We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Horizon Therapeutics Eye Drug Gets Positive FDA Advisory Vote
Read MoreHide Full Article
Horizon Therapeutics plc. 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.
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.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q3 2019, while the S&P 500 gained +39.6%, five of our strategies returned +51.8%, +57.5%, +96.9%, +119.0%, and even +158.9%. This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
Image: Bigstock
Horizon Therapeutics Eye Drug Gets Positive FDA Advisory Vote
Horizon Therapeutics plc. 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.
Horizon Therapeutics Public Limited Company Price
Horizon Therapeutics Public Limited Company price | Horizon Therapeutics Public Limited Company Quote
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 - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and Innoviva Inc. (INVA - Free Report) , 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.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q3 2019, while the S&P 500 gained +39.6%, five of our strategies returned +51.8%, +57.5%, +96.9%, +119.0%, and even +158.9%. This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
See their latest picks free >>