Gilead Sciences (GILD) Receives FDA Approval | What’s Next?

Gilead Sciences, Inc. (NASDAQ: GILD)

Gilead Sciences had a strong start in the market this morning after announcing that they have received FDA approval for the use of Letairis in combination with Tadalafil. Today, we’ll talk about the details of the approval, how the market reacted to the news and what we can expect to see from GILD moving forward.

GILD Receives FDA Approval For Combination Treatment

As mentioned above, Gilead Sciences announced this morning that they have received approval from the FDA for the use of Letairis combined with tadalafil. The approval is for the combination treatment of pulmonary arterial hypertension with a goal of reducing the risk of disease progression and hospitalization and to improve patients’ ability to exercise. Letairis was first approved by the FDA in 2007 as a monotherapy for pulmonary arterial hypertension. However, it wasn’t until today that the combination of Letairis and tadalafil was approved. Here’s what Ronald J. Oudiz, MD, Professor of Medicine at the David Geffen School of Medicine at UCLA had to say about the positive news…

The evidence to support the use of ambrisentan and tadalafil in PAH is well-established, however an outstanding question has been whether combining these two medications up front may further delay the progresson of this disease over the long term for patients who are newly starting PAH therapy… Based on the data supporting today’s approval, we now know that patients receiving ambrisentan and tadalafil up front are less likely to experience disease progression or be hospitalized, and have more improvement in exercise ability than patients receiving either effective therapy alone. As such, this combination represents a new treatment strategy for patients living with this debilitating and life-threatening disease.”

How The Market Reacted To The News

In early trading GILD was in the midst of a rally, growing from $98.28 per share to $100.95 per share by 9:35. However, since early trading, we have seen declines on the stock. Currently (11:47), GILD is trading at $98.02 per share after a loss of 0.26% so far today.

What We Can Expect To See Moving Forward

First and foremost, I’d like to mention that the declines we’re seeing from GILD in today’s session are not at all justified. The bottom line is that Gilead Sciences has not only maintained control of the HCV market, but plays a major role in several other markets. Now, GILD has received approval that is likely to increase sales of yet another medication. With all of that said, I’m expecting to see a strong recovery tomorrow. Also, in the long term, I have an incredibly bullish opinion of what we can expect from the stock. At its current rate, GILD is oversold and incredibly undervalued. Therefore, the stock is presenting an incredible growth opportunity!

What Do You Think?

Where do you think GILD is headed and why? Let us know your opinion in the comments below!

[Image Courtesy of Mercury News]

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