Horizon Therapeutics plc ( HZNP Quick Quote HZNP - Free Report) announced that it has completed enrollment in the phase IV study evaluating its marketed drug, Tepezza (teprotumumab-trbw), for the treatment of thyroid eye disease (TED) in adult patients with chronic/low clinical activity score (CAS). The study is also called the Tepezza chronic TED study.
The placebo-controlled, multicenter study is evaluating the safety, efficacy and tolerability of Tepezza versus placebo in treating TED in patients with a low CAS.
The primary efficacy endpoint of the study is to see the change from baseline in proptosis (eye bulging) in the study eye at week 24 of treatment.
Shares of Horizon have plunged 41.8% this year compared with the
industry’s decrease of 25.2%. Image Source: Zacks Investment Research
In September 2021, HZNP enrolled the first patient in the phase IV study evaluating Tepezza for the treatment of chronic (inactive) TED, a serious and potentially vision-threatening rare autoimmune disease.
Per the company, TED starts in an acute (active) phase where inflammatory symptoms like eye pain, swelling, proptosis and diplopia (double vision) progress over time. Treatment with Tepezza has improved such TED symptoms when administered in the chronic phase.
In January 2020, the FDA approved Tepezza as a treatment for patients with TED. Following this nod, Tepezza became the first and only FDA-approved medicine for the given indication.
In the first six months of 2022, Tepezza generated net sales worth $981.2 million, up 115.5% year over year.
In April 2021, Tepezza was relaunched in the United States after sales were negatively impacted by a short-term supply disruption due to the U.S. government-mandated COVID-19 vaccine orders in the previous quarters.
In November 2021, Horizon enrolled the first patient in a phase I exploratory study evaluating Tepezza in patients with diffuse cutaneous systemic sclerosis (dcSSc). A potential label expansion is likely to boost sales of the drug in the days ahead.
Zacks Rank & Stocks to Consider
Horizon currently carries a Zacks Rank #5 (Strong Sell).
Better-ranked stocks in the biotech sector include
Aptose Biosciences Inc. ( APTO Quick Quote APTO - Free Report) , Atara Biotherapeutics, Inc. ( ATRA Quick Quote ATRA - Free Report) and ORIC Pharmaceuticals, Inc. ( ORIC Quick Quote ORIC - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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