Horizon Therapeutics HZNP announced positive top-line results from its phase IV study of Tepezza for the treatment of Thyroid Eye Disease (TED) in adult patients with chronic/low clinical activity scores (CAS). Notably, CAS is a measure of disease activity. The phase IV study is being conducted to better inform physicians and payers on the safety and efficacy of TEPEZZA in TED patients with a low CAS.
The study achieved both its primary and key secondary endpoints of reduction in proptosis and proptosis responder rate, respectively, at week 24 of the study with statistical significance. This supports the efficacy of Tepezza across a broad spectrum of TED patients. The drug also displayed a well-established safety profile.
In the past year, shares of Horizon have fallen 2.8% compared with the industry’s 12.9% decline.
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In January 2020, the FDA approved Tepezza as a treatment for patients with TED. With this nod, Tepezza became the first FDA-approved medicine for the treatment of active TED, which has a significant unmet need. In September 2021, Horizon Therapeutics enrolled the first patient in a phase IV study evaluating Tepezza for the treatment of TED in adult patients with chronic/low CAS, completing enrollment in the study a year later.
The phase IV study evaluated Tepezza as a treatment in patients aged two to 10 years with an initial diagnosis of TED and low levels of disease activity. On the contrary, the previous pivotal studies of Tepezza (phase II and phase III), on which the original FDA approval was based, evaluated patients with a disease duration of nine months or less and higher levels of disease activity.
The mean duration of disease for Tepezza and placebo patients were 5.1 years and 5.4 years, respectively. The mean CAS for Tepezza and placebo patients were 0.3 and 0.5, respectively.
TED is a progressive and potentially vision-threatening rare autoimmune disease, which often occurs in people living with Graves’ disease. Symptoms of TED include dry eyes and grittiness, redness, swelling and excessive tearing, eyelid retraction, proptosis, pressure and/or pain behind the eyes and diplopia.
Horizon is currently planning to discuss these data with the FDA to determine its next steps.
We would like to remind the investors that Horizon Therapeutics is set to be acquired by biotech giant Amgen AMGN for $116.5 per share in cash or $27.8 billion. The acquisition was announced in December 2022.
The acquisition will add Horizon’s portfolio of rare disease drugs like Tepezza, Krystexxa and Uplizna to Amgen’s broad and diversified portfolio and should be accretive to the bottom line by 2024. Krystexxa is used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Uplizna is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.
Horizon Therapeutics Public Limited Company Price and Consensus
Horizon Therapeutics Public Limited Company price-consensus-chart | Horizon Therapeutics Public Limited Company Quote
Zacks Rank and Other Stocks to Consider
Horizon Therapeutics currently has a Zacks Rank #2 (Buy).
A few other stocks from the same industry worth mentioning are Aptinyx APTX and ADMA Biologics ADMA, both carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 45 cents. In the past year, shares of Aptinyx have fallen by 89.9%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 14 cents. In the past year, shares of ADMA Biologics have increased by 65%.
ADMA beat estimates in three out of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 2.88%.
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