Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
Regeneron Pharmaceuticals is having an overwhelmingly hard day in the market today, and for good reason. Investors have seen news that the approval for a lead candidate may be delayed from the FDA. Below, we’ll talk about what we’re seeing from the stock, why, and what we can expect to see from REGN ahead.
What We’re Seeing From REGN Today
As mentioned above, Regeneron Pharmaceuticals is having an overwhelmingly rough day in the market today. All day, the stock has been trading in the red. Currently (1:48), REGN is trading at $356.27 per share after a loss of $9.08 per share or 2.49%. We are also hearing news that due to the release, shares have been halted.
Why We’re Seeing The Drop
The declines in REGN are relatively simple to understand. The company was working with a company known as Sanofi for the development of Serilumab. At the moment, investors are waiting for news from the FDA with regard to the New Drug Application surrounding the treatment.
Unfortunately, that news came out today, and it wasn’t good. According to a release, it is expected that the approval of Serilumab will be delayed, and it’s causing Regeneron Pharmaceuticals to take a dive.
The reason that the FDA approval will be delayed had to do with manufacturing deficiencies. In a statement, the company said that “manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice inspection of a Sanofi manufacturing facility.”
UPDATE: FDA releases Complete Response Letter. To read it, click here!
What We Can Expect To See Ahead
While this news is hard hitting, and very negative for the short term view on REGN, it’s not news that is going to kill the company. At this point, approval is delayed, not for safety or efficacy issues, but for manufacturing issues. These types of issues are easily fixed with due time. As a result, while we may see short run declines, I’m expecting to see gains in REGN ahead.
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[Image Courtesy of PEXELS]