U.S. Markets close in 2 hrs 32 mins
  • S&P 500

    +22.94 (+0.63%)
  • Dow 30

    +174.12 (+0.58%)
  • Nasdaq

    +68.05 (+0.55%)
  • Russell 2000

    +32.42 (+1.75%)
  • Crude Oil

    +0.50 (+1.10%)
  • Gold

    -2.10 (-0.11%)
  • Silver

    +0.12 (+0.49%)

    +0.0003 (+0.0243%)
  • 10-Yr Bond

    +0.0440 (+4.78%)
  • Vix

    -0.44 (-2.07%)

    +0.0036 (+0.2657%)

    +0.2200 (+0.2118%)

    -289.40 (-1.50%)
  • CMC Crypto 200

    -7.57 (-2.00%)
  • FTSE 100

    +59.96 (+0.92%)
  • Nikkei 225

    -58.13 (-0.22%)

Horizon Therapeutics Gets FDA Approval for Eye Drug Tepezza

Zacks Equity Research

Horizon Therapeutics plc HZNP announced that the FDA has granted approval to Tepezza (teprotumumab-trbw) as a treatment for patients with thyroid eye disease (“TED”). Previously, the FDA had set an action date of Mar 8, 2020.

With this approval, Tepezza becomes the first FDA-approved medicine for the treatment of active TED, which has a significant unmet need. An FDA advisory committee had recommended the approval of the drug in December last year.

The company will conduct a post-marketing study to evaluate safety of Tepezza in a larger patient population, as part of the discussion with the advisory committee.

Shares of Horizon Therapeutics were up 2% in pre-market trading on Jan 22, following the early approval. The company’s shares have surged 74.9% in the past year against the industry’s decline of 1.4%.


The company had filed a biologics license application for Tepezza in July 2019 based on data from the phase III confirmatory study, OPTIC, and positive phase II results. TED is a rare, autoimmune disease in which the insulin-like growth factor receptor (IGF-1R) is overexpressed on eye tissues.

The OPTIC study found that significantly more patients treated with teprotumumab had a meaningful improvement in proptosis, or bulging of the eye, as compared to placebo (82.9% of teprotumumab patients compared to 9.5% of placebo patients). All secondary endpoints were also met. The study was initiated after the phase II study demonstrated clinically meaningful and highly statistically significant results in reducing proptosis and in the symptoms of TED, as measured by overall treatment response.

While developing novel therapies for rare disease, Horizon Therapeutics is also focused on label expansion of key drugs like Krystexxa, Actimmune, Procysbi and Ravicti.

In October 2019, the company initiated the PROTECT study, evaluating the effect of Krystexxa on serum uric acid levels in kidney transplant patients with uncontrolled gout. Actimmune is currently being developed in combination with Roche’s RHHBY Herceptin, or Bristol-Myers’ BMY Opdivo and Merck’s MRK Keytruda, targeting several cancer indications.

Horizon Therapeutics reports through the Orphan and Rheumatology segment, and the Inflammation segment. The company’s net sales in the first nine months of 2019 were $936.5 million, up almost 10% year over year. Tepezza’s approval is likely to boost its sales in 2020.

Horizon Therapeutics Public Limited Company Price


Horizon Therapeutics Public Limited Company Price
Horizon Therapeutics Public Limited Company Price

Horizon Therapeutics Public Limited Company price | Horizon Therapeutics Public Limited Company Quote

Zacks Rank

Horizon Therapeutics currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Just Released: Zacks’ 7 Best Stocks for Today

Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year.

These 7 were selected because of their superior potential for immediate breakout.

See these time-sensitive tickers now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
Horizon Therapeutics Public Limited Company (HZNP) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research