Back to top

Image: Shutterstock

Horizon (HZNP) Completes Enrollment in Phase IV TED Study

Read MoreHide Full Article

Horizon Therapeutics plc (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%.

Zacks Investment Research
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 - Free Report) , Atara Biotherapeutics, Inc. (ATRA - Free Report) and ORIC Pharmaceuticals, Inc. (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.

Aptose Biosciences’ loss per share estimates narrowed by 15.7% for 2022 and 15% for 2023 in the past 60 days.

Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.

Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.

Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.

ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.

Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.

Published in