Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) pharmaceuticals is having an overwhelmingly strong start to the trading session this morning after announcing data from a pivotal Phase 2 clinical study. As you could imagine, the data was positive, sending the stock on a run for the top. Today, we’ll talk about the data, what we’re seeing from the stock, and what we’ll be watching for with regard to ALXN ahead.
ALXN Reports Strong Data
As mentioned above, Alexion Pharmaceuticals is having an incredibly strong start to the trading session this morning after reporting clinical data. In a press release issued early this morning, the company announced that the pivotal Phase 3 study of ALXN1210, an investigational long-lasting C5 Complement inhibitor, showed non-inferiority to Soliris®. The data came from complement inhibitor treatment-naive patients with paroxysmal nocturnal hemoglobinuria (PNH).
In the release, ALXN said that the conclusion came based on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (LDH) levels. In the release, the company said that the study also demonstrated non-inferiority on all four key secondary endpoints. These endpoints included percentage change from baseline in LDH levels, change from baseline in quality of life, proportion of patients with breakthrough hemolysis, and proportion of patients with stabilized hemoglobin levels. In a statement, John Orloff, M.D., Executive Vice President and head of R&D at ALXN, had the following to offer:
We are very pleased with these positive data for ALXN1210 in the first and only head-to-head study versus Soliris, and the results reinforce our ambition to establish ALXN1210 as the new standard of care for patients with PNH. The data are also consistent with our hypothesis that immediate, complete, and sustained C5 inhibition is critical for patients with this potentially life-threatening disease… Soliris has established a high bar for efficacy. Achieving non-inferiority on both co-primary and all key secondary endpoints, as well as seeing numeric results in favor of ALXN1210, in such a rigorous study met a very high hurdle. We look forward to regulatory submissions of ALXN1210 in PNH in the U.S., EU, and Japan in the second half of 2018.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news was overwhelmingly positive. After all, not only was the data from the clinical trial positive data, the trial was a pivotal trial. This means that Alexion will likely push for regulatory approval of ALXN1210 relatively soon. So, it’s no surprise to see that the stock is making a run for the top in the market today. Currently (9:29), ALXN is trading at $137.45 per share after a gain of $14.77 per share or 12.04% 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 ALXN. In particular, we’re interested in following the continued development of ALXN1210 and excited to see the push toward regulatory approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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