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Horizon Therapeutics Eye Drug Gets Positive FDA Advisory Vote

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Horizon Therapeutics plc. (HZNP - Free Report) announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the FDA voted unanimously that the potential benefits of the company’s pipeline candidate, teprotumumab, outweigh the potential risks for the treatment of Thyroid Eye Disease (TED).

If approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED, which has a significant unmet need. Also the potential approval of the candidate will boost sales for the company.

Teprotumumab is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor receptor (IGF-1R). The candidate was added to the company’s portfolio after the acquisition of River Vision in 2017.

Shares of the company have surged 68.1% year to date compared with the industry’s growth of 7.2%.

The FDA is currently evaluating a Biologics License Application (BLA) for teprotumumab for the treatment of TED, which was submitted in July. The candidate has been granted Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations by the FDA. The FDA has set an action date of Mar 8, 2020. The BLA submission was supported by results from the phase III confirmatory study, OPTIC, and positive phase II results. TED is a rare, autoimmune disease, in which 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.

 

Zacks Rank & Stocks to Consider

Horizon Pharma is a Zacks Rank #3 (Hold) stock, currently.

A few better-ranked stocks in the biotech sector are Alkermes Plc. ALKS, Anika Therapeutics Inc. ANIK and Innoviva Inc. INVA, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.  

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.

Innoviva’s earnings per share estimates have increased from $1.71 to $2.03 for 2019 and from $1.07 to $1.34 for 2020 in the past 60 days.

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