Horizon Therapeutics plc (HZNP - Free Report) recently announced that the FDA has accepted the Biologics License Application (BLA) for its investigational medicine, teprotumumab, for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation. If approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED.
Teprotumumab is a fully human monoclonal antibody (mAb), and a targeted inhibitor of the IGF-1R. The candidate was added to the company’s portfolio after the acquisition of River Vision in 2017.
Notably, a Priority Review designation is granted to drugs which have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The designation is intended to shorten the FDA review period to six months from the standard 10 months.
The FDA completed its filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA set an action date of Mar 8, 2020.
The FDA notified that it is currently planning to hold an advisory committee meeting to discuss the application per guidelines. Additionally, the FDA notified Horizon that, at this time, it has not identified any potential review issues, although its current filing review is only a preliminary evaluation of the application and is not indicative of deficiencies which may be identified during the review. If any major deficiency is not identified during the review, the FDA plans to communicate proposed labeling and if necessary, any post-marketing requirement requests, by late December 2019.
Shares of the company have rallied 35.9% year to date against the industry’s decline of 2.7%.
The company submitted a BLA to the FDA for teprotumumab in July 2019. 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 the insulin-like growth factor receptor (IGF-1R) is overexpressed on eye tissues.
Zacks Rank & Stocks to Consider
Horizon Pharma is a Zacks Rank #3 (Hold) stock, currently.
Some better-ranked stocks in the biotech sector are Amgen Inc. (AMGN - Free Report) , Acorda Therapeutics Inc. (ACOR - Free Report) and Celcuity Inc. (CELC - Free Report) . All of these sport a Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Amgen’s earnings per share estimates have increased from $13.90 to $14.30 for 2019, and from $14.78 to $15.42 for 2020, in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 6.72%.
Acorda’s loss per share estimates for the current year narrowed from $3.59 to $2.74 over the past 60 days. The company recorded a positive earnings surprise in the preceding four quarters, the average beat being 69.68%.
Celcuity’s loss per share estimates narrowed from 81 cents to 70 cents for 2019 and from 96 cents to 71 cents for 2020, in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 25.76%.
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