Horizon Therapeutics plc ( HZNP announced that it has submitted a Biologics License Application (BLA) to the FDA for its investigational medicine, teprotumumab, for the treatment of active thyroid eye disease (TED). The BLA submission is supported by results 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.
Results from the OPTIC study met the primary endpoint of improving proptosis or bulging of the eye compared to placebo. In the study, 82.9% of teprotumumab patients achieved the primary endpoint of a 2 mm or more reduction in proptosis compared to 9.5% of placebo patients. The study also successfully met secondary endpoints and the safety profile was consistent with the phase II study of the drug in TED. The confirmatory OPTIC study was initiated after clinically meaningful and highly statistically significant results from a phase II study, published in The New England Journal of Medicine on May 4, 2017.
Shares of the company have rallied 20.2% year to date compared with the industry 's growth of 3.2%.
Teprotumumab is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the IGF-1R. The drug received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA. The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing. The candidate was added to the company's portfolio after the acquisition of River Vision in 2017.
Horizon is also conducting the OPTIC-X extension trial to get more insight into the long-term efficacy and safety of teprotumumab.
Zacks Rank & Stocks to Consider
Horizon Pharma currently is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the biotech sector are Alnylam Pharmaceuticals Inc. ALNY , Applied Genetics Technologies Corp. AGTC and Acorda Therapeutics Inc. ACOR . While Alnylam sports a Zacks Rank #1 (Strong Buy), Applied Genetics and Acorda carry a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
Alnylam's loss per share estimates have narrowed from $6.90 to $6.43 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 8.93%.
Applied Genetics' loss per share estimates have narrowed from $2.39 to $2.15 for 2020 in the past 90 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.
Acorda's loss per share estimates have narrowed from $3.16 to $3.09 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 79.32%.
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