical industry, Medical device, Medical imaging, NMOSD

Properly defining NMOSD attacks is essential to inform treatment decisions, yet there are no universally accepted criteria for accurate and objective diagnosis of NMOSD attacks.

Key Points: 
  • Properly defining NMOSD attacks is essential to inform treatment decisions, yet there are no universally accepted criteria for accurate and objective diagnosis of NMOSD attacks.
  • The N-MOmentum pivotal trial, which demonstrated UPLIZNA reduced the risk of attacks associated with the disease, introduced a new approach for attack analysis.
  • Attacks were evaluated by an adjudication committee (AC, comprised of two neurologists and one neuro-ophthalmologist).
  • MRI and sGFAP biomarker findings provided additional specificity in the attack adjudication process.