Horizon Pharma PLC (NASDAQ: HZNP) is climbing early on in the trading session this morning, and for good reason. The company announced the results of a Phase 3 trial, meeting all primary and secondary endpoints.
As we have come to expect, the positive clinical data is sending the stock on a move upward. Today, we’ll talk about:
- The clinical data;
- what we’re seeing from HZNP stock as a result; and
- what we’ll be watching for ahead.
HZNP Announces Positive Clinical Data
As mentioned above, Horizon Pharma is having a great start to the trading session this morning after the company announced positive clinical data. The data came via press release and was produced through a Phase 3 confirmatory clinical trial.
In the trial, HZNP evaluated teprotumumab as a treatment for active thyroid eye disease (TED). In the release, the company said that the treatment showed a meaningful improvement in proptosis, or bulging eye, when compared to placebo. This was the primary endpoint of the trial.
The company also said that all secondary endpoints were met. The treatment also had a strong safety and tolerability profile. As a result, the company said that it plans on submitting a Biologics License Application to the United States FDA in mid-2019.
In a statement, Timothy P. Walbert, Chairman, President and CEO at HZNP, had the following to offer:
The dramatic results of the teprotumumab Phase 3 confirmatory trial, in addition to positive Phase 2 data, form a highly convincing body of clinical evidence supporting teprotumumab for the treatment of active thyroid eye disease. This is a key milestone as we evolve into a research-focused company developing innovative new medicines to address challenging diseases with very few effective options. We are one step closer to delivering the first FDA-approved treatment to people living with active thyroid eye disease, and we are grateful to the patients, physicians and investigational sites who have partnered with Horizon to make the teprotumumab research and development program possible.
The above statment was followed up by Raymond Douglas, M.D., Ph.D., co-principal investigator and director of the orbital and thyroid disease program at Ceders-Sinai Medical Center, had the following to offer:
In the study, patients treated with teprotumumab had an unprecedented reduction in proptosis, which is currently only treatable via surgery after the active disease has ended. If approved, teprotumumab would give physicians the first medicine shown to reduce proptosis during active thyroid eye disease, in addition to treating other painful symptoms.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of Horizon Pharma, the news proved to be overwhelmingly positive.
After all, the positive clinical data will open the door to the company’s ability to submit a BLA with the FDA. Should all go well, the treatment will hit the market relatively soon, creating a revenue opportunity.
Considering this, it’s not a shocker to see that excited investors are pushing the stock up in the market this morning. At the moment (10:01), HZNP is trading at $27.27 per share after a gain of $5.42 per share or 24.78% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on HZNP. In particular, we’re interested in following the story surrounding the company’s continued work to bring its teprotumumab product to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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