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Horizon (HZNP) Begins Phase IV Study on Tepezza for Chronic TED

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Horizon Therapeutics Public Limited Company (HZNP - Free Report) announced that it has enrolled the first patient in a phase IV study evaluating its marketed drug, Tepezza (teprotumumab-trbw), for the treatment of chronic (inactive) thyroid eye disease (“TED”), a serious and potentially vision-threatening rare autoimmune disease.

The randomized, placebo-controlled study is evaluating the safety, efficacy and tolerability of Tepezza as compared to placebo in treating patients with chronic TED. The primary efficacy endpoint of the study is to see the change from baseline in proptosis (eye bulging) in the affected eye at week 24 of treatment.

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.

Shares of Horizon have rallied 49.1% so far this year compared with the industry’s increase of 2.8%.

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We remind investors that, in January 2020, the FDA granted approval to 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 second quarter of 2021, Tepezza generated net sales worth $453.3 million, up 173% 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 U.S. government-mandated COVID-19 vaccine orders in the previous quarters.

The company expects Tepezza’s net sales to be greater than $1.55 billion in 2021.

Horizon is planning to initiate an exploratory study on Tepezza in diffuse cutaneous systemic sclerosis, shortly. Also, a phase I pharmacokinetic study is currently underway to explore subcutaneous administration of Tepezza. Potential label expansion will boost sales of the drug in the future quarters.

Zacks Rank & Other Stocks to Consider

Horizon currently carries a Zacks Rank #2 (Buy). Top-ranked stocks in the healthcare sector include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Repligen Corporation (RGEN - Free Report) and Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) , all carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised 9.3% upward for 2021 and 6.8% upward for 2022 over the past 60 days. The stock has surged 38.5% year to date.

Repligen’s earnings estimates have been revised 22.1% upward for 2021 and 17.9% upward for 2022 over the past 60 days. The stock has soared 54.6% year to date.

Ironwood’s earnings estimates have been revised 18% upward for 2021 and 45.7% upward for 2022 over the past 60 days. The stock has increased 10.3% year to date.